The Pharmaceutical Compliance Forum

Employment

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EMPLOYMENT OPPORTUNITIES

 

POLICY & TRAINING MANAGER - Exelixis
Location: Alameda, CA US
Divisions: G&A
Job Code: TBD
FLSA Status: Exempt
Reports To: Lori Parenti


SUMMARY:
The Exelixis Compliance Program sets policies and procedures, conducts training, and continually monitors and audits operational activities at the company in connection with a variety of laws and regulations, including but not limited to US healthcare laws governing interactions with healthcare professionals (HCP), FDA regulations, and privacy laws. The Compliance Training Manager will assist in maintaining and enhancing Exelixis' written policies, procedures and work instruction, and the various forms of training devised to educate the Exelixis workforce accordingly. More specifically, this individual will be responsible for supporting training project and program deliverables that align to our compliance training plan and related communications. Essential business partners for this role are Commercial, Medical Affairs, Quality Assurance, Finance, Legal and HR.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Evaluate policies and procedures, considering how to maximize the effectiveness of their content so they are understandable and accessible to the appropriate audience
  • Contribute to the technical writing and standardization of policy and procedural documents
  • Support ongoing development and design of our Business Conduct Manual (BCM) and related training and communication
  • Contribute to our annual training plan development and implementation and ongoing improvement
  • Proactively identify and address training gaps that address compliance issues/risks
  • Assist in compliance training strategy to support online and live training events
  • Pull through internal training initiatives (e.g., Compliance Corner Newsletters, Compliance Champion engagement)
  • Leverage internal/external survey platforms to measure training success and gather feedback
  • Support our Learning Management System (ComplianceWire) for recording, reporting and tracking compliance training
  • Vendor management support
  • Respond to inquiries sent to internal compliance mailbox
  • As assigned, assist with other department duties and/or projects

SUPERVISORY RESPONSIBILITIES:

  • None

EDUCATION/EXPERIENCE:

  • BS/BA degree in related discipline
  • 3-5 years of relevant professional experience
  • CPA, CIA, CFE, CCEP certification is a plus
  • Technical writing experience demonstrated by writing samples
  • Experience in biotech/pharmaceuticals/healthcare - preferred but not required

KNOWLEDGE/SKILLS/ABILITIES:

  • Ability to create engaging content that supports adult learning principles
  • Passion for presenting and public speaking
  • Ability to work independently and be a confident collaborator
  • Excellent verbal and technical writing skills
  • Strong organizational (detail oriented), project management, and problem-solving skills
  • Ability to handle multiple tasks, prioritize appropriately
  • Must be responsible, conscientious, and professional
  • Dedication to quality and the highest professional standards
  • Must be a self-starter and quick learner
  • Advanced computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint), InDesign, Acrobat)

JOB COMPLEXITY:

  • Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. May also work on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Exercises judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Networks with key contacts outside own area of expertise.

DISCLAIMER
The preceding job description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to the job.

 Apply here
Posted 2/13/2020

CORPORATE COMPLIANCE LEAD - Spark Therapeutics, Inc.
Location: Philadelphia, PA
Title of Position Reporting To: Head of Corporate Compliance
Department: Corporate Compliance
Job Level: M4
FLSA (Exempt or Non-Exempt): Exempt

Primary Duties
The Corporate Compliance Lead provides compliance advice and guidance to the Corporate Compliance department and to Spark Therapeutics, Inc. ("Spark" or "the Company") global research and development ("R&D"), clinical, and commercial business units regarding the Company's Code of Conduct and Business Ethics ("Code"), Corporate Compliance policies and standards, and other compliance issues and inquiries. The Corporate Compliance Lead supports compliance with laws and regulatory requirements of local, state, and federal agencies, as well as Spark's compliance policies and procedures. In collaboration with the Corporate Compliance team, this role establishes and implements the Corporate Compliance Program to ensure its effectiveness in promoting and enforcing the Code and compliance policies and procedures, as well as preventing, detecting, and correcting non-compliance with the Code, compliance policies and procedures, and applicable laws and regulations. This role advises and supports compliance investigations to ensure that such investigations are conducted in a timely, objective and comprehensive manner and appropriate corrective action is implemented in accordance with the Company's compliance policies and procedures. The Corporate Compliance Lead collaborates with key stakeholders across cross-functional business units to ensure that the Code and Corporate Compliance Program are implemented appropriately and enforced consistently. This role interacts with and advises Functional Heads and the Senior Leadership Team ("SLT") on compliance matters that affect the success of the Company and the execution of the Company's strategic business priorities. The Corporate Compliance Lead, in collaboration with the Corporate Compliance team, develops, updates, and implements Corporate Compliance Program strategies, policies and procedures, oversight processes, and program controls. This role participates in the Corporate Compliance training program to deliver timely and targeted education to Spark business units. The Corporate Compliance Lead monitors global compliance, and regulatory matters throughout the pharmaceutical/biotech industry, as well as regulations and guidances of local, state, and federal agencies, to identify those issues, changes, and emerging risks that may affect the Company and to assist with implementing modifications, as needed, to the Corporate Compliance Program and/or Spark's business operations.


Responsibilities

Compliance Program Monitoring and Risk Mitigation

  • Implement Spark's Corporate Compliance Program. Ensure that compliance policies, procedures, and training are developed, adopted, published, and communicated to all employees, and other relevant stakeholder to prevent illegal, unethical, non-compliant and/or improper conduct.
  • Maintain Corporate Compliance policies and procedures to ensure currency with emerging laws, regulations, and trends of local, state, and federal agencies and applicable changes relevant to legal and compliance risks throughout the pharmaceutical/biotech industry.
  • Periodically review and update the Code to ensure continued relevance in providing guidance to employees, management, senior leadership, and external individuals and entities, and to deliver required training on the Code, as needed.
  • Actively monitor regulatory agencies and the pharmaceutical/biotech industry for best practices, emerging trends, and potential risks in corporate compliance.
  • Champion an ethical culture in which compliance and business objectives are mutually reinforcing and the Corporate Compliance Program is well integrated into the Company's business activities.
  • Partner with Functional Heads and members of the SLT to maintain and enhance a strong culture of compliance, including personal accountability at all levels in the organization, with a spirit of partnership and positive problem-solving.
  • Evaluate issues and respond to inquiries regarding application of the Code and related policies and procedures. Advise and guide Functional Heads to resolve any related challenges.
  • Partner with the Corporate Compliance Operations Leader regarding monitoring and auditing activities relative to the Code and compliance policies and procedures. Advise on appropriate corrective action in response to irregularities identified from compliance monitoring and auditing activities.
  • Ensure that compliance issues or concerns are appropriately evaluated, investigated, and resolved, and any remediation is conducted using an effective and consistent system of discipline to address misconduct.
  • Partner with the Corporate Compliance team and/or Legal to facilitate, track, and support, where appropriate, any investigations of potential non-compliance with the Code or the Corporate Compliance Program. As needed, assist with the implementation and ongoing monitoring of any corrective action.
  • Assist the Head of Corporate Compliance by implementing periodic risk assessments, audits, and reporting procedures to identify potential areas of compliance vulnerability and risk. Implement preventative and corrective action plans to mitigate identified risks.
  • Provide reports on a regular basis, and as directed or requested by the Head of Corporate Compliance, to inform management regarding the operation and progress of the Corporate Compliance Program.

Compliance Advisement to Legal, Business Units, and Senior Leadership
Business Units

  • Partner with, support, and advise cross-functional business units regarding the mitigation of risk assessment activities to optimally manage and avoid issues with compliance risk.
  • Serve as the Corporate Compliance liaison to Functional Heads and cross-functional teams to address compliance inquiries and challenges, design and implement customized policies and procedures, and achieve business goals in compliance with relevant laws and regulations and Corporate Compliance policies and procedures.
  • Provide compliance advice and insight to Functional Heads and cross-functional teams regarding various R&D and commercial initiatives. Participate as the Corporate Compliance representative on cross-functional teams to advise on the full spectrum of activities from concept proposal to final execution.
  • Advise Functional Heads and cross-functional teams on general or specific compliance legal matters related to the Company's business strategies and initiatives.
  • Create, maintain, and evaluate appropriate reporting related to the Corporate Compliance Program. Develop and present, as needed, reports and presentations to Functional Heads and cross-functional teams.
  • Support other compliance projects and initiatives, as requested, by the Head of Corporate Compliance to provide targeted solutions to Functional Heads and cross-functional teams.

Corporate Compliance Policy Development, Monitoring, and Training

  • Design and implement enhancements to the Corporate Compliance Program and promote awareness of, conduct training for, and ensure adherence to the Code and related policies, procedures, and guidelines.
  • Develop, publish, maintain, and interpret compliance policies and procedures as may be appropriate to fully implement the provisions of the Code and related compliance policies and procedures and/or to meet the requirements of applicable statutes, regulations, and business standards.
  • Collaborate with the Corporate Compliance team to develop new policies and training in response to changes concerning laws, regulations, and guidances that affect Corporate Compliance policies and procedures.
  • Collaborate with the Corporate Compliance team to develop and revise, as needed, risk assessment plans and auditing and monitoring protocols.
  • Monitor and present emerging trends in compliance training to the Corporate Compliance team to ensure that the compliance training program is dynamic and fully reflects leading practices for content development and delivery formats for compliance training.
  • Partner with the Corporate Compliance Operations Leader to prepare and deliver compliance training to all employees to ensure understanding of and adherence to the Corporate Compliance Program and related compliance policies and procedures.

Compliance and Business Ethics Helpline

  • Participate in investigations arising from reports submitted to the Compliance and Business Ethics Helpline regarding alleged violations related to the Code and Company policies or procedures.
  • Advise and guide on any violations that require remediation, recommend appropriate corrective action, and participate in discussions with Functional Heads, Legal and/or HR to implement remediation plans. As needed, support ongoing monitoring to ensure full compliance with Company policies and procedures.

Communications to Senior Leadership and Board of Directors

  • Design, develop, and present reports and presentations to the cross- functional teams and SLT, CMT, and BOD or assist the Head of Corporate Compliance with these communications.
  • Bachelor's Degree in related field required (e.g., life sciences, law, public policy, business management, training and development)
  • Graduate-level degree required (e.g., JD, MBA, MS, CPA, or related discipline)
  • Generally, 10 or more years of experience in the biotech/biopharma/pharma industry with pharmaceutical products intended for human use or with other life-science regulated industries. Strong experience in global healthcare compliance or legal department(s) with a demonstrated deep understanding of the complex functions of a pharmaceutical organization and the associated legal, regulatory, and compliance matters of the industry.
  • 5 years or more of experience preferred with developing and monitoring a corporate compliance program and associated policies, procedures, and training; conducting and resolving internal investigations; and partnering effectively with cross-functional teams to advise on compliance matters and challenges.
  • Deep and well-rounded knowledge of applicable federal, state, and local laws and regulations that affect Spark's Corporate Compliance Program (e.g., OIG Compliance Program Guidance for Pharmaceutical Manufacturers, PhRMA Code on Interactions with Healthcare Providers, industry guidance documents, CIA trends, Stark Law, HIPAA, regulations regarding the promotion of marketed products, EFPIA and the False Claims Act, and Anti-Kickback Statutes).

Key Skills, Abilities, and Competencies

  • Excellent organizational, advocacy and facilitation skills to effectively implement the Corporate Compliance Program and manage change, as needed, and to engage others to implement changed processes to ensure ongoing compliance with the Corporate Compliance Program
  • Excellent written and verbal communication skills; excellent public speaking/presentation skills and experience with designing and presenting training materials
  • Demonstrated ability to operate in an entrepreneurial, responsive, and collaborative style focused on advancing Spark's business priorities while ensuring adherence to the Company's compliance programs and projects
  • Proven experience building and cultivating relationships with key partners and stakeholders across all organizational levels
  • Strong ability to build credibility and communicate effectively with individuals and teams in Spark business units and to inspire confidence and support for compliance initiatives
  • Strong collaboration, critical thinking and negotiation skills to influence cross-functional teams in problem resolution and to direct decisions toward desired outcomes (e.g., resolution of compliance investigations)
  • Ability to resolve compliance challenges across the organization while demonstrating discretion, confidentiality, and respect for colleagues • Proficient interviewing and interrogation skills that achieve effective outcomes while eliciting trust and demonstrating courtesy and respect
  • Experience and confidence with counseling regarding compliance matters
  • Impeccable ethics and proven abilities to reflect, support and promote Spark's values

Complexity and Problem Solving

  • Ability to think critically, strategically and quickly analyze complex compliance circumstances and problems
  • Demonstrated ability to synthesize information from diverse sources, develop options for resolution, make decisions that are rational and based on sound evidence, and determine an action plan, as needed
  • Ability to oversee projects and successfully complete them in an organized, efficient, and effective manner
  • Ability to provide sound compliance-related advice and recommendations
  • Proven ability to advise on complex compliance-related matters and communicate information concisely and effectively to cross-functional business teams
  • Ability to work in a dynamic, fast-paced environment with shifting priorities and to interact successfully in a global company with a culturally diverse workforce

Internal and External Contacts

Senior Leadership and BOD

  • Design, develop, and present reports and presentations to the SLT, CMT, and/or BOD or assist the Head of Corporate Compliance with these communications.

Corporate Compliance Management Team

  • Assist the Head of Corporate Compliance and Compliance team members, as needed, with assigned activities to support Corporate Compliance matters, policies, programs, and initiatives.

Cross-functional Teams, Functional Heads, and Stakeholders

  • Advise, guide, and collaborate with business units throughout the Company and lead discussions to respond to inquiries, identify needs and challenges, design customized solutions, and implement action plans regarding the Corporate Compliance Program.

External Law Firms

  • Seek and incorporate, as appropriate, ad hoc advice related to the Corporate Compliance Program and other compliance matters.

Third-party Service Providers/External Vendors

  • Manage third-party service providers for various programs and/or services, as needed.

Other Job Requirements

  • Domestic and international travel is required on a per project basis.

 Apply here
Posted 1/31/2020

E&C CORPORATE PARTNER - UCB
Location: Smyrna, Georgia, United States
Job Function: Legal
Job ID: 66182

Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen the Ethics and Compliance Team based in Smyrna, Georgia or Brussels, Belguim, we are looking for a talented individual to fill the position of: ETHICS AND COMPLIANCE CORPORATE PARTNER.

The Ethics & Compliance (E&C) Corporate Partner will work with global teams (Mission, Centers of Excellence, Functions) to implement effective Ethics & Compliance programs, including prospectively identifying ethics and compliance risks and actively preparing for future business needs. The E&C Corporate Partner acts as the E&C contact for assigned business teams and advise global business colleagues on E& C related-matters, driving integration of E&C into their strategies and activities. This role may support design of global solutions as subject matter expert. This individual can work in the Headquarters in Brussels, Belgium or Smyrna, Georgia.


You like to work in an environment where you can:

  • Identify key upcoming needs from the business, trends in the industry and code developments, determining if E&C alignment or solutions already exist or need to be adapted to address such needs.
  • Work with relevant stakeholders, develops, implements, coordinates, and delivers awareness education, policies and procedures training, and other necessary training programs to internal and external business partners.
  • Actively engage the leadership team in each applicable global team in driving the tone from the top in integrity and leveraging communication cascade to the organization to maintain a high level of awareness in ethical business conduct.
  • Champion speak-up, transparency and a culture of integrity throughout the organization.
  • Facilitate flow of communication within respective E&C networks (e.g., corporate leads; Neurology and Immunology).

You will contribute by:

  • Maintaining thorough knowledge of all industry codes, and in cooperation with Legal, of all applicable laws and regulations. Monitor and follow up of key developments that would impact the business.
  • Advising the business regarding existing and future provisions, ensuring appropriate planning and preparation of remediation actions if needed.
  • Providing advice and guidance to globally-led activities and strategies on ethics & compliance matters, including identified risk areas and interactions with healthcare professionals, government officials, healthcare institutions, patients and patient groups.
  • Co-creating and collaborating on business initiatives to foster innovation and creation of meaningful solutions for patients while ensuring integrity and ethical principles are respected.

Interested? For this position, you'll need the following education, experience and skills:
Minimum Qualifications:

  • Bachelor's Degree
  • 5 + years of experience in the pharmaceutical industry.
  • Proficiency in Healthcare Compliance requirements including self-regulated industry codes.

Preferred Qualifications:

  • Master's Degree preferred.
  • Prior management/supervisory experience preferred.
  • Experience (direct or indirect - confronted and operated) in healthcare compliance.

About Us
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

 Apply here
Posted 1/31/2020

E&C OPERATIONS PARTNER (Monitoring and Analytics) - UCB
Location: Smyrna, Georgia, United States
Job Function: Sales
Job ID: 66170

Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen the Ethics and Compliance Team based in Smyrna, Georgia, we are looking for a talented individual to fill the position of: ETHICS AND COMPLIANCE OPERATIONS PARTNER.

The Ethics & Compliance (E&C) Operations Partner will work with E&C stakeholders to design, localize and/or operationalize E&C program elements to meet the needs of the assigned geography and as defined by E&C leadership. The E&C Operations Partner (OP) may be a generalist resource or may be specialized in specific elements of the compliance program depending on the needs of the assigned geography. This position will have a focus on Monitoring and Analytics.


You like to work in an environment where you can:

  • Promote a Culture of Ethics & Compliance; including, champion speak-up, transparency and a culture of integrity throughout the organization.
  • Work with the relevant E&C stakeholders to support implementation of compliance program elements.
  • Drive collaboration and creativity, support innovation, and actively contribute to the department and company.

You will contribute by:

  • Supporting the process for documenting the risk assessment and application of the assessment to compliance program elements as appropriate.
  • Creating and implementing training content including tracking as assigned
  • Supplementing the creation/revision/simplification of documented procedures. Supports initiatives, content creation, and dissemination.
  • Assisting with the execution of the annual monitoring plan, supports E&C report creation, provides analysis on trends and figures.

Interested? For this position, you'll need the following education, experience and skills:
Minimum Qualifications:

  • High School Diploma or equivalent
  • 5+ years of professional work experience in compliance, risk management, quality systems, or project management, or related function.
  • Excellent skills in organization, time management, planning, prioritization and attention to detail.

Preferred Qualifications:

  • Bachelor's Degree preferred.
  • Prior pharmaceutical industry experience preferred.
  • Ability to work effectively, collaboratively, and with sensitively in a highly matrixed organization

About Us
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

 Apply here
Posted 1/31/2020

SR. E&C BUSINESS PARTNER - MARKET ACCESS - UCB
Location: Smyrna, Georgia, United States
Job Function: Legal
Job ID: 66183

Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen the Ethics and Compliance Team based in Smyrna, Georgia, we are looking for a talented individual to fill the position of: ETHICS AND COMPLIANCE LEAD - MARKET ACCESS.

The Ethics & Compliance (E&C) Affiliate Lead serves as the primary E&C contact for the Market Access team to implement effective E&C programs to identify and mitigate risks in scope (bribery & corruption, inappropriate promotion, Data Privacy and adherence to local industry regulations). The E&C Affiliate Lead is responsible for the design, localization and/or operationalization of ethics & compliance program elements and for advising business colleagues to drive integration of E&C into their plans & operations. The E&C Affiliate Lead will manage a team of E&C Partners to achieve stated goals.


You like to work in an environment where you can:

  • Work with the relevant stakeholders to ensure Affiliates maximize the effectiveness of the compliance program, ensuring that business leadership is committed to the highest ethical and compliance standards.
  • Drive risk assessments for Ethics & Compliance in the geographical area, ensuring that key stakeholders locally and regionally are informed of relevant risks and implementing remediation plans.
  • Ensure accountability is exercised through enforcement of our policies and applicable regulations; ensures allegation of misconduct are reported timely and discipline actions are implemented after investigations are done. Provides support during investigations as needed.
  • Actively engage the leadership team in each applicable Affiliate in driving the tone from the top in integrity and leveraging communication cascade to the organization to maintain a high level of awareness in ethical business conduct.

You will contribute by:

  • Maintaining thorough knowledge of all industry codes, and in cooperation with Legal, of all applicable laws and regulations. Monitors and follows up of key developments that would impact the business. Advise the business regarding existing and future provisions, ensuring appropriate planning and preparation of remediation actions if needed.
  • Actively participating in local industry trade association compliance (or related) committees, helping drive appropriate decision-making on key issues, integrating best practices and benchmarking into the overall approach.
  • Partnering with Area/Affiliate and Global Internal Audit (GIA) on audits, while maintaining full objectivity and independence from both parties.
  • Conducting (where applicable, in collaboration with E&C operations) due diligence activities of third parties with the Affiliate and associated compliance risk assessment and minimization (e.g. through training) of the pertaining high risk third parties.

Interested? For this position, you'll need the following education, experience and skills:
Minimum Qualifications:

  • Bachelor's degree required.
  • 5+ years of experience in the pharmaceutical industry.
  • Experience (direct or indirect - confronted and operated) in healthcare compliance.

Preferred Qualifications:

  • Master's degree preferred.
  • Prior management/supervisory experience preferred.
  • Experience working in a transnational and multicultural environment

About Us
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

 Apply here
Posted 1/31/2020

E&C BUSINESS PARTNER - MARKET ACCESS - UCB
Location: Smyrna, Georgia, United States
Job Function: Legal
Job ID: 66184

Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen the Ethics and Compliance Team based in Smyrna, Georgia, we are looking for a talented individual to fill the position of: ETHICS AND COMPLIANCE BUSINESS PARTNER - MARKET ACCESS.

The Ethics & Compliance (E&C) Partner partners with Market Access and E&C Leadership to implement effective E&C programs to identify and mitigate risks in scope (bribery & corruption, inappropriate promotion, Data Privacy and adherence to local industry regulations). The E&C Partner is responsible for the design, localization and/or operationalization of ethics & compliance program elements and for advising business colleagues to drive integration of E&C into their plans & operations. The role may support design of global solutions as a subject matter expert.


You like to work in an environment where you can:

  • Work with the relevant stakeholders to ensure Affiliates maximize the effectiveness of the compliance program, ensuring that business leadership is committed to the highest ethical and compliance standards.
  • Drive risk assessments for Ethics & Compliance in the geographical area, ensuring that key stakeholders locally and regionally are informed of relevant risks and implementing remediation plans.
  • Actively engages the leadership team in each applicable Affiliate in driving the tone from the top in integrity and leveraging communication cascade to the organization to maintain a high level of awareness in ethical business conduct.
  • Implement (where applicable, in collaboration with E&C operations) robust monitoring plans based on the risk assessment; communicate results to leadership, analyze root causes and trends.

You will contribute by:

  • Maintaining thorough knowledge of all industry codes, and in cooperation with Legal, of all applicable laws and regulations. Monitors and follows up of key developments that would impact the business. Advise the business regarding existing and future provisions, ensuring appropriate planning and preparation of remediation actions if needed
  • Providing advice and guidance to the business on ethics & compliance matters, including identified risk areas and interactions with healthcare professionals, government officials, healthcare institutions, patients and patient groups.
  • Representing the Ethics & Compliance Team in/to internal and external governance bodies/authorities.
  • Conducting (where applicable, in collaboration with E&C operations) due diligence activities of third parties with the Affiliate and associated compliance risk assessment and minimization (e.g. through training) of the pertaining high risk third parties

Interested? For this position, you'll need the following education, experience and skills:
Minimum Qualifications:

  • Bachelor's degree required.
  • 5+ years of experience in the pharmaceutical industry.
  • Experience (direct or indirect - confronted and operated) in healthcare compliance.

Preferred Qualifications:

  • Master's degree preferred.
  • Experience working in a transnational and multicultural environment

About Us
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

 Apply here
Posted 1/31/2020

E&C OPERATIONS PARTNER - UCB
Location: Smyrna, Georgia, United States
Job Function: Legal
Job ID: 66141

Help us transform patients' lives.
At UCB, we put our heart, soul and skills into making a difference for people living with significant unmet needs. Working together, we blend the best of our talents to deliver thoughtful solutions that patients value. Will you join us in this pioneering adventure?

To strengthen the Ethics and Compliance Team based in Smyrna, Georgia, we are looking for a talented individual to fill the position of: ETHICS AND COMPLIANCE OPERATIONS PARTNER

The Ethics & Compliance (E&C) Operations Partner will work with E&C stakeholders to design, localize and/or operationalize E&C program elements to meet the needs of the assigned geography and as defined by E&C leadership. The E&C Operations Partner (OP) may be a generalist resource or may be specialized in specific elements of the compliance program depending on the needs of the assigned geography.


You like to work in an environment where you can:

  • Promote a Culture of Ethics & Compliance; including, champion speak-up, transparency and a culture of integrity throughout the organization.
  • Work with the relevant E&C stakeholders to support implementation of compliance program elements.
  • Drive collaboration and creativity, support innovation, and actively contribute to the department and company.

You will contribute by:

  • Supporting the process for documenting the risk assessment and application of the assessment to compliance program elements as appropriate.
  • Creating and implementing training content including tracking as assigned
  • Supplementing the creation/revision/simplification of documented procedures. Supports initiatives, content creation, and dissemination.
  • Assisting with the execution of the annual monitoring plan, supports E&C report creation, provides analysis on trends and figures.

Interested? For this position, you'll need the following education, experience and skills:
Minimum Qualifications:

  • High School Diploma or equivalent
  • 5+ years of professional work experience in compliance, risk management, quality systems, or project management, or related function.
  • Excellent skills in organization, time management, planning, prioritization and attention to detail.

Preferred Qualifications:

  • Bachelor's Degree preferred.
  • Prior pharmaceutical industry experience preferred.
  • Ability to work effectively, collaboratively, and with sensitively in a highly matrixed organization

About Us
At UCB, we come together every day to work, laser-focused, on a simple question: How will this create value for people living with severe diseases? By putting patients at the heart of everything we do, our approach - from discovery to development to delivery - is continuously transformed and designed around patient needs and their journey.

With a team of approximately 7,500 employees worldwide operations in more than 40 countries, we are a global biopharmaceutical company investing more than a quarter of our revenue in cutting-edge scientific research. We are focused on addressing chronic, neurological, immunological, and bone diseases. We are looking for people with passion and empathy who develop a real understanding of patient's needs and can deliver thoughtful solutions to decisionmakers across the heath care ecosystem.

Curious to know more? Please visit our website www.ucb.com.

UCB and its subsidiaries encourage diversity and inclusion in the workplace; we are an Equal Opportunity Employer. We do not discriminate on the basis of race/color/religion/sex/national origin/veteran/disability/age/sexual orientation/gender identity.

 Apply here
Posted 1/31/2020

GLOBAL PROGRAM HEAD, VENDOR/THIRD PARTY COMPLIANCE - Otsuka Pharmaceuticals
Location: Can be located in either US, Japan or Europe

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho - the achievement, completion, and discovery of truth; and Sozosei - pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.

Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

Global Program Head, Vendor/Third Party Compliance

This role supports the Global CECO and wider Global Ethics & Compliance team and will be responsible for coordinating our global third-party vendor due diligence program, including setting standards and managing global risks associated with third parties.

**Please note that this position can be located in either US, Japan or Europe


Responsibilities include but not limited to the following:

  • Developing and implementing new global program for third party vendor due diligence and risk management, including vendor management activities and ensuring alignment with business and regulatory strategies
  • Developing consistent global standards for management of third parties.
  • Developing consistent contractual obligations for vendors with regard to compliance as well as Supplier Code of Conduct
  • Proactively identify areas of potential risk and develop proactive global and regional risk mitigation plans and manage issue resolution, incorporating learning to strengthen partnership processes
  • Actively leading large/ high impact third party diligences in specific regions when required, and provide ongoing support and expertise to regionally-based colleagues
  • Working with IT to establish appropriate technology platforms to support global compliance risk assessment efforts
  • Defining management reports/ dashboards and provide regular feedback to regional partners and global/ regional leadership teams

Qualifications:

  • BA or BS Degree required, relevant advanced degree preferred
  • Proficiency in multiple languages desirable
  • Minimum 10 years of experience with due diligence and audit procedures for a pharmaceutical/medical company, and ability to proactively identify risk of non-compliance in complex environments required.
  • Experience in all aspects of managing third party vendors; including contract negotiation, vendor performance management, preparing and evaluating RFPs, relationship management required.
  • Practical operational experience of working across disciplines and across multiple regions required.
  • Experience working within a global team framework and a multi-cultural environment
  • Efficiently/actively manages conflict in a tactful, diplomatic way, seeking effective solutions for all parties.
  • Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
  • Capability to critically analyze complex and/or ambiguous information leveraging excellent analytical, technical and problem-solving skills.
  • Strong communication skills with the ability to express oneself clearly and concisely to a variety of audiences. Ability to understand/analyze/ synthesize and communicate to internal/external stakeholders.
  • Up to 20% domestic and international travel is required based upon business needs.

 Apply here
Posted 1/18/2020

GLOBAL PROGRAM HEAD, POLICY, LEARNING AND ENGAGEMENT - Otsuka Pharmaceuticals
Location: Can be located in either Rockville, MD or Princeton, NJ

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho - the achievement, completion, and discovery of truth; and Sozosei - pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.

Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

Global Program Head, Policy, Learning and Engagement

This role supports the Global CECO and wider Global Ethics & Compliance team and will be responsible for defining global policies and procedures, creating global training program curricula and content and setting enterprise-wide compliance communication standards and approach.

**Please note that this position can be located in either Rockville, MD or Princeton, NJ


Responsibilities include but not limited to the following:
The major responsibility of this position is high-level oversight of engagement execution including ensuring standardization, reporting global compliance audit and monitoring results, as well as maintaining and further strengthening relationships with global business stakeholders

  • Working with senior leadership to identify strategic priorities for updates to global policies and SOPs and assuming a lead role in creating or updating these policies/SOPs
  • Developing a governance approach, workflow approval, and updating process for all global compliance policies and procedures
  • Creating and managing a global compliance training curriculum consistent with business needs and regulatory requirements, and performing annual reviews and updates of program to optimize training standards, types, volume, access and adherence and learning outcomes
  • Managing and building a collaborative network of relationships with regional leaders to identify areas of risk or compliance knowledge deficiency and develop training program solutions
  • Creating a global communications program and implementation approach to support Ethics & Compliance initiatives, creating necessary content and managing logistics and execution
  • Communicating proactively with senior Ethics & Compliance leaders about issues and progress relating to global policies, training and communication initiatives

Qualifications:

  • BA or BS Degree required, relevant advanced degree preferred
  • Proficiency in multiple languages desirable
  • Minimum 10 years of legal, compliance or commercial experience, preferably in the healthcare or pharmaceutical industry is required.
  • Strong understanding of US, EU and international pharmaceutical laws (including fraud and abuse, anti-kickback/anti-bribery, FCPA, FCA) and implications for business strategy is required.
  • History of successful individual contribution to writing policies, procedures, training and guidance documents required.
  • Deep knowledge of best-in-class training methodologies and ability to leverage technology to deliver professional learning programs required.
  • Experience creating and executing awareness and communications strategies and tactics required.
  • Ability to work and deliver on deadlines while managing multiple projects and priorities effectively
  • Experience working across geographies and cultures, with a variety of personalities and working styles
  • Strong verbal and written communications skills - candidate must be skilled and comfortable with presentations to executive management
  • Confident in exercising independent judgment and identifying when to involve other team members with relevant subject matter expertise
  • Up to 20% domestic and international travel is required based upon business needs.

 Apply here
Posted 1/18/2020

GLOBAL PROGRAM HEAD, COMPLIANCE AUDIT AND MONITORING - Otsuka Pharmaceuticals
Location: Can be located in either Rockville, MD or Princeton, NJ

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho - the achievement, completion, and discovery of truth; and Sozosei - pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.

Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

Global Program Head, Compliance Audit and Monitoring

This role supports the Global CECO and wider Global Ethics & Compliance team in the creation, coordination and management of a global compliance audit and monitoring plan across all Otsuka pharmaceutical businesses.

**Please note that this position can be located in either Rockville, MD or Princeton, NJ


Responsibilities include but not limited to the following:
The major responsibility of this position is high-level oversight of engagement execution including ensuring standardization, reporting global compliance audit and monitoring results, as well as maintaining and further strengthening relationships with global business stakeholders

  • Develop and implement new global practices and guidelines for compliance auditing and monitoring ensuring plans are risk-based and regionally appropriate for both the Global Ethics and Compliance and Global Privacy teams
  • Create a risk-based compliance audit and monitoring plan for internal organizations, including CSIRT, and vendors/ third parties/ CROs
  • Engage with executive level personnel on global compliance audit and monitoring planning and priorities
  • Act as global liaison between US, EU and Japan/OIAA compliance audit and monitoring leads and key stakeholders (e.g., Sales & Marketing, and Global Quality, Regulatory and Safety (GQRST) personnel etc.)
  • Coordinate global execution of compliance audit/monitoring plan through frequent interaction with regional compliance colleagues
  • Track status of audits and monitoring activities globally, including synthesizing key findings/issues
  • Present key global issues to global Ethics & Compliance leadership and gain consensus on path forward
  • Work closely with other key global functions (e.g., Human Resources, Finance, Legal) to coordinate consistent approach to follow-up activities globally

Qualifications:

  • BA or BS Degree required, relevant advanced degree preferred
  • Proficiency in multiple languages desirable
  • Certified Internal Auditor, Certified Public Accountant, or Certified Fraud Examiner designation preferred
  • Minimum 10 years of legal, compliance or commercial experience is required.
  • Minimum 5 years in the healthcare or pharmaceutical industry is preferred.
  • Proven track-record in planning and executing corporate compliance audits and monitoring activities for a multi-national company
  • History of successfully working across geographies and cultures and with a variety of personalities and working styles
  • Thorough knowledge of US, EU and international pharmaceutical laws (including fraud and abuse, anti-kickback/anti-bribery, FCPA, FCA) is required
  • Ability to work with ambiguity, and respond to a rapidly changing, highly innovative environment
  • History of success in working as an individual contributor while showing ability to organize projects and work responsibilities, prioritize, and meet deadlines
  • Strong verbal and written communications skills - candidate must be skilled and comfortable with presentations to executive management
  • Up to 20% domestic and international travel is required based upon business needs.

 Apply here
Posted 1/18/2020

GLOBAL PROGRAM DIRECTOR, RISK ASSESSMENT AND MANAGEMENT - Otsuka Pharmaceuticals
Location: Can be located in either US, Japan or Europe

At Otsuka, we defy limitation, so that others can too.

We have an unwavering belief in doing more. In transcending expectations. In going above and beyond-under any circumstances-for patients, families, providers, and for each other. It's this deep-rooted dedication that drives us to uncover answers to complex, underserved medical needs, so that patients can push past the limitations of their disease and achieve more than they thought was possible each and every day.

We believe that the bigger the challenge, the bigger the opportunity. We are doing everything in our power to live up to our mission of creating new products for better health worldwide in two important therapeutic categories: neuroscience and nephrology.

Our culture is rooted in our Japanese heritage and almost 100-year history. Otsuka-people live by the core principles of Jissho - the achievement, completion, and discovery of truth; and Sozosei - pursuing that which only Otsuka is capable of delivering. We approach our business and overcome challenges through perseverance, unconventional thinking and humility.

Learn more about Otsuka Pharmaceutical Company on its global website at http://www.otsuka.co.jp/en. Learn more about Otsuka in the U.S. at www.otsuka-us.com.

Global Program Director, Risk Assessment and Management

This role supports the Global CECO and wider Global Ethics & Compliance team and will be responsible for coordinating our global risk assessment function and managing the enterprise wide risk register, which is a key part of Otsuka's global compliance program.

**Please note that this position can be located in either US, Japan or Europe


Responsibilities include but not limited to the following:

  • Developing and implementing new global program for compliance risk assessment and management (including development of best practices and guidelines)
  • Supporting and coordinating compliance risk assessment efforts globally, leveraging in-country compliance professionals for information
  • Managing relevant third parties involved in conducting compliance risk assessments in specific regions
  • Providing expertise and assistance to regional compliance leads to operationalize global compliance risk assessment operations
  • Working with IT to establish appropriate technology platforms to support global compliance risk assessment efforts
  • Understanding in-country risk assessment efforts already in place within affiliates, and providing a connection, both as a liaison and from a technology perspective, for these local solutions to be rolled up into a global risk register
  • Assisting with the roll-out of global compliance risk assessment approaches and solutions to all regions and affiliates
  • Capturing and reporting metrics in a meaningful and engaging manner that helps the Global CECO and other senior leaders understand Otsuka's global compliance risk profile

Qualifications:

  • BA or BS Degree required, relevant advanced degree preferred
  • Proficiency in multiple languages desirable
  • Minimum 8 years working in a Compliance or Legal organization, and preferably in pharmaceutical/biotech industry is required.
  • Strong understanding of US, EU and international pharmaceutical laws (including fraud and abuse, anti-kickback/anti-bribery, FCPA, FCA) and implications for business strategy is required.
  • Strong verbal and written communications skills - candidate must be skilled and comfortable with presentations to executive management
  • Ability to work with a variety of personalities and working styles, including across geographies and cultures
  • Excellent analytical and problem-solving skills with keen attention to detail
  • Strong organizational and project management skills
  • Track record of successfully working as an individual contributor, independently setting direction and demonstrating initiative under conditions of ambiguity
  • Proficiency in Excel required (e.g., formulas, pivot charts, pivot tables, formatting, etc.)
  • Up to 20% domestic and international travel is required based upon business needs.

 Apply here
Posted 1/18/2020

COMPLIANCE OPERATIONS MANAGER - Incyte
Location: Wilmington, DE US

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)
The Compliance Operations Manager is responsible for managing various systems and operational aspects of Incyte's global Compliance program with an emphasis on Compliance training, communications, and policies. The position will be responsible for developing, documenting, and tracking training and education of employees and external third parties, planning and developing internal communication activities and maintaining and managing Incyte's corporate policies. Additional responsibilities include managing other Compliance systems used to track and document Incyte's Compliance activities and preparing various reports related to the Compliance department activities.


Essential Functions of the Job (Key responsibilities)

  • Assist with the development of live and module training and communications for Incyte's Compliance program.
  • Manage Incyte's corporate policy inventory and employee training matrix, including facilitating the appropriate review and approval process for new or revised policies. Assist with regularly assessing key policies and procedures to mitigate identified risks and to meet government, industry, and company compliance requirements.
  • Manage the learning and document management systems used for trainings and policies, including training launches, completion tracking, and appropriate document retention.
  • Manage other Compliance systems including the policy exception process, Compliance mailbox, conflict of interest log, and other systems that may be developed.
  • Routinely work with global and regional functions to coordinate and execute policy, training, and communication efforts. Work with translation vendors to translate materials as needed.
  • Maintain and update internal and external facing web platforms that support the Compliance function.
  • Assist with the preparation of readouts, slide decks and dashboards related to compliance operations and progress.
  • Contribute positively to a strong culture of compliance and ethics.

Qualifications (Minimal acceptable level of education, work experience, and competency)

  • Bachelor's degree preferred.
  • Minimum five years relevant experience with three + years of pharmaceutical company compliance experience preferred.
  • Working knowledge of laws, regulations, and industry guidance that affect the pharmaceutical industry including federal and state government price report laws, fraud and abuse and anti-kickback statues, OIG and PhRMA guidelines, state marketing compliance laws, the Foreign Corrupt Practices Act, the UK Bribery Act, and other anti-bribery laws preferred.
  • Ability to work in a fast-paced environment and to handle multiple complex and confidential tasks. Strong detail orientation and focus on quality work product.
  • Strong written, oral communication, interpersonal, and organization skills.
  • Self-motivated, solution-oriented and adaptable.
  • High level of professionalism, integrity and ability to maintain confidences while working with sensitive, confidential information.
  • Experience working with affiliates outside of the US a plus.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

 Apply here
Posted 1/16/2020

SR. MANAGER GLOBAL COMPLIANCE - Incyte
Location: Wilmington, DE US

Incyte is a biopharmaceutical company focused on the discovery, development, and commercialization of novel medicines to meet serious unmet medical needs in oncology and inflammation and autoimmunity. Incyte is committed to the rigorous pursuit of research and development excellence to improve the lives of patients, make a difference in health care, and build sustainable value.

The Company strives to discover and develop first-in-class and best-in-class medicines-advancing a diverse portfolio of large and small molecules.

Job Summary (Primary function)
This position will include management and support of Incyte's Global Corporate Compliance Program, with significant interaction with Incyte's US business, Global and Regional functions, Country Management and other departments. This position will work to continuously enhance Incyte's Compliance program through application of best practices in the life sciences Compliance space.


Essential Functions of the Job (Key responsibilities)

  • Support the development, enhancement and implementation of Incyte's Compliance program elements across regions and markets with a view toward global harmonization.
    • In collaboration with EU, US and other Regional and Country Compliance leads, contribute to development of global compliance annual plans and priorities based on risk assessments and other relevant inputs.
    • Draft, coordinate and help implement global, regional and/or local Compliance policies, SOPs and other Compliance tools and templates.
    • Support development and delivery of live and/or recorded compliance training.
    • Support global compliance efforts by participating in the design and development of compliance monitoring activities.
    • Conduct Compliance reviews of certain business activities, e.g. external funding requests.
    • Represent Compliance at key business meetings and industry events.
    • Provide ongoing support to general compliance projects and processes as necessary.
  • Support Incyte's global anti-bribery anti-corruption (ABAC) program including policy, training and process needs.
    • Manage and implement enhancements to Incyte's third party due diligence processes, including management of system, third party risk criteria, ordering and review of diligence, developing mitigation actions in collaboration with the business, and ongoing monitoring of higher risk third parties.
    • Work cross-functionally to support Incyte's efforts to continuously enhance third party man
  • Support development and implementation of new Compliance programs in new markets.
    • Assist in development and implementation of compliance plans for new affiliates and/or partners in new, global markets.
    • Provide guidance to new affiliates and/or partners, and integrate compliance controls into the scope of these businesses as applicable with a focus on global harmonization and "right sizing" the program.
  • Provide regular updates to Global, EU and US Compliance Leads, and provide input into quarterly Global & US Compliance Committee meetings and bi-annual Audit Committee meetings. Help prepare and deliver regular compliance program readouts, slide decks and dashboards.
  • Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the corporate-wide compliance program, including federal and state government price reporting laws, state and federal privacy laws including GDPR, fraud and abuse and anti-kickback statutes, OIG guidelines, industry codes in relevant markets including PhRMA, EFPIA and JPMA, US state marketing compliance laws, FCPA, UK Bribery Act and other anti-bribery laws.
  • Contribute positively to a strong culture of compliance and ethics.

Qualifications (Minimal acceptable level of education, work experience, and competency)

  • Bachelor's degree required.
  • Minimum of 7 years of compliance experience in the pharmaceutical and life sciences industry preferred.
  • Experience in the areas of global compliance best practices, including working in markets outside the United States.
  • Knowledge of and experience with laws, regulations, and industry guidance that affect the pharmaceutical industry.
  • Effective public speaking skills and an ability to communicate in both verbal and written form with multiple stakeholders within and outside the company.
  • Collaborative team player with ability to work effectively with cross functional teams and projects both within and outside of the Compliance function.
  • Strong problem solving, risk analysis, and project management skills.
  • Proficiency in Microsoft Office; experience in data analytics a plus.
  • Ability to effectively prioritize and work in a fast-paced environment and to handle multiple complex and confidential tasks.
  • Ability to travel domestically and internationally up to 25% of the year.

Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.

Incyte Corporation is committed to creating a diverse environment and is proud to be an equal opportunity employer.

 Apply here
Posted 1/16/2020

DIRECTOR, COMPLIANCE AUDITING & MONITORING - Jazz Pharmaceuticals
Location: Philadelphia, Pennsylvania
Country: United States
Category: Corporate
Type: Regular Full Time
Job ID: 4686

Overview:

Jazz Pharmaceuticals is an international biopharmaceutical company focused on improving patients' lives by identifying, developing and commercializing meaningful products that address unmet medical needs. We are continuing to expand our commercial product portfolio and our research and development pipeline in therapeutic areas that can leverage our unique expertise.

Our therapeutic areas of focus include sleep and hematology/oncology - areas in which we have a deep understanding of the patient journey and a suite of products and product candidates to address critical needs.

We are looking for the best and brightest talent to join our team. If you're looking to be a part of a company with an unwavering commitment to improving patients' lives and being a great place to work, we hope you'll explore our career openings and get to know Jazz Pharmaceuticals.

Responsibilities:
The Director, Compliance Monitoring & Auditing is responsible for preparing and managing a small team to execute against the Jazz Pharmaceuticals, Inc. (Jazz) annual compliance monitoring plan. This position will oversee and assist with Compliance monitoring and auditing activities including: the monitoring of field activities, monitoring of company records and programs, executing and managing Jazz's annual Risk Assessment and Mitigation Process (RAMP) program, and managing remediation activities related to compliance findings and allegations of non-compliance with Company policy. The position will also be responsible for identifying and implementing leading-edge technology to further automate monitoring activities and implement innovative dashboards and analytics.

Primary Responsibilities:

  • Develops and manages the timely and accurate execution of the annual compliance monitoring plan.
  • Oversees and conducts live field monitoring of Commercial and Medical Affairs activities.
  • Oversees and conducts transactional monitoring of records and systems including but not limited to: patient assistance programs, arrangements and interactions with Independent Charity PAPs, expense reporting, medical information requests, and consulting and advisory engagements.
  • Prepares and presents reports and dashboards to numerous audiences, including the Compliance Committee that summarize monitoring and auditing findings and remediation.
  • Prepares reports for Certifying Employees under Jazz's Corporate Integrity Agreement that provide regular updates related to monitoring activities, metrics, trends, and/or observations within their area(s) of authority.
  • Incorporates monitoring and audit findings and observations into regular policy and SOP updates, Compliance training, and related Compliance communications.
  • Manages Jazz's annual RAMP process and prioritizing monitoring activities and mitigation plans based on potential risks associated with Jazz's products and with applicable Federal health care program requirements.
  • Develops and implements strategies to address and mitigate identified risks.
  • Manages the remediation and corrective action process within Compliance.
  • Conducts ad-hoc monitoring and auditing as necessitated by investigations and Jazz's Corporate Integrity Agreement.
  • Identifies and implements analytics and innovative technology to expand and advance monitoring and reporting capabilities.
  • Contributes as needed to the preparation of Government reporting, including reports required by the Corporate Integrity Agreement, Open Payments, and state law monitoring and reporting.
  • Develops and maintains updated knowledge and understanding of Jazz's products, industry regulations and guidelines, and Company policies and standard operating procedures.

Required Knowledge, Skills, and Experience:

  • Minimum of 8 years of healthcare compliance monitoring or auditing experience with a pharmaceutical/biopharmaceutical company or within the life sciences industry is required.
  • Demonstrated knowledge and understanding of the Anti-Kickback Statute and False Claims Act, Food and Drug Administration (FDA) rules and regulations regarding the promotion of pharmaceuticals, HIPAA, Open Payments, and relevant industry guidance, specifically PhRMA Code on Interactions with Healthcare Professionals is required.
  • Experience managing employees
  • Experience working under a Corporate Integrity Agreement is preferred.
  • Ability to manage multiple projects to completion on-time, meeting internal and external deliverables with high degree of accuracy.
  • Ability to interact with Jazz employees at all levels of the organization.
  • Team player with strong interpersonal skills.
  • Strong oral and written communication skills.
  • Ability to work collaboratively and independently as the circumstances require.
  • Self-motivated and detail-oriented.
  • Highest level of ethics and personal integrity.
  • Position may be based in Philadelphia, PA or Palo Alto, CA.

Required/Preferred Education:

  • Bachelor's degree required
  • Description of Physical Demands
  • Position requires regular travel within the United States (estimated at ~20% per year);
  • Participation in ride-alongs with field employees: one full day to multiple consecutive days;
  • Travel to participate at promotional programs: one hour to full day of attendance;
  • Travel to participate at external Conference, Congresses, and Industry events for 1-4 day periods;
  • Travel to Palo Alto office if needed to meet with business colleagues.

Description of Work Environment:

  • Work indoors will be in a normal office environment with little exposure to excessive noise, dust, fumes, vibrations and temperature changes
  • Frequent computer use;
  • Responsibilities will require a work schedule that includes working outside of "normal" work hours while traveling in order to meet business demands;
  • Given the nature of work performed by the Compliance Department, the Director, Monitoring & Auditing may be asked to temporarily support other compliance related activities (e.g. CIA, compliance investigation(s), etc.) when necessary to meet a compliance obligation or firm [e.g. Government] deadline.

Jazz Pharmaceuticals is an equal opportunity/affirmative action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 1/2/2020

ASSISTANT DIRECTOR ETHICS AND COMPLIANCE, RESEARCH AND INNOVATION - Astellas
Location: Northbrook, IL


Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.

There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

Astellas is announcing an Assistant Director Ethics and Compliance, Research and Innovation opportunity in Northbrook, IL.

Purpose & Scope:
This position will provide compliance direction and support to Medical Affairs & Development (M&D), the departments supporting these functions and Astellas's global entities, affiliates and business partners. The individual will serve as a principle compliance resource for these clients, assist in the development and implementation of compliance strategies, tactics and materials, and will be responsible for providing direct support and advice to help clients adhere to the Company's highest ethics and compliance standards.

Essential Job Responsibilities:

  • Provide compliance support and serve as a resource to Medical Affairs & Development (M&D), the departments supporting these functions and Astellas' related entities, affiliates and business partners, with focus on compliance risk areas such as clinical research, scientific and medical publications, scientific meetings and other interactions and engagements with healthcare professionals (HCPs) and healthcare organizations (HCOs)
  • Proactively identify his/her clients' compliance needs and opportunities, respond to his/her client's compliance inquiries, provide timely and sound compliance advice and develop and implement solutions for meeting those needs and opportunities, collaborating where appropriate, with others within Ethics & Compliance.
  • Lead the compliance integration activities of new Astellas acquisitions to assimilate business practices and establish a culture of compliance
  • Conduct reviews and approvals of requests for meetings with HCPs and payments to HCPs and HCOs to ensure compliance, alignment and consistency with internal and external guidelines, policies and procedures.
  • Proactively identify client's compliance training and education needs, and participate in the development, implementation and delivery of innovative compliance training materials, communications, presentations, workshops and systems.
  • Conduct monitoring of Company events, programs and activities, such as interactions and meetings with HCPs, advisory boards, consultant meetings, symposium, Congresses, investigator meetings, and implement appropriate corrective action, where necessary.
  • Partner with Ethics & Compliance and Legal colleagues across regions to address issues and identify opportunities for collaboration, alignment, process improvement and best practice sharing.
  • Conduct needs assessments to identify compliance support needs and opportunities on a continuing basis, assist in identifying potential risk areas and assists in the development, execution and implementation of strategic and tactical plans to address identified risks and needs.
  • Contribute to the development and implementation of long-range strategic plans and initiatives to enhance compliance policies, processes and controls regionally and globally.
  • Collaborate with client management, Human Resources and Legal on compliance matters and investigations as appropriate to address specific compliance issues.
  • Other duties as assigned.

Quantitative Dimensions:

  • Establish a strong and visible compliance presence with the client's organizations.
  • Review materials and documentation related to engagements and meetings with HCPs and funding provided to HCOs
  • Conduct compliance training sessions for client groups/year
  • Conduct ongoing monitoring of documentation related to client activities, events and programs
  • Monitor live activities, events and programs/year

Organizational Context:
This position typically interacts with client employees through the President level globally, as well as those within other functions, such as Finance, Legal, Government Affairs and Human Resources.

Qualifications:

Required

  • BA/BS degree
  • 10+ years of related work experience
  • 5+ relevant pharmaceutical industry experience working within and/or directly supporting an R&D and Medical Affairs organization
  • Significant knowledge of and experience in industry compliance issues impacting R&D and Medical Affairs, both within the US and globally
  • Demonstrated team leadership skills and strategic focus required. Demonstrated ability to exercise independent judgment, effectively collaborate with multiple functional units, lead without authority, exercise tact and discretion in assessing compliance needs, and to respond timely and accurately to compliance inquiries.
  • Excellent oral and written communication, presentation, teaching and coaching skills required. Ability to effectively communicate compliance issues verbally and in writing in a clear and understandable manner. Demonstrated ability to inspire trust and confidence through effective communication and interpersonal skills.
  • Demonstrated ability to be proactive, identify and focus on critical priorities with little or no supervision, and manage multiple projects simultaneously.
  • Strong work ethic and ability to produce high quality work under deadline pressures.
  • Ability to travel within the US and internationally up to 25%

Preferred

  • Prior pharmaceutical compliance experience is preferred
  • Masters or other advanced degree preferred

 Apply here
Posted 12/27/2019

SENIOR MANAGER OF COMPLIANCE POSITION - UroGen Pharma, Inc.
Location: Princeton, NJ U.S.

Description
The Senior Manager of Compliance will report to UroGen's Associate General Counsel and will assist in the development, implementation and management of the company's compliance program with particular attention to the Sales, Marketing, Commercial, Market Access and Medical Affairs functions in the U.S.

Responsibilities:

  • Develop and deliver training and education to employees and contractors including the Sales, Marketing, Commercial, Market Access and Medical Affairs functions in accordance with industry standards and best practices
  • Develop and maintain a complete digital library of the company's compliance policies, procedures and training materials and records of training completion in accordance with industry standards and best practices
  • Develop and optimize a digital platform for the company's compliance training
  • Demonstrate a strong working knowledge of the federal and state laws, regulations, guidelines and industry standards that serve as the foundation for the company's compliance program, policies, procedures and training curricula
  • Guide and educate business partners on the company's compliance program, policies and procedures
  • Assist as needed with the management and upkeep of the company's compliance program including monitoring the compliance hotline, building internal awareness of the compliance function and whistleblower rights, building a culture of compliance, and developing compliance communications as needed
  • Assist with the development and execution of risk assessments and audit plans as needed
  • Prepare compliance reports and metrics as needed
  • Work on cross-functional teams as needed

Experience and Education:

  • 5+ years of compliance experience in the pharmaceutical/biotechnology industry
  • Substantial experience in the development and execution of compliance training and the overall management of compliance training in accordance with industry standards
  • Strong working knowledge of federal and state laws, regulations, guidelines and industry standards governing the pharmaceutical industry
  • Bachelor's degree required; M.S. or M.S.J. (Life Sciences Law) or equivalent preferred; J.D. attorneys will also be considered for the role
  • Certification in Healthcare Compliance or equivalent formal/rigorous training preferred

Skills and Training:

  • Experience with live training in individual, group and online settings
  • Shows interpersonal skills and the ability to communicate at all levels of fast-paced organization
  • Demonstrates ability to take initiative beyond direct responsibilities
  • Demonstrates professional and positive demeanor
  • Resolves conflicts in a constructive, professional manner
  • Works well on teams
  • Creative problem solver to support business goals
  • Well-organized, detail-oriented, and able to manage numerous projects and conflicting demands in a fast-paced environment
  • Shows high proficiency with computer systems and programs such as Microsoft Office, Word, Excel, PowerPoint, SharePoint, and DocuSign

Office Location:
400 Alexander Road, Princeton, NJ

Other
Occasional domestic travel required.

Interested applicants may apply on the UroGen website:  Apply here
Posted 12/24/2019

MANAGER, COMPLIANCE - Lundbeck
Location: Deerfield, Illinois, US

At Lundbeck, we are tirelessly dedicated to restoring brain health so every person can be their best. Headquartered in Copenhagen with a U.S. home office in Deerfield, Ill., Lundbeck is the only global pharmaceutical company focused solely on brain diseases. Our legacy in neuroscience goes back seven decades and we have a long heritage of innovation. Lundbeck has developed and commercialized some of the world's most widely prescribed therapies for psychiatric and neurological disorders. Today, we remain uncompromisingly committed to improving the quality of life for people impacted by brain disorders. Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep and productive pipeline, and we continue to bring forward symptomatic therapies to help people live better lives, while simultaneously pursuing disease-modifying treatments.

SUMMARY:
The Compliance Manager will have direct responsibility for and assist with the implementation of all elements of the Lundbeck North America Compliance Program, which are modeled after the seven elements of an effective compliance program. This role will work closely with key stakeholders and partner with lines of business (LOB) in support of Compliance and overall business objectives.

ESSENTIAL FUNCTIONS:

  • Policies, Procedures and Controls, including Code of Conduct: Responsible for ongoing maintenance and updates to steering documents, policies and procedures. Partners with LOB to assist with reviews, development and updating of directives, policies and procedures.
  • Training, Education and Communications: Lead the compliance training program in accordance with company directives, policies and procedures. Partners with global compliance and LOB to develop, maintain, and ensure appropriate training content, training matrices and training calendars. Deliver appropriate training content and coaching to ensure standards are clearly communicated to employees. Load content and assign, track, maintain and report on trainings related to company directives, policies and procedures. Conduct follow-up to ensure completion of required training. Provide support for compliance communications program.
  • Investigations: Conduct internal investigations relating to alleged compliance violations. Effectively manage all aspects of internal investigations, while ensuring legal compliance and managing risk. Partner with the Chief Compliance Officer (CCO) to recommend follow-up and appropriate action.
  • Monitoring and Auditing: Develop and oversee field force auditing and monitoring initiatives to ensure compliance with Lundbeck's policies and procedures involving speaker programs, advisory boards, sample compliance, and other business activities. Conduct field monitoring, data reviews and audits of key compliance risk areas, in accordance with the US monitoring program. Draft reports and identify appropriate follow-up. Assist with all auditing and monitoring programs and processes to ensure effectiveness of overall compliance program.
  • Assessments: Conduct assessments to determine effectiveness of Compliance trainings, education and other initiatives.
  • System Ownership: Serve as system owner for the electronic learning management system (LMS), compliance program management software, and electronic steering document management system (LuDo).
  • Third Party Management: Manage day to day vendor interactions including budget, SOWs, verifying vendor invoices, and processing for timely payment.
  • Advice, Guidance and Other Duties: Proactively provide day-to-day guidance to relevant business units on compliance matters. Help drive a compliant culture. Execute other duties as assigned by the CCO.

REQUIRED EDUCATION, EXPERIENCE and SKILLS:

  • Accredited Bachelor's degree.
  • 3+ years of Compliance-related experience in the pharmaceutical, biotech or medical device industry.
  • Understanding of FDA rules and regulations and Fraud and Abuse Laws, such as the Anti-Kickback Statute and the False Claims Act.
  • Ability to communicate effectively with individuals at all levels, internally and externally.
  • Experience in development of training and curriculum design, including delivery and implementation of training and workshops.
  • Ability to effectively collaborate and problem solve.
  • Proactive, self-starter with a strong sense of ownership and accountability.
  • Strong planning, analytical, organizational, and time management skills.
  • Strong attention to detail.
  • Ability to function in a fast-paced environment handling multiple tasks simultaneously.
  • Demonstrated proficiency with Microsoft Office suite, including Excel, Word, and PowerPoint; Internet, or other systems tracking software.

PREFERRED EDUCATION, EXPERIENCE AND SKILLS:

  • 3+ years Compliance-related experience in the pharmaceutical industry.
  • 3+ years' experience with buy-and-bill systems and reimbursement support programs
  • Hands on experience supporting a learning management system (Success Factors experience a plus).
  • Experience administering live web meetings and training sessions with WebEX, GoToMeeting/GoToWebinar, Lync, or other webinar software.
  • Experience writing quality system documents in a Document Management system (such as Documentum and QDMS).
  • Product or sales management experience.
  • Project management experience.
  • Advanced Excel skills.

TRAVEL:

  • Willingness/Ability to travel up to 15% domestically. International travel may be required.

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.
 Apply here
Posted 12/13/2019