For information about placing your employment listing on this page, contact Joe Braden at info@PharmaComplianceForum.org.
Cost is complimentary for PCF Members and $600 for 90 days for non members.
EMPLOYMENT OPPORTUNITIES
ASSOCIATE DIRECTOR/ DIRECTOR OF AUDIT - Novartis Pharmaceuticals Corporation
Under indirect supervision, performs complex compliance audits and monitoring, and supports assists in corrective training and/or other tasks to remedy issues uncovered.
- Develops on an annual basis, in coordination with other NPC Departments and Corporate Internal Audit, as appropriate, a risk-based assessment of Company operations and controls as they relate to Compliance with internal guidelines, SOPs, and processes. During the risk assessment stage, may meet with Directors or other senior managers of key areas to get their perspective on operations to perform initial assessment of compliance risks within individual functional areas.
- Schedule and plan audits in conjunction with the Corporate Compliance Officer; ensure all appropriate areas of Company's business are covered on a regular cyclical basis in accordance with internal risk assessment.
- Perform internal audit tasks, including planning, design and preparation. Major responsibilities include: of work papers, reporting and verifying the accuracy of Company's records and control systems.
- Perform internal audits.
- Assist in training and creating training materials related to remedying violations found and filling gaps in learning and know-how to create a complete compliance program.
- Liaise with various departments regarding Company's policies and procedures; remain current with developments in auditing procedures; and changes in local, state and federal laws as applicable.
- Responsible for designing and performing or coordinating monitoring of certain activities as identified as appropriate for monitoring based on the risk assessment or factors.
Bachelor's degree, MBA preferred. At least 5 years broad public or internal audit experience at a major global firm or corporation. Knowledge of pharmaceutical industry critical.
Minimum five (5) years experience in a leadership capacity. Ability to assess the impact of compliance requirements on the current business environment.
To apply to this position please visit the following website:
www.novartis.com
Go to "Careers"
Job Search US
Search Openings
Type 41651BR in the JOB ID window and this will bring you to the requisition
Posted 8/5/2008
Back to the top of page
HEALTHCARE LAW COMPLIANCE MANAGER - Alpharma
Alpharma - Growth Through Innovation
Are you looking for an opportunity where your talent and skills can make a real difference in people's lives? Somewhere you can take on challenges and enjoy levels of responsibility you would be hard pressed to experience at a larger pharmaceutical company? If so, then consider Alpharma.
Alpharma Inc. (NYSE:ALO) is a global specialty pharmaceutical company with a growing branded pharmaceutical franchise in the U.S. pain market. We are passionate about providing best-in-class customer service through innovative partnerships, technologies and processes. We are focused on seizing opportunities and delivering results. It's all part of our continuing commitment to Growth Through Innovation.
Our Pharmaceuticals Division is searching for a Healthcare Law Compliance Manager in Bridgewater, NJ who reports to Vice President & Sr. Counsel Healthcare Law Compliance.
The Manager, Healthcare Law Compliance will be a key member of the Pharmaceutical Compliance team by providing leadership and assistance with the development and execution of an effective, comprehensive compliance program for the sales, marketing, medical and home office teams. The role will include projects involving training, tracking, monitoring, reporting, investigating and other assignments as needed.
Oversee state law compliance by managing the process of reporting and/or monitoring company expenditures and other required data pursuant to state law reporting requirements by (a) compiling data from various company sources, analyzing the data, preparing and verifying the reports for internal review, submitting the reports, and documenting the submission of the reports; (b) analyzing new state law reporting and/or monitoring requirements; (c) developing solutions for satisfying such reporting requirements, and (d) managing database(s) containing information to be reported.
Manage Pharmaceutical Compliance Department Policies and SOPs in a document control database, including overseeing the posting of Policies, SOPs, Work Instructions, and forms on an intranet site. Assist in the development, drafting, and review of SOPs, Work Instructions, and forms that pertain to US healthcare law issues. Provide assistance to other departments in the development of SOPs that relate to healthcare law issues.
Engage in monitoring activities subject to the direction of the Vice President, Pharmaceutical Compliance.
Maintain and manage investigations database, including overseeing data entry, and runs reports and creates outputs from database. Provide assistance, as needed, to the Vice President, Pharmaceutical Compliance with investigations including but not limited to data collection and analysis.
Independently research, analyze, and complete special projects as directed under the guidance of the Vice President and Directors of the Pharmaceutical Compliance Department.
Requirements for the position include a Bachelor's degree, preferably in business, 3-5 years in a healthcare law compliance department in the pharmaceutical industry, Pharmaceutical policy and SOP creation/maintenance, internal monitoring experience, MS Office Suite, Lotus Notes and database management skills, excellent presentation skills and the ability to work in a team. Moderate travel will be necessary.
Alpharma offers a competitive salary and a comprehensive benefits package to all eligible employees, which includes a 401K match and tuition reimbursement.
For immediate consideration, please apply online or e-mail your resume with salary requirements to brandresumes@alpharma.com. Only candidates who include salary requirements will be considered.
Please reference NC-HLCM in the subject line.
EOE
Posted 7/30/2008
Back to the top of page
SR. DIRECTOR, COMMERCIAL COMPLIANCE - Amylin Pharmaceuticals
Reference #: PCF-04041
Amylin Pharmaceuticals, founded in 1987, is a growing biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Our Research and Development team has significant experience in metabolic diseases and is focused on investigating the biological actions and utilities of bioactive peptides and other compounds as potential drug candidates.
Amylin has amassed significant research and clinical expertise in metabolic medicine, including the areas of diabetes and obesity, and we're always looking for more talented and energetic professionals with not only the requisite knowledge & experience, but also the desire and passion to help us sustain our momentum and competitive edge.
Currently, we have a great opportunity for a highly motivated professional to lead and guide the commercial compliance team in the development, implementation, training, and enforcement of all applicable compliance programs. This includes programs to comply with OIG, PhRMA, PDMA, FDA, state reporting and other regulatory entities and regulations. The Sr. Director will also interface with the Corporate Compliance, Quality, and Regulatory teams as the commercial lead to ensure that a robust, effective, and consistent compliance program is built, implemented, and maintained.
Specifically, you will:
- Develop, advance and grow the commercial compliance team in order to update and build an effective commercial compliance program
- Collaborate with V.P. Commercial Operations & Strategic Relationship Management, Chief Compliance Officer, Corporate Compliance Committee, Commercial Leadership Team, and Commercial Compliance Committee to build and implement effective commercial compliance program
- Initiate and modify the company's commercial compliance policies, GPP's, and SOP's to ensure compliance and mitigate risk
- Assist with the identification of compliance matters that require follow-up or investigation and refer issues identified through Company audits to the appropriate internal investigation body
- Lead the commercial management response to internal and external audits including development and tracking
- Participate in the development and implementation of an effective training and education program on compliance-related topics, policies and procedures for the Company's commercial employees, focusing on the importance of controls, an effective control environment and the role of the internal audit and corporate compliance program
- Partners with internal business and department managers to increase awareness of the importance of the internal audit and corporate compliance program, including managers' reporting obligations under the program
- Participate on Corporate Compliance Committee and Commercial Compliance Committee
- Provide innovative solutions to cross functional technical issues, assuring that the solution falls within appropriate regulatory guidance
- Coach and mentor staff and prepare development plans and performance reviews for the compliance group
Requirements:
- A BA/BS in Business Management or Life Sciences
- 10+ years of compliance-related experience in the pharmaceutical/medical industry with an emphasis on commercial/sales
- 4+ years of experience managing a cross functional team
- Demonstrated knowledge and understanding of commercial compliance programs
- Excellent leadership, business judgement, conflict management, presentation, prioritization, and written/verbal communication skills
By "Challenging Science," Amylin challenges conventional thinking to create innovative approaches to the discovery, development and commercialization of novel therapies for metabolic diseases. Amylin's approach and dedication are rooted in the belief that we will be "Changing Lives" for millions of people. At Amylin, you'll have the chance to truly make a difference in people's lives. We also recognize top talent when we see it, and we reward it, generously, through our competitive compensation & benefits program. Amylin is proud to be an equal opportunity employer.
Click Here to Apply Online
http://careers.amylin.com/jobDetail.asp?id=13691&p=1
AMYLIN
Challenging Science. Changing Lives.
Posted 7/28/2008
Back to the top of page
ETHICS AND CORPORATE COMPLIANCE (MANAGER / DIRECTOR) - Endo Pharmaceuticals
Endo Pharmaceuticals is a ten year-old specialty pharmaceutical company of 1,200 plus employees with a history of exceptional growth and an established leadership in pain-management. Our product portfolio includes trusted brands like Percocet ®, and newer, innovative ones like Opana®, Frova®, and Lidoderm®. We have established research and development expertise in analgesics and devote significant resources to this effort so that we can maintain and develop our product pipeline, which includes several branded products in Phase III or Phase II clinical trials. Our culture is built on integrity, team-work, innovation, and resourcefulness, with a competitive compensation and benefits package that values each employee's contribution to the common goals. We are currently seeking a Manager / Director to join our Ethics and Corporate Compliance team at our Chadds Ford, PA Corporate Headquarters location. (Southwest of Philadelphia)
This position will be at the Manager or Director level, depending on the candidate's experience. Reporting to the Vice President, Ethics & Corporate Compliance, the Ethics & Corporate Compliance Manager/Director will provide leadership, advice and counsel on matters of compliance and ethical business practices. The, Ethics & Corporate Compliance Manager/Director will assist with the continued enhancement of the Ethics & Corporate Compliance Program by executing, through collaborative interactions, innovative strategies designed to assist the company in achieving its business objectives within the parameters of the law.
Key Responsibilities:
- Support and assist the Vice President, Ethics & Corporate Compliance in carrying out her role and responsibilities
- Develop compliance policies, procedures, and practices to be implemented across the organization
- Develop, implement, and coordinate education and training programs that focus on the elements of the corporate-wide compliance program, particularly related to key values, policies and procedures
- Audit and monitor adherence to compliance policies and procedures
- Coordinate and lead internal investigations
- Provide advice as it relates to compliance with applicable policies and procedures
- Maintain a current working knowledge of various laws, regulations, and industry guidance that impact the corporate-wide compliance program, including federal and state government price reporting laws, fraud and abuse and anti-kickback statutes, OIG and PhRMA guidelines, state marketing compliance laws, and the PDMA
- Increase awareness of the importance of the corporate-wide compliance program
Qualifications:
- Bachelor's degree required. Law degree strongly preferred.
- At least 1-3 years of pharmaceutical or health care compliance program experience as either a member of a corporate compliance team, consultant, or outside counsel.
- Proven track record in the areas of compliance policies, training, auditing, monitoring and investigations.
- Effective public speaking skills and an ability to communicate in both verbal and written form with employees throughout the company.
- Must possess excellent organizational and planning skills and the capacity to simultaneously handle a variety of complex confidential issues.
To learn more about Endo Pharmaceuticals please visit our website www.Endo.com. To apply for this role please reply to Peggy Royer-Parisi, Staffing Manager at royer-parisi.peggy@endo.com and include ECC in the subject line.
Endo Pharmaceuticals Inc. recognizes the advantages of a diverse workforce achieved through a commitment to equal employment opportunities.
Posted 7/25/2008
Back to the top of page
VICE PRESIDENT, CORPORATE COMPLIANCE - Leading Pharmaceutical Company
Reports to: President & CEO
Location: Midwest
Summary of Position
The Vice President of Corporate Compliance will lead, the development, implementation and oversight of the US Compliance Program to ensure compliance with federal and state health care program requirements. S/he will anticipate and influence the evolution of the compliance function supported by effective strategic, financial and human resource plans. The Vice President will be responsible for identifying and assessing areas of compliance risk and addressing these areas in the design of an overall Compliance program. S/he will lead a best-in-class compliance function by identifying training needs and training solutions which enhance corporate compliance; evaluating company policies, procedures and processes for compliance impact; assisting in investigating reported or identified compliance concerns; providing recommendations related to compliance specific issues; and addressing audit findings. The Vice President, Compliance will serve as a member of the senior management team in a highly-regarded, visible role within the global organization.
The Vice President, Compliance will ensure the continuing evolvement and improvement of the corporate compliance program by leading and defining (through internal and collaborative interactions) new, forward-thinking strategies based upon regulatory, industry and operational experiences.
Qualifications
- Bachelor's degree in Business, Economics or related field required. Advanced degree preferred. Law degree a plus with experience in health care law and specific knowledge of fraud and abuse and Medicare/Medicaid issues.
- 7+ years experience in the pharmaceutical industry in positions of progressive responsibility including 2+ years experience in business ethics/corporate compliance leadership role.
- Experience managing teams and in working with regulatory authorities and industry associations.
- Strong management, analytical, conflict resolution and group facilitation skills.
- Highly knowledgeable of the requirements for effective compliance programs and competitive landscape of industry programs in existence.
- Effective public speaking skills and an ability to communicate in both verbal and written form with a broad cross-section of management and employees throughout the company.
- Ability to present complex analytical information in a clear and concise manner to a variety of audiences and in understandable layman's terms.
- Expertise and connection to external environments and professional networks such as Pharmaceutical Research and Manufacturers of America (PhRMA) and the Health Care Compliance Association (HCCA).
- High level of ethical standards and proven track record in gaining and maintaining trust and credibility with internal and external constituents.
- Must possess excellent organizational and planning skills and the capacity to rapidly and simultaneously handle a variety of complex confidential issues.
- Experience in a multi-cultural setting would be highly desirable. Demonstrated ability to work effectively and congenially with employees at all levels within the organization.
- Demonstrated ability to exercise independent judgment and initiative.
- A driven, energetic individual with experience of operating within the professional standards of a large pharmaceutical company.
For additional information and consideration, please send resume to
Inquire@Koenig-Associates.com with the subject line: "VP Compliance."
Koenig & Associates, LLC, is a premier retained executive search firm specializing in the Life Sciences Industries. For additional information, please visit our website, www.Koenig-Associates.com.
Posted 6/18/2008
Back to the top of page
SENIOR BUSINESS ANALYST, GOVERNMENT PROGRAMS & CONTRACTS - Nycomed US Inc.
Location: Melville, NY
Summary
The Senior Business Analyst, Government Programs & Contracts reports to the Senior Director, Contracts & Logistics, with responsibility for ensuring contract compliance in accordance with laws and regulations, while representing the department as an expert in Government Programs and Contracts. This position will ensure continued compliance with Federal program regulations, and administer all relevant Federal programs. Additionally, shall be responsible for calculating and reviewing various government calculations prior to submission, which could include: ASP, AMP, URA, Best Price, NFAMP, Federal Ceiling Price, Federal Supply Schedule price, Industrial Funding Fee payments, Public Health Service Pricing, etc. This position shall act as point person for communications with government contracting officers at VA/DoD, and CMS, including the review of contracting proposals (solicitations, novations, and/or contract modifications) with appropriate government agencies (i.e. Federal Supply Schedule, PHS, 340B, etc.) prior to final approval by senior managers. This position will not have direct responsibility for administering Medicaid rebates or reporting AMP's, but should have a strong working knowledge of the related processes.
Essential Duties and Responsibilities include the following. Other duties may be assigned.
- Develop, analyze, review and collaborate where necessary, complex pricing, which might include: Non-Federal Average Manufacturer Price, Average Manufacturer Price, Best Price, Unit Rebate Amount, and/or Average Selling Price.
- Lead special strategic projects such as systems upgrades, standardization of reports, testing new calculations and executing price increases.
- Collaborate with Sales, Contracts and Finance teams to ensure proper management of various government programs & contracts, ie FSS, 340B, PHS, etc..
- Prepare accurate reports for senior management's review and/or approval; present reports and other contract information to senior management as requested.
- Respond to questions from within the Company regarding complex contract issues that require interpretation on a wide variety of issues related to policy, specific government agency, pricing, payment calculations, contract performance and compliance.
- Evaluate current processes and procedures and recommend improvements to enhance productivity. Document all processes & procedures.
- Develop/Enhance Standard Operating Procedures and templates to ensure standardization and effectiveness of business process.
- Collaborate with GPO and Trade team to determine appropriate pricing eligibility for new customers; identify government entities, class of trade, and appropriate contract pricing.
- Proactively seek out and comprehend complex information on changes in laws and regulations. Work with external experts to interpret the information and assess it's affect on government calculations. Develop appropriate response including changes in complex pricing strategies.
- Implement changes in complex pricing strategies and any other operating procedure or internal policy affecting Government Programs and Contracts.
- Partner with Finance to ensure accurate forecasting of Government calculations; provide necessary research and analyses.
- Participate in internal and external audits when needed in order to demonstrate compliance with policies, laws, and regulations.
- Attend Field and other company meetings, industry conferences, and customer meetings to stay current on the regulations, competitive environment, challenges and issues.
Supervisory Responsibilities
- May require supervision of junior financial analyst(s); requires ability to excel in a matrixed organization.
Qualifications
- Thorough knowledge of the different State and Government agencies that purchase products, understanding of their practices, policies, and guidelines.
- Thorough knowledge of current policies and guidelines including, VA, DoD, Medicare and Medicaid, that affect contracts, pricing, and rebates.
- Thorough knowledge of the various pricing calculations (e.g., Non-Federal Average Manufacturers Price, Average Manufacturers Price, Best Price, Unit Rebate Amount, Average Selling Price, 340B), and their effect on the Company's customers.
- Familiarly of the systems and reports that support government contracting, including Imany/CARS and CMED products, as well as SAP strongly preferred.
- Strong written and verbal communication skills. Demonstrated ability to prepare and deliver clear messages, present results of analytical evaluations, and make recommendations regarding such evaluations.
- Ability to write Standard Operating Procedures for Department and to train as needed or required.
- Strong interpersonal skills, ability to develop strong working relationships, and work collaboratively within a matrixed organization.
- Strong analytical and problem solving skills.
- Excellent and proven Excel and relational database skills.
- Ability to work independently on multiple projects, collaborating with multiple stakeholders to develop and execute tactics that best achieve goals within deadlines.
Education and/or Experience
- Bachelor's degree in Business, Finance, or Public Policy
- Minimum of six years professional industry experience including three years developing and administering government contracts for a pharmaceutical or biotechnology company
Language Skills
- Excellent verbal and written communication skills
Mathematical Skills
- Strong mathematical and/or statistical aptitude
Work Environment
- Office, some travel as needed.
Apply online at www.nycomedus.com!
EOE AA/M/F/D/V
Posted 5/29/2008
Back to the top of page
