The Pharmaceutical Compliance Forum

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EMPLOYMENT OPPORTUNITIES

 

MANAGER, COMPLIANCE - Chiesi USA
Location: Cary, NC US


Company Mission:

  • We want to be recognized as an international group focused on research, able to develop and commercialize innovative therapeutic solutions to improve the quality of people's lives.
  • We intend to maintain a high-quality entrepreneurial team, characterized by a spirit of cooperation and self-confidence.
  • Our goal is to combine commitment to results with integrity while operating responsibly from both a social and environmental point of view.

Job Purpose: The Manager, Compliance, will be responsible for supporting ethics and compliance programs and ensuring compliance with Chiesi USA's standard operating procedures, corporate policies, guidelines, and procedures, and applicable federal and state laws.  Essential position duties and responsibilities include but are not limited to: policy writing and policy updates; oversight of Aggregate Spend Reporting; Third Party Vendor management; Compliance training initiatives; audit planning and audits.

General Function/Specific Responsibilities:

  • Update policies, procedures and training to ensure regulatory environment and changes
  • Develop appropriate policies, procedures and training to ensure commercial compliance readiness
  • Identify and implement process improvements and enhancements to the Compliance program
  • Develop appropriate compliance training courses for employees and related third parties
  • Perform compliance training at onboarding, annually, and periodically through live, remote, and electronic means
  • Respond to day-to-day compliance questions from the management of field-based employees in a timely fashion
  • Oversee the day-to-day compliance needs of the field-based employees
  • Oversee the federal and state aggregate spend filings
  • Perform investigations related to compliance-related matters
  • Manage third-party compliance vendor agreement renewals and purchase orders
  • Participate in screening process for healthcare related agreements and third-party entities
  • Ensure interactions with healthcare professionals, key opinion leaders, researchers, and patients are conducted in an ethical manner
  • Perform and/or participate in regular and ad hoc audits
  • Assist VP, Compliance, with annual audit plan
  • Assist VP, Compliance, on system implementations and changes
  • Provide general Compliance support of all the compliance units
  • Create monthly management reports for VP, Compliance, and Monthly Management report

Requirements for Position:

Education and Experience

  • Bachelor's degree required
  • Minimum of 3 years of corporate compliance experience, preferably in pharmaceuticals
  • Strong knowledge of applicable laws, rules, and regulations, including but not limited to, OIG, FDA, FCA, CMS, AKS
  • Auditing and monitoring experience required
  • Experience with federal and state aggregate spend reporting preferred
  • Outstanding skills and experience in writing and modifying compliance guidelines
  • People Management experience, preferred

Essential Skills and Abilities

  • Excellent written, oral, and verbal communication skills across various audience types
  • Demonstrated ability of energetic and contagious leadership related to compliance programsC
  • Ability to identify risk and determine risk mitigation pathways
  • Strong leadership skills
  • Detail-oriented
  • Ability to review and understand data for purposes of auditing and investigations
  • Ability to comprehend and work with complex business scenarios
  • Excellent planning, organization and prioritization skills
  • Highly proficient in Microsoft Office tools, specifically Outlook, Teams, Word, Excel and PowerPoint

Supervision:

Direct Reports: Yes
Direct Reports: N/A

Confidential Data: Yes

Working Conditions:

  • Clean, quiet and professional working environment
  • Computerized office conditions
  • Minimal travel required

 Apply here
Posted 5/19/2020

SENIOR COMPLIANCE OPERATIONS MANAGER - Exelixis
Location: Alameda, CA US
Salary Grade: 10
Divisions: General & Administrative
Job Code: 1405
Department: Healthcare Compliance
FLSA Status: Exempt
Reports To: SVP, Healthcare Compliance
Effective Date: April 2020


SUMMARY:
The Compliance Operations Senior Manager will be responsible for the development, implementation, and continuous improvement of healthcare compliance practices, systems, and processes, with an emphasis on business integrity, operational excellence, and practicality. One primary focus will be supporting Development on healthcare compliance, anti-bribery/anti-corruption, antitrust, publication, privacy and data management issues. As part of this support, this position will be responsible for evaluating materials submitted for review and approval, performing audits, and conducting training related to interactions with the healthcare community. Another responsibility will be management of the process for tracking and reporting HCP spend. Of similar priority will be supporting and enhancing the Company's healthcare compliance monitoring program. The essential business partners for this function are corresponding positions in Development, Medical Affairs, Commercial, QA, IT, and Finance.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Works on a range of departmental and/or strategic problems where analysis of situations or data requires critical thinking, an in-depth evaluation, and company knowledge of various factors. May also be required to manage external consultant engagements, when needed, including overall budgets, schedules, and performance standards.
  • Leads the ongoing fulfillment of the company's HCP spend tracking and reporting obligations under the ACA's Sunshine Act provisions and related state laws regulating HCP spend by drug manufacturers or requiring state tracking and reporting. Applies advanced technical expertise in this arena and supports goals with an understanding of priority and impact to the program, department and organization.
  • Support execution of the audit and monitoring program, including development of tools, performance standards, and completion of corrective action. In conducting compliance assessments, the team lead will need to be a strategic partner to R&D to ensure that the compliance program evolves as the company grows.
  • Acts as a consultant, reviewer and legal/compliance approver as needed, for business activities that involve Healthcare Compliance risks, and contributes to departmental process and organizational improvements and development, including management of the contract request process for HCP engagements. In addition, participates in reviews of requests for approval of Development activities.
  • Assists with the company's Healthcare Compliance continuous improvement initiatives, including but not limited to, partnering with Quality Assurance to develop processes and training related to healthcare compliance, corruption, antitrust, publication, privacy and data management risks. GxP experience is a plus.
  • Leverages data analytic skills to proactively address potential healthcare/FDA compliance issues to prevent or minimize compliance risk to the company. Works with internal stakeholders to achieve business goals within a compliance framework.
  • Participates in the investigation of complaints and alleged violations of rules, regulations, policies, procedures, and standards of conduct, and coordinates with management in developing/implementing corrective action plans and providing general guidance on such matters.
  • Regularly reviews reports of new compliance developments from governmental agencies such as the OIG and state agencies, including fraud alerts, special advisories or proposed rules and, in conjunction with the legal department, to ensure appropriate interpretation and training regarding such developments.

SUPERVISORY RESPONSIBILITIES:

  • None

EDUCATION/EXPERIENCE/SKILLS:
Education:

  • BS/BA degree in related discipline and eight years of related experience; or,
  • MS/MA degree in related discipline and six years of related experience; or,
  • Equivalent combination of education and/or experience.

Experience:

  • Specific expertise in the best practices of healthcare compliance and auditing. Finance audit experience is a plus.
  • Familiarity with the legal principles of FDA advertising and promotion regulations, the False Claims Act, Anti-Kickback Statute, OIG guidance, and the PhRMA Code required.
  • Experience with Polaris software and/or Tableau is a plus.

Knowledge/Skills/Abilities:

  • Excellent verbal and written communication skills, must be an effective communicator with strong interpersonal skills
  • Strong organizational (detail oriented), project management, and problem-solving skills
  • Ability to handle multiple tasks, prioritize appropriately and adapt quickly to new situations, and offer creative solutions to challenging problems
  • Must be responsible, conscientious, and professional
  • Ability to work under pressure to meet specific deadlines
  • Ability to work independently and also be a team player
  • Must be able to exercise common sense in carrying out tasks
  • Dedication to quality and the highest professional standards
  • Must be a self-starter and quick learner
  • Must have good judgment
  • Strong computer skills (e.g., Microsoft Office Suite (Word, Excel, PowerPoint, etc.), Visio, Internet)
  • Ability to travel

JOB COMPLEXITY:

  • Works on complex problems where analysis of situations or data requires an in-depth evaluation of various factors.
  • Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation of criteria for obtaining results.
  • Uses professional concepts and company policies and procedures to solve a wide range of difficult problems in imaginative and practical ways.
  • 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 4/22/2020

SR. DIRECTOR BUSINESS ETHICS U.S. - Ipsen
Location: Cambridge, MA


Company Profile
Ipsen is a dynamic and growing global specialty-driven biopharmaceutical company, focused on innovation and specialty care. At Ipsen, we've created a workplace that recognizes and promotes an entrepreneurial spirit in our employees, and are building a strong legacy of helping patients with difficult-to-treat diseases across oncology, neurosciences and rare diseases. We know we can only be better and smarter if we work diligently together as ONE Ipsen, across all functions and geographies. We strive to break down silos and empower teams to deliver effective therapeutic solutions through highly differentiated medicines for patients with unmet needs.

We take pride in our culture, which is rooted in collaboration, to deliver results for our core customer – the patient. This level of involvement by cross-functional teams promotes a strong sense of unity, and pulls together all colleagues locally and across our key geographies, which span 115 countries across North America, Europe and Asia. As a growing organization, Ipsen North America is comprised of our Cambridge, MA, Basking Ridge, NJ and Toronto, Canada locations, with employees supporting functions including Commercial Operations, R&D, Business Development and Technical Operations.

Our employees are the driving force behind our mission at Ipsen, and to sustain their passion and focus every day, we offer a wealth of fulfilling challenges and growth opportunities through unique leadership and training programs. At Ipsen, you will work alongside industry leaders and contribute within a fast-moving and truly game-changing global organization, recognized for its talent and patient solutions. At Ipsen, we're making hope a reality for the patients we serve.

Position Summary
The Senior Director, Business Ethics will support Ipsen's U.S. Business Ethics program and be responsible for assisting in the execution and continuous improvement of Ipsen's global business ethics program. The role will ensure compliance with Ipsen Global and local policies and all applicable standards, laws, and regulations, including, but not limited to the Food, Drug, and Cosmetic Act, U.S. Federal Anti-Kickback Statute, False Claims Act, Federal Physician Payments Sunshine Act (Open Payments), Foreign Corrupt Practices Act, and HIPAA.

The role will involve the management and execution of the various aspects of the U.S. Business Ethics program including but not limited to:

  • Policy and Procedural document maintenance and creation
  • Training and education creation and delivery
  • Internal monitoring development and execution
  • Supporting lines of communication with stakeholders
  • Enforcing standards through investigation and publicized guidelines
  • Assessing compliance risk and implementing mitigating/corrective actions

Essential Functions
Responsibilities:

  • Provide business ethics support and guidance to the U.S. Oncology, Neurology, and/or Rare Disease brand and field teams, U.S. Medical/HEOR, Value & Access, and Transparency teams.
  • Assist the VP Business Ethics NA to prepare the annual business ethics work plan based upon a comprehensive compliance risk assessment.
  • Provide support to enhance and develop Ipsen U.S. Business Ethics policies, standards and procedures; work with members of Ipsen's businesses to understand the policies, standards, and procedures and how to implement business initiatives within that context.
  • Develop and deliver business ethics training to Ipsen stakeholders based upon assessing internal and external environmental developments and risk areas.
  • Develop and execute monitoring activities related to Ipsen's businesses and help ensure compliance with applicable internal and external requirements, including the evaluation of business activities, their respective approval and documentation.
  • Support the business with the operational Fair Market Value (FMV) efforts in connection with the engagement of HCPs.
  • Maintain a current working knowledge of various laws, regulations, and industry guidance that affect the Global Business Ethics program, including: Federal Sunshine Act (Open Payments), State Laws (restrictions, licensures, and reporting), Industry Guidance (PhRMA Code), and Federal Regulations (Anti-Kickback Statute, FDCA, HIPAA, etc.)
  • Work with the VP Business Ethics NA to coordinate the development and implementation of Ipsen's internal business ethics processes to enhance and streamline policy, communications, auditing, risk assessment, monitoring and investigation activities with a view toward global harmonization, automation and reporting.
  • Work with the Business Ethics Global Investigations Director to investigate potential violations of U.S. policies, standards or procedures raised to Business Ethics.
  • Support and cascade Ipsen's (Global) Business Ethics Program within the U.S. and collaborate with the Global Business Ethics team on Global initiatives
  • Proactively identify potential areas of compliance vulnerability and risk.
  • Implement corrective/mitigation action plans and oversee operational risks.
  • Act confidentially with urgency and diligence when responding to alleged violations of company policy, rules, regulations, thoroughly evaluate and recommend the proper course of action.
  • Participate in applicable meetings that require Business Ethics to be present.

Travel: Approximately 25% domestic and international

Qualifications
Education and Experience:

  • Bachelor of Arts and/or Bachelor of Science mandatory
  • MBA, JD, or professional degree is preferred
  • Minimum of 7-10 years of healthcare compliance experience
  • Minimum of 5 years in-house experience with a biotech or pharmaceutical company
  • A demonstrated aptitude and knowledge of the life sciences business model and commercial organization.

Core Competencies (Specific knowledge, skills and abilities that enable an individual to effectively perform the job)

  • Demonstrated knowledge and understanding of the Food, Drug, and Cosmetic Act, U.S. Federal Anti-Kickback Statute, False Claims Act, Foreign Corrupt Practices Act, and HIPAA.
  • Demonstrated knowledge and experience with the Federal Physician Payments Sunshine Act (Open Payments) and State Laws (restrictions, licensures, and reporting)
  • Broad pharmaceutical compliance experience interacting with field teams (sales, educators), marketing brand teams, Medical Affairs/HEOR, and Market Access.
  • Highest personal integrity and ethics; exceptional sense of judgment and discretion.
  • Ability to handle highly confidential and sensitive information with discretion.
  • Business and project management experience highly preferred.
  • Demonstrated skills in managing tight deadlines and multiple priorities.
  • Ability to work independently.
  • Superior time management and prioritization skills.
  • Ability to see the bigger picture; well-organized and focused on results.
  • Strong interpersonal and communication skills for negotiating deliverable, timelines and effective collaboration.
  • Ability to build consensus and respectfully driven decision making while gaining agreement regardless of issue popularity.
  • Proven ability to thrive in a fast-paced, deadline-driven environment and to partner towards a common agreed upon goal.

The statements contained herein reflect general details as necessary to describe the principles functions for this job, the level of knowledge and skill typically required, and the scope of responsibility, but should not be considered an all-inclusive listing of work requirements. Individuals may perform other duties as assigned, including work in other functional areas to cover absences or relief, to equalize peak work periods or otherwise balance workload.

Ipsen Biopharmaceuticals, Inc. is an equal opportunity employer. We recruit, employ, train, compensate, and promote without regard to race, religion, creed, national origin, age, gender, sexual orientation, sexual identity, marital status, military or veteran status, disability, genetic information, or any other category protected by applicable federal, state or local law.

Ipsen Biopharmaceuticals, Inc. conducts background screening, reference checks, and drug testing as part of its pre-employment screening process. This description is not intended to be constructed as an exhaustive list of duties, responsibilities, or requirements for the position. This position may change or assume additional duties at any time. The employee may be requested to perform different or additional duties as assigned.

Note: This description is not intended to be construed as an exhaustive list of duties, responsibilities or requirement for the position. This position may change at any time and the employee may be requested to perform different or additional duties as assigned.

 Apply here
Posted 3/26/2020

ASSOCIATE DIRECTOR - COMPLIANCE MONITORING, AUDIT AND RISK MANAGEMENT - Jazz Pharmaceuticals
Location: May be based in Philadelphia, PA or Palo Alto, CA


Brief Description:
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.

The Associate Director, Compliance Monitoring, Audit & Risk Management is responsible for developing and executing against the Jazz Pharmaceuticals, Inc. (Jazz) annual compliance monitoring plan. This position will regularly monitor field activities, conduct monitoring and audits of company records and programs, execute against Jazz's Risk Assessment and Mitigation Process (RAMP) program, and have responsibility for remediation related to compliance findings and allegations of non-compliance with Company policy. The position will prepare dashboards, reports, and presentations summarizing monitoring and auditing findings and remediation for audiences ranging from Business Partners,Jazz Leadership and 3rd parties. Finally, the position will support efforts related to analytics and innovative approaches to monitoring.

Primary Responsibilities

  • Conducts live field monitoring of Commercial and Medical Affairs activities.
  • 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 reports, presentations, and dashboards for numerous audiences, including Jazz Leadership, that summarize monitoring and auditing findings and remediation.
  • Supports Jazz's RAMP process and prioritizes monitoring activities and mitigation plans based on potential risks associated with Jazz's products and with applicable Federal health care program requirements.
  • Manages the remediation and corrective action process for the Compliance team.
  • Conducts ad-hoc monitoring and auditing as necessitated by investigations and Jazz's Corporate Integrity Agreement.
  • Supports the development and enhancement of data analytics and use of innovative technology to expand and advance monitoring 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 7 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 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.

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, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 3/24/2020

SENIOR MANAGER, COMPLIANCE OPERATIONS - Jazz Pharmaceuticals
Location: May be based in Philadelphia, PA or Palo Alto, CA


Brief Description:
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.

The Senior Manager, Compliance Operations is a critical role responsible for managing the day-to-day operations of the Compliance Department. The role will collaborate with all members of the Department to ensure an integrated approach to Compliance. This position will manage tasks and milestones associated with the annual Compliance Work Plan, Jazz's Corporate Integrity Agreement and support additional projects that affect the success of the execution of the Compliance Department's strategic business priorities. The role will involve the management of a number of key Compliance activities and systems including Fair Market Value, the Compliance Department intranet site, and the Compliance Operations mailbox. Additional responsibilities may flow from changes in the external risk environment or new regulatory requirements. The successful candidate will develop and implement the overall project plans for these projects and assign tasks and monitor progress against those tasks, as well as prepare reports and give presentations to Compliance Department management, the Compliance Committee and the Board of Directors that discuss the status and progress of such projects.

Primary Responsibilities
The Senior Manager, Compliance Operations serves as the Compliance Program Manager, and is responsible for the day-to-day management of the operations of the Compliance Department and oversight of certain Compliance activities and projects as determined by the Chief Compliance Officer and the Deputy Chief Compliance Officer, including, but not limited to:

  • Tracks and reports on the status of Compliance Department activities against the annual Compliance Work Plan.
  • Manages project plans and provides direction to Compliance Department personnel to ensure that all key deliverables related to Jazz's Corporate Integrity Agreement are timely accomplished.
  • Oversees the Compliance Department budget, including the management of monthly accruals, forecasting expenditures, and establishing practices that promote and support responsible spending.
  • Oversees the engagement and management of suppliers engaged by or acting on behalf of the Compliance Department including processes related to contracting, vendor setup, invoicing, and project closure.
  • Manages Jazz's Fair Market Value process and periodic updates to Fair Market Value rate cards, processes, and systems.
  • Develops and implements efficient systems, processes, and technologies to enhance operational tasks.
  • Plans, sets the agenda, and tracks completion of action items for key Compliance Department meetings.
  • Manages the Compliance Department intranet website to ensure that content is up-to-date and easily accessible by Jazz employees.
  • Manages the Compliance Operations mailbox and triages all messages to ensure they are timely addressed, tracked, and trends identified for reporting purposes.
  • Assists the Deputy Chief Compliance Officer and the Chief Compliance Officer in the preparation of regular reports and presentations for Company Leadership, Jazz's Compliance Committee and the Board of Directors.
  • Assists with building internal awareness of the Compliance Department and accessibility to Compliance teams and resources.
  • Participates in other Compliance Department projects as determined by the Chief Compliance Officer or Deputy Chief Compliance Officer.

Required Knowledge, Skills, and Experience

  • Minimum of 5 years of healthcare compliance experience with a pharmaceutical/biopharmaceutical or life sciences company is required.
  • Familiarity with the Federal Anti-Kickback Statute and Federal Civil False Claims Act, Food and Drug Administration rules and regulations regarding the promotion of pharmaceuticals, Health Insurance Portability and Accountability Act, Open Payments, and relevant industry guidance, including the PhRMA Code on Interactions with Healthcare Professionals is required.
  • Strong interpersonal, strong oral and strong written communication skills are required.
  • Strong organizational skills including attention to detail are required.
  • Experience working under a Corporate Integrity Agreement is preferred.
  • Program Management experience; previous successful initiation, planning, design, execution, monitoring, controlling and closure of multiple projects is required.
  • Ability to develop and effectively implement a project plan and ensure adherence to schedules, work plans, budget and performance requirements is required.
  • Ability to prepare presentations for use at all levels of the Company is required.
  • Ability to think critically, strategically and to quickly analyze complex compliance circumstances and problems.
  • Ability to prioritize competing demands and manage a heavy workload.
  • Ability to manage external consultants and vendors engaged to assist in conducting compliance projects.
  • Ability to work collaboratively and independently as the circumstances require.
  • Position may be based in Philadelphia, PA or Palo Alto, CA.

Required/Preferred Education

  • Bachelor's degree required.

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, sexual orientation, gender-identity, national origin, disability status, protected veteran status, or any characteristic protected by law.

 Apply here
Posted 3/24/2020

DIRECTOR, SENIOR COMPLIANCE COUNSEL - Karyopharm Therapeutics
Location: Newton, MA


Role Overview:
Is your New Year's resolution to find a new professional challenge with a fun, high energy and patient-focused organization? Karyopharm Therapeutics is looking for an experienced attorney to join us as Director, Senior Compliance Counsel. This position will report to the Chief Compliance Officer, and will be located at our headquarters in Newton, MA.

The Director, Senior Compliance Counsel will serve as the legal reviewer for advertising and promotional materials as well as materials used by Medical Affairs. This role will serve as a legal subject matter expert across areas of healthcare regulatory law, product liability and privacy laws. Maintaining a focus on the external environment, the Director, Senior Compliance Counsel will track and communicate to the organization significant decisions, legislation and regulatory rulings that may affect the company.

Additionally, this role will serve as a compliance business partner, providing proactive compliance guidance and support across key functions within the business. This role will assist in the development and implementation of compliance training and initiatives. This role will have high visibility throughout the organization, supporting core business activities and cross functional teams as assigned. The successful candidate in this role will develop strong and positive working relationships with colleagues at all levels, particularly within the home office and field-based Commercial and Medical Affairs organizations. This role will also lead and support a variety of cross functional projects as assigned.

Role Responsibilities:

  • Legal Reviewer for Promotional Advertising Review Team
  • Legal Reviewer for Medical Materials Review Team
  • Legal advisor in areas of healthcare regulatory law, fraud and abuse laws, privacy laws and other areas as assigned.
  • Compliance business partner supporting key business functions
  • Cross functional project participation and/or leadership
  • Compliance program support (e.g. training, monitoring, policies)
  • Other tasks as assigned.

Role Qualifications:

  • Juris Doctorate Required
  • MA Bar admission or eligibility for in-house counsel admission
  • Advertising and promotional materials review experience required
  • 5-10 years legal experience in Pharmaceutical or Biotech industry experience preferred
  • Prior compliance experience preferred

 Apply here
Posted 3/11/2020