ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following:• Develop and implement innovative regulatory strategies to ensure the company’s ability to optimize the commercial success of clients products through advertising and promotion within FDA- and corporate-defined boundaries. ...
The responsibilities of this job include, but are not limited to, the following:
• Develop and implement innovative regulatory strategies to ensure the company’s ability to optimize the commercial success of clients products through advertising and promotion within FDA- and corporate-defined boundaries.
• Avoid regulatory, legal and financial risks associated with advertising and promotion of clients prescription drug and medical device products by providing sound, well-reasoned regulatory advice to senior management.
• Serve as the Chair of the Copy Clearance Governance Committee (CCGC) to review and approval North America MRC and PRC policies and procedures and the resolution of escalated review items.
• Establish policies and SOPs that ensure the creation, review and approval of medical / scientific and promotional materials that comply with the company’s code of conduct and relevant external national / regional advertising & promotional regulations or codes of practice (e.g. ABPI Code of Practice, FDA regulations, TGA Therapeutic Goods Advertising Code) and are consistent with clients guiding principles
• As Chair of the CCGC, provide periodic updates to the Executive Committee on the performance of MRC and PRC, including resourcing and forecasting to ensure efficient and quality reviews
• Work closely with other functional areas of medical, legal and compliance in the review and approval of Business Needs Assessments related to external commercial and medical activities associated with KOL meetings, symposiums and market research.
• Contribute to the creation and implementation of strategies and practices that ensure the creation of quality promotional material • Influential regulatory representative to the Global Regulatory Affairs leadership team.
• Maintain US Regulatory budget by working with Finance to ensure that monetary control over spending is maintained on a monthly/annual basis
• Establish and nurture a collaborative and respected working relationship with the head of the Office of Prescription Drug Promotion at FDA that ensures expeditious consultation on matters that have the potential to affect promotion of client’s products.
• Ensure value-based processes are in place to prevent, detect and correct violation of clients MRC / PRC review and approval procedures and regulatory requirements.
• Ensure new information related to advertising and promotion of prescription drug products is analyzed and the impact communicated to the organization
• Ensure sound regulatory practices are fully integrated into training of all individuals involved in the creation, review and approval of promotional material for Clients.
• Attract, develop and retain a team of key regulatory professionals, recognized for their customer focus and regulatory and scientific acumen
• Provide leadership and direction that ensures staff will meet expected delivery targets
• Assist with other assignments or projects as assigned by the SVP, Global Regulatory Affairs
Education: Bachelor’s degree required, Master’s Degree, PharmD or PhD in a biomedical science preferred
• A minimum of 15 years of pharmaceutical industry experience required with 8 years in a Regulatory Affairs leadership role.
• Demonstrated track record of leading promotional copy review and approval team and working within a highly matrix organization.
• Demonstrate track record of successful interactions with OPDP staff and management
In addition to the minimum qualifications, the employee will demonstrate:
• Strategic thinking with a bias for strong results-orientation with a demonstrable track record of success
• Excellent interpersonal skills/leadership presence and ability to engage and influence internal and external stakeholders.
• Demonstrate high levels of energy and drive; ability to set and deliver challenging targets.
• Confidence to challenge the status quo, to speak up and to manage and deliver change.
• Self-motivated and highly flexible - Ability to multi-task in a fast-paced atmosphere with multiple/changing priorities
• Experience leading and developing/mentoring junior staff
• Excellent written and verbal communication skills
This client is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do.
• 3 weeks’ vacation plus floating holidays and sick leave
• 401(k) and Profit Sharing Plan- Company match of 75% on your first 6% of contributions discount and profit sharing contribution equal to 4% of your eligible pay
• U.S. Employee Stock Purchase Plan- 15% Discount
• Comprehensive Medical, Dental, Vision, Life and Disability coverage
• Health and Dependent Care Flex Spending options
• Adoption assistance
• Tuition reimbursement
• Voluntary benefits including Legal, Pet Insurance and Auto/Home coverage
• Gyms, fitness facilities and cell phone discounts
• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.
Phone : 44(0)203 327 3072