Are you looking for a patient-focused company that will inspire you and support your career? If so, be empowered to take charge of your future at Takeda. Join us as a Head of Advertising and Promotion Oncology in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As a Head working on the Global Regulatory Affairs Oncology team, you will be empowered to be the Takeda in-house Regulatory specialist with a focus on product and disease state communications, and a typical day will include:
- In-depth knowledge of applicable FDA Regulations, Guidance, and enforcement trends around the advertising and promotion of prescription drug products, understanding of Takeda business objectives, and direct communication with the Office of Prescription Drug Promotion (OPDP) as required.
- Focus on creative solutions, independent strategic decision-making and GRA Ad-Promo team leadership.
- Aligns with GRA Senior Leadership and ensures issues are escalated as needed.
- Responsible for demonstrating Takeda leadership behaviours.
- Oversight and leadership of GRA Ad-Promo team USRC activity
- Independent GRA Ad-Promo lead in one or more product US Review Committees (USRC).
- Provides strategic input regarding overall communication of disease information, product data and corporate messaging to support Takeda business across brands.
- Provide Regulatory perspective and strategic approaches to communications to payer and formulary committee member audiences with a clear understanding of the FDA Guidance to industry regarding communication of information consistent with FDA required labeling.
- Conducts in-depth risk assessment of product claims and messaging grounded in FDA Regulations, current guidance, and recent enforcement trends.
- Offers consistent and innovative Regulatory guidance regarding the advertising and promotional communications across brands.
- Responsible for providing promotional regulatory guidance for development of product labeling (e.g., US Prescribing Information and Patient Information) factoring in current FDA guidance and applying best practices across brand portfolio.
- Serve as Regulatory Affairs USRC/Executive Review Committee (ERC) for assigned products and ensure alignment with Senior Leadership in GRA.
- Lead FDA meeting preparation and interaction with the Office of Prescription Drug Promotion (OPDP).
- Mentor and provide guidance to junior regulatory personnel.
- Maintain strong level of competitive intelligence and provide strategic input to our business partners regarding industry trends.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- Advanced degree preferred, BS, BSc, BA accepted
- > 10 years of bio/pharmaceutical experience in Regulatory Affairs Advertising and Promotional communications
- In-depth understanding of FDA regulations, guidance and enforcement trends to provide GRA Ad-Promo team guidance and support
- Experience managing direct reports or multiple staff
- Application of broad Regulatory Affairs concepts and implications across organization.
- Manual dexterity required to operate office equipment (i.e. computers, phones, etc.).
- Carrying, handling and reaching for objects.
- Ability to sit or stand for long periods of time while traveling
- Willingness to travel to various meetings, including overnight trips.
- Requires approximately up to 10-30% travel.
WHAT TAKEDA CAN OFFER YOU:
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement
- Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
Empowering Our People to Shine
Learn more at takedajobs.com.
No Phone Calls or Recruiters Please.