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 an Associate Director/Senior Manager Advertising and Promotion-Oncology in our Cambridge office.
Here, everyone matters and you will be a vital contributor to our inspiring, bold mission. As an Associate Director/Senior Manager working on the Global Regulatory Affairs Oncology team, you will be focus on product and disease state communications to external audiences, and a typical day will include:
- Takeda in-house Regulatory specialist with a focus on product and disease state communications to external audiences.
- Strong understanding of applicable FDA Regulations, Guidance, and enforcement trends around the advertising and promotion of prescription drug products (including those pertaining to communications to payer and formulary-decision maker audiences) and application to Takeda business objectives.
- Focus on creative solutions, independent strategic decision-making and product team leadership.
- Aligns with functional leadership and ensures issues are escalated as needed.
- Serve as the GRA Ad-Promo lead in US Review Committee (USRC) for one or more products (project-specific alignment with management/functional head needed).
- Work closely with GRA Ad-Promo head to provide strategic input regarding overall communication of disease information, product data and corporate messaging to support Takeda business.
- Understand and interpret scientific data as it relates to regulatory requirements and product claim support.
- Responsible for providing promotional regulatory guidance for development of product labeling (e.g., US Prescribing Information and Patient Information) factoring in current FDA guidance.
- Management oversight of FDA submissions, including major launch campaigns, to the Office of Prescription Drug Promotion (OPDP).
- Lead USRC/Executive Review Committee (ERC) review of advisory comments and propose Regulatory strategy for negotiation and implementation in consult with GRA Ad-Promo head.
- Provide regulatory support in FDA meeting preparation and interact with the review staff at the Office of Prescription Drug Promotion (OPDP). May interact with other levels as appropriate within OPDP. Assist and attend FDA meetings as required.
- 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.
- Understand broad concepts within regulatory affairs, implications across organization, and demonstrate increasing independence in this area.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
- BA, BS, BSc, or PharmD accepted, Regulatory certification or Advanced Degree preferred.
- > 6 years of direct bio/pharmaceutical experience in a related aspect of drug development (late staged preferred) or direct experience with advertising and promotion communications.
- In-depth understanding of FDA regulations, guidance and enforcement trends to provide Regulatory guidance as part of USRC.
- Ability to interpret complex scientific data as it relates to regulatory requirements for product or disease state communications.
- Understanding of scientific principles and regulatory/quality systems relevant to drug development.
- Understanding of broad concepts within regulatory affairs and implications across organization - Proactively identifies regulatory issues and offers creative solutions for team alignment.
- Effectively communicate in cross-functional setting, maintain focus and bring working teams together for common objectives.
- Experience with current social media platforms and available communication technology.
- 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.