Associate Director/Senior Manager Advertising and Promotion - Oncology
Company: Takeda Pharmaceuticals
Posted on: March 28, 2020
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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
* Understand broad concepts within regulatory affairs, implications
across organization, and demonstrate increasing independence in
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
* Ability to interpret complex scientific data as it relates to
regulatory requirements for product or disease state
* 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
* Effectively communicate in cross-functional setting, maintain
focus and bring working teams together for common objectives.
* Experience with current social media platforms and available
* 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
* Willingness to travel to various meetings, including overnight
* Requires approximately up to 10-30% travel.
WHAT TAKEDA CAN OFFER YOU:
* 401(k) with company match and Annual Retirement Contribution
* Tuition reimbursement
* Company match of charitable contributions
* Health & Wellness programs including onsite flu shots and health
* 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.
Keywords: Takeda Pharmaceuticals, Cambridge , Associate Director/Senior Manager Advertising and Promotion - Oncology, Executive , Cambridge, Massachusetts
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