Senior Manager, Lead Promotion & Labeling Operations, Regulatory Affairs

Location
Cambridge, MA, United States
Posted
Aug 12, 2019
Ref
R-03125
Hotbed
Genetown
Required Education
Bachelors Degree
Position Type
Full time
Ipsen Promotional Review committee (PRC) process and product cross-functional teams deliver tools that enable the company to educate and sell to customers. It is important that PRCs function to meet deadlines and adapt to unique marketplace challenges and a dynamic regulatory landscape inherent in prescription drug promotion.

The Senior Manager, Lead Promotion & Labeling Operations is responsible for promotional and medical review of assigned Ipsen products and maintenance and implementation of approved labeling into packaging and promotion. The individual in this role is accountable for submission of branded promotion to FDA and will be the primary contact for any communication with The Office of Prescription Drug Promotion (OPDP).

Responsibilities

Responsibilities will include, but are not limited to, the following:
  • Serve as the regulatory subject matter expert on FDA Advertising & Promotion regulation on the Promotional Review Committee (PRC) and the Medical Review Committee (MRC). Provide review/approval of promotional and medical materials for assigned products
  • Prepare promotional materials for submission to FDA and liaise with FDA as needed on promotional matters
  • Foster a business partnership between Regulatory and PRC partner functions in the review and approval of Ipsen advertising and promotional materials
  • Collaborate with Global Regulatory Affairs to align strategy to US Commercial Teams' strategic imperatives
  • Lead efforts of PRC associated with re-review and expiry of approved materials and implementation of revised product labels in promotional materials, revised promotional content including safety information and requisite training materials
  • Maintain and implement US Product Labeling. Perform quality check of product labeling utilizing DocuProof Software to ensure that it matches the version approved by FDA. Manage the development of the SPL version and posting on Daily Med by Reed Tech. Initiates implementation of labeling into packaging. Tracks all label changes in the labeling tracker


Education
  • Bachelors degree required ideally in a life science field
  • PharmD preferred


Experience
  • 4+years commercial regulatory affairs experience
  • Experienced with proofreading technical documents
  • Rare disease experience preferred


Core Competencies
  • Active listening skills and ability to probe for information
  • Excellent interpersonal skills; competent and concise oral communications and writing ability
  • Must be able to foster a team environment and collaborate cross functionally to establish high-performing PRC Teams
  • Basic knowledge of pharmaceutical promotional regulations and submission requirements
  • Exceptional attention to detail
  • Comply with processes/workflows, implement process improvements, & solve problems
  • Ability to conduct process training for internal employees and vendors


IPSEN is an equal opportunity employer that strictly prohibits unlawful discrimination. We recruit, employ, train, compensate, and promote without regard to an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.