Radius Health, Inc.

Director, Regulatory Affairs (Scientific Review)

US-PA-King of Prussia
2 weeks ago
Job ID
2017-1648
# of Openings
1
Category
Regulatory

Overview

We are Radius Health! A science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases.”

 

The Director, Scientific Review chairs the Scientific Review Committee (SRC) and conducts the regulatory review of the materials at the SRC for assigned products within the Radius Health portfolio. In this role you will work collaboratively across cross-functional teams (including Medical Affairs, Medical Information, Health Economics, Legal, Compliance, R&D) to help ensure non-promotional scientific materials are compliant with applicable regulations, guidelines, corporate policies and product development objectives.

Responsibilities

  • Chairs the SRC, providing regulatory leadership and oversight of the SRC and its related activities, working collaboratively with the cross-functional groups to ensure the SRC process is efficient and operating smoothly
  • Provides regulatory expertise and guidance within the collaborative, cross-functional SRC for the review of non-promotional scientific materials
  • Works collaboratively with the SRC to help ensure that the materials are non-promotional and compliant with applicable regulations, guidelines, and corporate polices
  • Helps identify and implement process improvements as needed for the collaborative, efficient review of non-promotional, scientific materials
  • Provides Regulatory review of publications, abstracts, posters, and presentations submitted to the publication committee, working collaboratively across the regulatory functions
  • Assists in the review of promotional materials as needed on the separate Promotional Review Committee
  • Participates in ongoing training of personnel on regulations related to scientific exchange, labeling, advertising, and promotion, as well as the SRC process
  • Maintains a continued awareness and understanding of the regulations, guidance documents, and enforcement actions with regards to scientific exchange and advertising/promotion of pharmaceutical products. Contributes to Radius’s Health interpretation of the regulations and helps to communicate these to the Radius business as needed

Qualifications

  • BA/BS Degree or equivalent, preferably in a health/life sciences or related field
  • Minimum of seven years of experience as a regulatory reviewer of nonpromotional (scientific exchange) and/or advertising and promotional materials within the pharmaceutical industry
  • Current knowledge of FDA and global regulations and their interpretation relevant to scientific exchange, prescription drug advertising, promotion, and labeling
  • Commercial launch experience preferred
  • Working knowledge of the drug development process, including labeling development process
  • Proven ability to prioritize and meet project deadlines
  • Ability to resolve conflict and interact effectively with management
  • Excellent verbal and written communication skills as well as strong interpersonal skills and tactful negotiation skills
  • Experience using an electronic review system (e.g. Veeva) for the review of nonpromotional and promotional materials preferred

Radius Health, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Radius Health, Inc. complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.

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