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Associate Director, RA Ad/Promo

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Associate Director, RA Ad/Promo

  • Location:

    Boston, United States

  • Sector:

    Life Sciences

  • Contact:

    Christine Weigel

  • Job ref:

    503

  • Published:

    4 months ago

  • Expiry date:

    2020-11-23

The Associate Director, Regulatory Affairs will serve as the Regulatory Lead on relevant projects and represents MorphoSys US, Inc. as the regulatory contact with relevant divisions of FDA, specifically the Office of Prescription Drug Promotion (OPDP). This position reports to the VP, Head of Regulatory Affairs US and will be located in our Boston, MA office.

Responsibilities

  • As a member of the US Review Committee team, the Associate Director, Regulatory Affairs will be responsible for providing input and advice on the review of promotional materials for regulatory validity
  • Critically review and recommend changes to promotional materials/activities to ensure balance of messages, accuracy and appropriateness of content in materials/activities and regulatory adequacy in accordance with relevant guidelines and regulations
  • Proactively align and build strong relationships with key stakeholders including Commercial, Legal and Medical on issues or concerns and to provide regulatory advice to ensure materials are balanced and accurate
  • Determine acceptability of data/references used to support promotional claims and provide expert guidance and effective negotiation leading to resolution for the approval of materials
  • Ensure implementation of updates in the labeling and maintenance of the labeling documentation, drug listing and SPL
  • Participate in the approval of related artwork
  • Keep the organization up-to-date on US regulatory promotional environment (e.g., the issuance of new FDA regulations/guidelines, relevant FDA enforcement action and general awareness of industry practices, including those of competitors) and laws, regulations and policies enforced by the regulatory authorities as they relate to labeling, advertising and promotion of pharmaceuticals

Job Qualifications, Experience & Skills

Required:

  • Bachelor’s degree required; Advanced degree (e.g. PharmD, MS, PhD) preferred
  • 5+ years industry experience with at least 3 years focused on the regulatory review of advertising & promotion of prescription drug products
  • Subject matter expert on FDA requirements for pharmaceutical product promotion, advertising and labeling
  • Strong interpersonal skills and exceptional communication skills, both oral and written
  • Developed business acumen and ability to impact and influence senior level and key internal stakeholders
  • Innovative, analytical and problem-solving capabilities, anticipating and identifying regulatory risks and making recommendations to management for resolution, as appropriate
  • Strong leadership and organizational skills with demonstrated success in driving optimal business results
  • Knowledge of Regulatory requirements when marketing online (i.e. internet, social media and other tools is strongly preferred)
  • Proven ability to analyze and interpret efficacy and safety data
  • strong detail orientation and ability to multi-tasking
  • Ability to work effectively across functions
  • Creative, flexible team player with strategic thinking capabilities

Location

  • Boston, MA