Manager, Medical Review
Cambridge, MA 
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Posted 12 days ago
Job Description
The Manager, Medical Reviewer provides operational oversight of medical materials review within the Medical Affairs function reporting to the Director of Global Medical Review. This individual works closely and effectively with key members of internal departments including Marketing, Legal/Compliance, Regulatory, Medical Affairs and Clinical Development to assure that all materials, both promotional and medical, meet the rigorous standards of scientific accuracy, objectivity, and fair balance. This person serves on cross functional teams, representing medical affairs.

Primary Responsibilities Include:

  • Provide timely, medically relevant, scientifically sound, and fair-balanced medical/scientific reviews of materials submitted to medical and promotional review.
  • Responsible for providing oversight of the review of promotional and medical materials for scientific/medical validity across Sarepta's Portfolio.
  • Represent medical affairs in global cross-functional team meetings.
  • Critically review and provide solutions to complex promotional and medical pieces to ensure balance of the messages, medical accuracy, and appropriateness of the content of the materials/activities in accordance to scientific communication and with relevant guidance across Sarepta.
  • Proactively cultivate and grow strong relationships with cross-functional leads and other stakeholders to provide medical guidance in the development of scientific materials and resolve issues or concerns in promotional and medical review.
  • Leverage defined metrics and other tools to improve team performance and ensure adequate resource allocation.
  • Determine acceptability of data/references used to support promotional claims and provide expert guidance as well as effective negotiation leading to resolution for approval of pieces.
  • Address any scientific decision support needs from inquiries coming into Sarepta.
  • Maintains in-depth understanding of the disease state, product, competitors, marketplace, related medical areas, and regulatory guidelines.
  • Participate in the creation of, and ensure adherence to, departmental and corporate policies and SOPs and constantly look for places where process improvements would enhance the workflow.
  • Support commercial planning and launch planning activities including training materials, and medical information to provide scientific and medical support for publications and presentations.
  • Monitor the medical literature for Sarepta product(s) and relevant competitor data; analyzes the information for accuracy and relevance and appropriately synthesizes the data for inclusion in materials under review.
  • Collaborate with commercial operations, marketing, and regulatory operations to support the creation and submission of marketing materials and documentation to regulatory agencies.
  • Collaborate with Global Medical Communications and Medical Information to align with scientific information, establishing consistent communication.
  • Assist in driving consistency in medical information and communications, establishing one medical voice internally and externally.
  • Participate in internal and external meetings (training, educational and others, including medical congresses) to remain current on ever changing regulations, relevant new medical/scientific information and commercial strategy.
  • Other related duties as needed.

Desired Education and Skills:

  • Advanced clinical/scientific degree: PharmD, PhD with 2+ years of experience, preferably in medical affairs.
  • Scientific expertise in rare disease and gene therapy a plus.
  • Prior knowledge of the medical review process, experience as a medical reviewer a plus.
  • Excellent interpersonal, written, and verbal communications skills are essential to establish cross functional relationships.
  • High degree of accuracy; eye for detail, fastidious.
  • Ability to effectively manage time while balancing numerous high priority projects with a sense of urgency.
  • Must be a strong team player and be willing to work in an environment where individual initiative and accountability to the team are required.
  • Self-motivated with exceptional follow through.
  • Demonstrates flexibility in response to changing needs and competing demands.
  • Recognized by former peers, colleagues, managers and direct reports for attributes congruent with Sarepta Values: patients first, unconventional thinking, bias to action, integrity and talent.

#LI-Remote

This position is remote. However, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.

Candidates must be authorized to work in the U.S.

Sarepta Therapeutics offers a competitive compensation and benefit package.

Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

 

Job Summary
Start Date
As soon as possible
Employment Term and Type
Regular, Full Time
Required Education
Doctorate
Required Experience
2+ years
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