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Senior Manager/Manager, Medical Review

Waltham, MA

Posted: 01/10/2023 Industry: Scientific and Life Sciences Job Number: 15208

Job Description

Connexion’s mission is to provide "best in class" services to job seekers. We strive to achieve excellence in job placement, staffing, and recruiting services while treating candidates with the professionalism and respect they deserve.

Title: Senior Manager/Manager, Medical Review
Hiring Organization: Connexion Systems & Engineering
  • Duration: TEMP  
  • Pay rate: $100-110/hr
  • Job Location: Waltham, MA
  • Job# 15208

Overview: Medical review, a key function within Global Medical Scientific Affairs (GMSA), is responsible for medical review and approval of promotional and medical materials across all marketed products and pipeline candidates.
We are seeking a Senior Manager/Manager, Global Medical Review to lead the review of promotional and medical materials across therapeutic areas. This individual will represent Global Medical and Scientific Affairs in review committees to ensure scientific balance and medical accuracy of materials and will work closely with Medical, Regulatory, and Legal functions. This individual will also support medical communications to create high-quality, fair-balanced, compliant medical communications.

Key Responsibilities:
• Provides medical oversight for scientific review and approval of promotional and medical materials in compliance with corporate standards and government/industry regulations
• Serves as a lead medical reviewer, ensuring best practices are executed to increase the quality and scientific rigor of all field commercial and medical materials
• Collaborates with medical leads to ensure promotional and non-promotional materials are aligned to medical strategy
• Serves as a subject matter expert, providing medical and scientific expertise to commercial teams to support promotional claims
• Advises cross-functional teams on how to best communicate the scientific/medical value of products to key internal and external audiences
• Demonstrates broad knowledge of therapeutic areas, product labeling, and regulatory guidance
• Ensures delivery of high-quality, fair-balanced, scientifically/clinically accurate medical communications deliverables in accordance with established timelines, compliance guidelines/policies, and budgets

Basic Qualifications:
• Doctoral degree (PharmD, PhD, or MD)
• Minimum 5 years in the pharmaceutical industry
• 4+ years’ experience in a medical review role including promotional medical review
• 2+ year experience in medical communications
• Working knowledge of FDA regulations relevant to drug promotion and dissemination of medical and product information
• Ability to effectively work in a multidisciplinary team and cultivate collaborative working relationships between Global Medical and Scientific Affairs and cross-functional team members
• Strong business acumen
• Excellent verbal and written communication skills
• Proven planning and organizational skills with experience managing multiple priorities; attention to detail and the ability to prioritize in a changing environment
• Clinical knowledge in Oncology, including Hematology/Oncology (preferred)


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