Senior Director of Medical Writing

Company: PSG Global Solutions
Location: Cambridge
Posted on: March 28, 2020

Job Description:

The OpportunityWe're looking for a Senior Director of Medical Writing, working in the Pharmaceuticals & Medical Products industry in Cambridge, Massachusetts.

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• Leads, directs, and mentors the medical writing team.
• Ensures development and maintenance of SOPs related to the development of clinical regulatory documents.
• Establishes writing standards that include document templates and style guides compliant with regulatory agencies and writing standards in collaboration with clinical development teams.
• Establishes medical writing timelines and forecasts writing needs and ensures appropriate resources.
• Sets standards for process of document review, completion and approval, ensures adherence to regulatory requirements, standards, and consistent with America Medical Writing Standards or other writing standards, where applicable.
  
  
  Our ClientOur client is an award-winning clinical development company. Improving lives globally with 20+ years experience in clinical research and strategic resourcing. Elevating results with proven strategies, comprehensive solutions, and customized delivery models.
  
  Serving pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations.
  
  Strong relationships provide you connections and access to great opportunities. Industry expertise sets you up for success with helpful insights, career coaching, and professional training. Grow and learn while you put your skills to work.Experience Required for Your Success
  
  
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  • Bachelor's degree in a life sciences discipline required, Masters/PhD degree in a life sciences discipline preferred
  • A minimum of 15 years biopharmaceutical industry experience
  • Must have at least 10 years in technical writing with 5 years of experience in managing staff of medical writers and/or vendors in preparation of technical documents (e.g., CMC, nonclinical, clinical, regulatory, etc.) including publishing and submissions
  • Prior IND/NDA/BLA submission experience, including eCTD, is required
    
    
    DetailsWe are offering Competitive Compensation and Benefits.What Do You Think?Does your experience reflect what it takes to be successful in this role? Do the work and challenges get you excited about what's possible? Apply here.
    
    Not exactly? Join Our Talent Community, and we'll let you know of additional opportunities.

Keywords: PSG Global Solutions, Cambridge , Senior Director of Medical Writing, Healthcare , Cambridge, Massachusetts