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Medical Writer III

San Diego, CA 92130

Posted: 05/02/2025 Employment Type: Contract Industry: Medical Affairs Job Number: 12137 Pay Rate: $60.00 - $69.00 Remote Friendly: Remote

Job Description

Our client develops and commercializes therapies for hallucinations and delusions associated with Parkinson’s disease.


Position Summary:
  • The primary responsibilities of an Associate Director Medical Writer include, but are not limited to, leading key medical writing projects and activities across therapeutic areas and preparing (under minimal supervision) scientific and regulatory documents related to the clinical development of investigational and marketed drugs and biologics.
  • These types of scientific and regulatory documents can include clinical study reports (CSRs), subject narratives, clinical investigator brochures, protocols, briefing documents, and sections of Investigational New Drug Applications (INDs) and New Drug Applications (NDAs)/Biologics License Applications (BLAs) (i.e., integrated summaries of safety and efficacy, product labeling, and summaries and overviews of nonclinical and clinical information).
  • The Associate Director Medical Writer has a broad range of experience in pharmaceutical medical writing and clinical/pharmaceutical development and knowledge of current regulatory guidelines.

Primary Responsibilities:
  • Acts as medical writing point person for production of preclinical summaries, clinical summaries, pharmacokinetic reports, safety summaries, literature reviews, and other documents needed for regulatory submissions.
  • Participates in and contributes to the development of the submission communication strategy for a product.
  • Interprets and summarizes data from biostatistical summary tables and listings accurately, precisely, and concisely into narrative text.
  • Liaises with internal groups, i.e., Biostatistics, Data Management, Regulatory Affairs, Medical Affairs, Clinical Development, Clinical Operations and R&D Management to obtain necessary information and to ensure the timely implementation of activities related to the production of reports.
  • Interacts with and oversees, coordinates and reviews the work of other medical writers, including freelance/contract medical writers and agencies, with support from Director Medical Writing.
  • Fosters innovation and improvement related to medical writing processes and documents, with support from Director Medical Writing.
  • Other responsibilities as assigned.

Job Requirements

Scope:
  • Uses professional concepts and company objectives to resolve complex issues in creative and effective ways, exercising judgment in selecting methods, techniques and evaluation criteria for obtaining results.
  • Works on complex issues where analysis of situations or data requires an in-depth evaluation of variable factors.
  • Determines methods and procedures on new assignments.

Meet Your Recruiter

Melissa Politron
Recruiter

As a Compass Recruiter, Melissa "Mel" is excited about rediscovering her passion in helping candidates find opportunities that will excel their professional lives and improve their personal lives. She brings a deeply-rooted excitement to the team by understanding the people she works with and finding ways she can support them. Mel's connections with others inspires her to make a difference in the overall well being of her colleagues, candidates and clients alike. 

Outside of Compass, Mel enjoys cooking, dancing and being a mom to her three wonderful boys. She has an obsession with home organization and thoroughly enjoys solving other families' organizational needs. Mel is also very passionate about One Heart Source, a humanitarian organization that combats conditions such as poverty, diseases and illiteracy through education. She participated as a summer volunteer teacher in Tanzania and credits the organization for shaping her into the person she is today. 

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About San Diego, CA

Ready to embark on an exciting career journey in sunny Southern California? Explore our job opportunities in the thriving city of San Diego! Known for its stunning beaches, perfect weather, and vibrant culture, San Diego offers a unique combination of career growth and quality of life. With renowned attractions like Balboa Park, the San Diego Zoo, and the USS Midway Museum, along with a diverse culinary scene and a plethora of art galleries and theaters like the La Jolla Playhouse, there's always something new to experience. Whether you're a sports enthusiast looking to cheer for the Padres at Petco Park or seeking outdoor adventures at Torrey Pines State Natural Reserve, San Diego has something for everyone. Begin your job search today and discover why this picturesque city is the perfect place to elevate your career!