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R&D Partners

R&D Partners is hiring: Senior Medical Writer in California

R&D Partners, California, MO, United States, 65018

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Senior Medical Writer

Marin Metro Area, CA US

Job Type: Clinical
Job Number: JN -102025-33766
Region: Marin Metro Area

Job Description

R&D Partners is seeking to hire a Senior Medical Writer in the San Francisco Bay Area.

Your main responsibilities as a Senior Medical Writer:

Apply advanced documentation preparation and document project management skills to assist in the development, review, editing and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.

  • Draft and edit documents used in conducting and reporting the results of clinical studies including protocols, protocol amendments, and informed consent forms
  • Draft and edit documents used in reporting aggregate safety and efficacy information for a molecule including Investigator s brochures and periodic safety reports (PSURs, DSURs, etc.)
  • Manage study team participation in the preparation of documents including running meetings, managing timelines, and overseeing the document review and comment adjudication processes

Qualifications

  • Bachelor's or higher degree; scientific focus preferred
  • 6 plus years of medical writing experience within pharmaceutical industry
  • Experience with drug development process, clinical study protocol design and study conduct and documentation required for the conduct of clinical studies
  • Previous protocol development experience required
  • Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred

Benefits

  • Medical insurance PPO, HMO & HSA
  • Dental & Vision insurance
  • 401k plan
  • Employee Assistance Program
  • Long-term disability
  • Weekly payroll
  • Expense reimbursement
  • Online timecard approval

Salary

$130,500 to $147,500 (Dependent on Experience)

Equal Opportunity Employer

R&D Partners is an equal-opportunity employer.

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