R&D Partners
Senior Medical Writer Job at R&D Partners in San Francisco
R&D Partners, San Francisco, CA, US, 94199
R&D Partners is seeking to hire a Senior Medical Writer in the San Francisco Bay Area .
Base pay range $130,500.00/yr - $147,500.00/yr
Location San Francisco Bay Area
Employment type Full-time
Seniority level Mid-Senior level
Job function Project Management and Strategy/Planning
Responsibilities Senior Medical Writer responsibilities:
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 Investigators 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.
Apply advanced documentation preparation and 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.
Qualifications Bachelors or higher degree; scientific focus preferred.
6+ years of medical writing experience within the pharmaceutical industry.
Experience with drug development process, clinical study protocol design, study conduct, and documentation required for the conduct of clinical studies.
Experience writing, reviewing, or editing INDs and BLA/NDAs highly preferred.
Benefits Medical insurance PPO, HMO & HSA
401k plan
Employee Assistance Program
Long?term disability
Weekly payroll
Online timecard approval
Salary range $130,500 to $147,500 (dependent on experience)
R&D Partners is an equal?opportunity employer.
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