Senior Medical Writer Job at R&D Partners in San Francisco

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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