Job Description

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

What we are looking for in a Senior Medical Writer :

• 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

Why choose R&D Partners ?
As an employee, you have access to a comprehensive benefits package including:

• 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)

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.

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