Senior Medical Writer-REMOTE
Company: Biolink360
Location: San Francisco
Posted on: April 17, 2024
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Job Description:
Job Category: Research & Development
Reports to: VP of Clinical Development
Job Type: Full time
Contract or Direct Hire
Location: REMOTE Based
Pay Rate: Depends on Experience
Company Type: Pharma, 600 Employees globally with HQ in Boston.
Product Category: Diagnostic imaging agents, Oncology BiopharmaThe
person in this role will provide a wide range of medical writing
services for multiple ongoing R&D projects and programs. The
main areas of responsibility include:
--- Writes and edits pre-clinical and/or clinical reports,
summarizing data from pre-clinical and/or clinical studies.
--- Prepares clinical reports, summary documents, package inserts
and other documents that may be submitted to the Food and Drug
Administration and other regulatory agencies.
--- Prepares scientific manuscripts, abstracts and posters.
--- Supports clinical research associates and medical doctors in
clinical protocol development. Responsibilities --- Write and
prepare clinical and regulatory documents including complex
integrated clinical statistical reports, protocol synopses,
protocols, protocols amendments, informed consent, annual reports,
and investigators brochures.
--- Actively participate in multiple ongoing projects and, or
programs on clinical work teams that drive the pipeline products
through the regulatory process.
--- Lead the process of critical reviews of these documents and
incorporating multiple reviews into successive drafts.
--- Manage all medical writing activities associated with an
individual study or product, collaborating across matrixed
organizations. Coordinate and prioritize multiple projects in a
fast-paced environment, aligning work activities to meet multiple
competing project timelines.
--- Manage and coordinate work with external medical writing and
publication vendors.
--- Maintain current knowledge of and ensure all functional work
team activities are conducted in compliance with the full range of
related internal and external systems, technology, regulatory
requirements and related policies and procedures. Qualifications
--- BA/BS Degree in a scientific discipline
--- 4-6 years of biopharmaceutical industry experience including 3
years of clinical and regulatory writing, in all phases of
pre-clinical and clinical development and regulatory submissions
and approvals
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Keywords: Biolink360, San Francisco , Senior Medical Writer-REMOTE, Advertising , San Francisco, California
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