Senior Medical Writer

Job Title: Contract Sr level Medical Writer
Location: Fully Remote
Employment Type:

Contract (6–12 months, with potential for extension)
Experience required:
Looking for at least 8+ years relevant experience in biopharma
Leading in the development of all clinical documents
Will be working on study protocols to start; this is their immediate need
Other needs will scale up from there as they do (IBs, CSRs, etc)
We are seeking an experienced

Sr level Medical Writer

to support clinical and regulatory writing projects during this exciting phase of growth. This role will work closely with cross-functional teams, including Clinical, Regulatory, and R&D.
Responsibilities

Author and revise key clinical and regulatory documents, including:

Clinical Study Protocols and Amendments
Clinical Study Reports (CSRs)
Regulatory submission documents (e.g., INDs, NDAs, and CTDs)

Collaborate with internal teams and external vendors to gather, organize, and interpret complex scientific data.
Ensure documents comply with company standards, regulatory guidelines (e.g., FDA, EMA, ICH), and submission timelines.
Provide strategic input on data presentation and messaging to ensure clarity and consistency.
Perform literature reviews to support document development and provide scientific insights.
Edit and format documents to ensure accuracy, consistency, and adherence to style guides.
Manage document workflows, version control, and timely submissions.
Qualifications

Advanced degree in Life Sciences (e.g., MS, PhD, PharmD) preferred; Bachelor’s degree with extensive experience will be considered.
Minimum 8+ years of medical writing experience in the biotech or pharmaceutical industry.
Strong knowledge of clinical research, drug development processes, and regulatory requirements.
Proven ability to write clear, concise, and scientifically accurate documents.
Exceptional project management and organizational skills with a high attention to detail.
Familiarity with electronic document management systems (e.g., Veeva Vault) is a plus.
Strong interpersonal skills with the ability to work independently and collaboratively in a fast‑paced environment.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.

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