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Senior Medical Writer

Blue Bell, PA · On-site +1

Senior Medical Writer- ICON- Remote USA ICON is a global healthcare intelligence and clinical ... Collaborate with scientific and account management teams to meet timelines, communicate project ...

ICON

Senior Medical Writer

Blue Bell, PA · On-site

Senior Medical Writer- ICON- Remote USA ICON is a global healthcare intelligence and clinical ... Collaborate with scientific and account management teams to meet timelines, communicate project ...

Costello Medical

Senior Medical Writer

New York, NY · On-site

$90K - $100K/yr

Senior Medical Writers take a leading role across projects, providing strategic advice to clients, supervising the project team, and producing high-quality scientific content themselves. They ensure ...

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Sr Medical Writer

Reading, PA

Sr. Medical Writer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...

Costello Medical

Senior Medical Writer

Boston, MA · On-site

$90K - $100K/yr

Senior Medical Writers take a leading role across projects, providing strategic advice to clients, supervising the project team, and producing high-quality scientific content themselves. They ensure ...

Costello Medical

Senior Medical Writer

Boston, MA · Hybrid

$90K - $100K/yr

Senior Medical Writers take a leading role across projects, providing strategic advice to clients, supervising the project team, and producing high-quality scientific content themselves. They ensure ...

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Senior Medical Writer

Blue Bell, PA · On-site +1

Senior Medical Writer- ICON- Remote USA ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a ...

Icon plc

Sr. Medical Writer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...

ICON

Senior Medical Writer

Blue Bell, PA · On-site

Senior Medical Writer- ICON- Remote USA ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a ...

ApotheCom

Senior Medical Writer

Yardley, PA · On-site

Senior Medical Writer - Publications ApotheCom, an Inizio Medical company, is an exciting leader in ... Compensation $1-$1 USD Don't meet every job requirement? That's okay! Our company is dedicated to ...

ICON

Sr Medical Writer

Blue Bell, PA · On-site +1

Sr. Medical Writer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...

Icon plc

Sr. Medical Writer ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster. As a values-driven ...

ApotheCom

Senior Medical Writer

Yardley, PA · On-site +1

Senior Medical Writer - Publications ApotheCom, an Inizio Medical company, is an exciting leader in the field of medical communications. Drawn together from several backgrounds including the ...

Regeneron Pharmaceuticals

Senior Medical Writer

$128K - $210K/yr

We are seeking a Senior Medical Writer to join our Medical Writing team, supporting clinical document delivery across Global Development in a remote work mode. In this role, you will author clinical ...

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Senior Medical Writer

Ambition 24Hours Inc

The Lakes, NV • Remote

$142K - $195K/yr

Contractor

Re-posted 26 days ago

Job description

Senior Medical Writer – Full-Time Remote Opportunity

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Location: Fully Remote (U.S.)
Industry: Pharmaceutical / Biotechnology
Employment Type: Full-Time
Salary Range: $142,100 – $195,360 annually
Experience Level: Mid-Senior
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Job Overview
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We are seeking an experienced Senior Medical Writer to support clinical development and regulatory documentation activities within a leading biotechnology environment. This fully remote opportunity is ideal for a highly skilled clinical science writer with extensive experience authoring Clinical Study Reports (CSRs), protocols, and regulatory submission documents across Phase I–III studies.

The ideal candidate is a hands-on writer who spends the majority of their time authoring and developing scientific and regulatory documents rather than primarily editing or managing teams. Strong expertise in clinical development, regulatory writing standards, and cross-functional collaboration is essential.

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Key Responsibilities
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Author and edit clinical study documents including protocols, protocol amendments, informed consent forms, and Clinical Study Reports (CSRs)
Prepare regulatory submission documents including briefing books and eCTD summaries/modules
Draft aggregate safety and efficacy documents including DSURs, PBRERs, and Investigator Brochures
Manage document timelines, review cycles, and comment adjudication processes
Lead and facilitate document-related meetings with cross-functional study teams
Collaborate with clinical, biostatistics, regulatory, pharmacovigilance, and data management teams
Interpret and present complex clinical data in clear scientific narratives, tables, and graphics
Ensure all documentation complies with regulatory guidelines, industry standards, and internal style guides
Support process improvements, templates, and standard operating procedures within Medical Writing

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Requirements
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Bachelor’s degree or higher in a scientific discipline required
7–10+ years of medical writing experience within biotech, pharmaceutical, or CRO environments
Extensive experience authoring Clinical Study Reports (CSRs) and protocol amendments required
Experience with INDs, NDAs, BLAs, DSURs, PBRERs, and regulatory briefing books strongly preferred
Strong understanding of clinical development processes and regulatory requirements
Experience with eCTD submissions and Modules 2–5 preferred
Ability to interpret complex clinical and statistical data
Excellent scientific writing, communication, and organizational skills
Proficiency with Microsoft Office Suite, Adobe Acrobat, Veeva, SharePoint, or similar document management systems
Ability to manage multiple projects and work independently in a remote environment

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Ideal Candidate Profile
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Highly experienced clinical medical writer with strong Phase I–III study expertise
Focused primarily on authoring scientific and regulatory content rather than editing or project management
Demonstrated excellence in CSR development and clinical science documentation
Biotech or pharmaceutical industry background strongly preferred
CRO experience considered
Strong attention to detail with the ability to meet strict timelines and regulatory standards