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Medical Writing Jobs (NOW HIRING)

Genmab

Director, Medical Writing

Plainsboro, NJ

$198K - $297K/yr

The Director, Medical Writing is responsible for advancing the medical writing portfolio within the clinical and regulatory areas. This includes authoring and overseeing the authoring of clinical ...

SAB

Director, Medical Writing

Sioux Falls, SD · Remote

$190K - $230K/yr

The Director, Medical Writing - Biologics will provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting ...

Alnylam Pharmaceuticals

Director, Medical Writing

$196K - $265K/yr

Overview The Director, Medical Writing will provide Medical Writing leadership for drug development programs, collaborate with project teams on the strategy and development of clinical documents ...

Argenx

Director of Medical Writing

Managing focus o Manage (80%) medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents o Author ...

Aequor Technologies

Medical Writer

Princeton, NJ · On-site

Oversees and reviews medical writing deliverables assigned to contractors or other third party vendors. * Participates in Global Medical Writing initiatives on clinical development cross-functional ...

Argenx

Associate Director, Medical Writing

OR · Remote

$164K - $225K/yr

Manage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents * Collaborates with project ...

Argenx

Associate Director, Medical Writing

$164K - $225K/yr

Manage medical writers (in-house FTEs, contractors, and external vendors) who are individually contributing to the MW activities for a variety of regulatory documents * Collaborates with project ...

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How much do medical writing jobs pay per hour?

As of Jun 5, 2026, the average hourly pay for medical writing in the United States is $46.27, according to ZipRecruiter salary data. Most workers in this role earn between $33.65 and $56.01 per hour, depending on experience, location, and employer.

What is medical writing?

Medical writing is the process of creating scientific documents by specialized writers in the healthcare, pharmaceutical, or biotechnology industries. These documents can include clinical trial reports, regulatory submissions, research manuscripts, patient education materials, and more. Medical writers must accurately present complex medical information in a clear, concise, and compliant manner, often working closely with researchers, doctors, and regulatory professionals. The role requires a strong understanding of medical terminology, scientific research, and regulatory guidelines.

What is the difference between Medical Writing vs Medical Editing?

AspectMedical WritingMedical Editing
Required CredentialsTypically requires a background in life sciences, healthcare, or related fields; often a degree or certification in medical writingRequires strong knowledge of medical terminology and writing; often a background in healthcare, editing, or related fields
Work EnvironmentOften works independently or in teams, creating clinical documents, regulatory submissions, and educational materialsUsually works alongside writers, reviewing and refining medical documents for clarity, accuracy, and consistency
Employer & Industry UsageUsed in pharmaceutical, biotech, healthcare, and medical device industriesCommon in publishing, healthcare communications, and regulatory agencies

Medical Writing involves creating original medical content such as clinical study reports, regulatory documents, and educational materials. Medical Editing focuses on reviewing and refining these documents to ensure clarity, accuracy, and compliance. Both roles require strong medical knowledge, but Medical Writers produce content, while Medical Editors improve existing content.

What are the key skills and qualifications needed to thrive as a Medical Writer, and why are they important?

To thrive as a Medical Writer, you need strong scientific knowledge, excellent written communication skills, and typically a background in life sciences or healthcare. Familiarity with referencing software, regulatory guidelines, and document management systems is often required. Attention to detail, adaptability, and the ability to explain complex concepts clearly are valuable soft skills in this role. These abilities ensure the accurate and effective communication of medical information for regulatory, clinical, or educational purposes.

How does a medical writer typically collaborate with subject matter experts and regulatory teams during a project?

Medical writers regularly interact with subject matter experts (such as clinicians and researchers) to ensure scientific accuracy and clarity in documents like clinical study reports, publications, or regulatory submissions. They also work closely with regulatory teams to align content with current guidelines and submission requirements. This collaboration often involves attending meetings, managing document reviews, and incorporating diverse feedback to produce high-quality, compliant deliverables. Effective communication and project management skills are essential to coordinate these multi-disciplinary efforts and meet strict deadlines.

What Are Medical Writing Jobs?

Medical writing jobs work in health care and science communities to compose documents and articles. Those who have medical writing jobs may draft many different kinds of papers, such as educational or promotional literature, medical abstracts for textbooks, or research documents. Other medical writing jobs include ghost-writing for prominent scientists or physicians, journalistic writing for scientific magazines, or creating content for marketing materials. Regardless of what field you are in, to obtain medical writing jobs, you must be able to decipher and interpret complicated information and write in a manner that your audience understands. For example, you may use medical jargon in scientific journals, but medical writers typically use simpler language when writing for the general public.

More about Medical Writing jobs
What cities are hiring for Medical Writing jobs? Cities with the most Medical Writing job openings:
What are the most commonly searched types of Medical Writing jobs? The most popular types of Medical Writing jobs are:
What states have the most Medical Writing jobs? States with the most job openings for Medical Writing jobs include:
What job categories do people searching Medical Writing jobs look for? The top searched job categories for Medical Writing jobs are:
Medical Writing jobs near you
Infographic showing various Medical Writing job openings in the United States as of May 2026, with employment types broken down into 1% As Needed, 73% Full Time, 23% Part Time, 1% Temporary, and 2% Contract. Highlights an 83% Physical, 2% Hybrid, and 15% Remote job distribution, with an average salary of $96,235 per year, or $46.3 per hour.
Director, Medical Writing

Director, Medical Writing

SAb Biotherapeutics, Inc

Sioux Falls, SD • On-site, Remote

$190K - $230K/yr

Full-time

Posted 17 days ago

Job description

The Director, Medical Writing - Biologics will provide strategic and operational leadership for the preparation, development, and delivery of high-quality regulatory and clinical documents supporting the late-stage development and anticipated commercialization of SAB's lead biologic candidate, SAB-142, and broader pipeline programs. This role requires deep expertise in biologics regulatory writing, including leadership of Biologics License Applications (BLA), Marketing Authorization Applications (MAA), clinical study reports (CSRs), and global regulatory submissions to the FDA, EMA, and other international health authorities. The ideal candidate will bring extensive experience supporting late-phase biologics programs within agile biotech environments, with a demonstrated ability to drive submission readiness, support commercial launch planning, and partner cross-functionally to advance programs through regulatory approval and commercialization.
  • Lead cross-functional development of Integrated Summaries of Safety (ISS) and Integrated Summaries of Efficacy (ISE) to support global regulatory submissions and benefit-risk assessments.
  • Provide strategic leadership for submission readiness activities, including pre-BLA planning, regulatory milestone preparation, and inspection-ready documentation strategies.
  • Experience operating within lean, fast-paced biotech environments with high individual accountability and accelerated submission timelines.
Duties and Responsibilities (Include but are not limited to):
  • Lead medical writing activities for biologic products across clinical development and regulatory submission programs.
  • Author, review, and finalize high-quality regulatory documents including:
    • Biologics License Applications (BLA)
    • Supplemental BLAs (sBLA)
    • Integrated Summaries of Safety (ISS)
    • Integrated Summaries of Efficacy (ISE)
    • Marketing Authorization Applications (MAA)
    • Clinical Study Reports (CSRs)
    • Investigator Brochures (IBs)
    • Protocols and protocol amendments
    • Clinical summaries and overviews
    • FDA and EMA briefing documents
    • Responses to Health Authority questions
    • Advisory Committee briefing materials
    • Labeling negotiation and product information documents
    • Submission gap assessments and remediation documentation
    • Module 2 summaries and other CTD/eCTD components
  • Direct and execute end-to-end medical writing strategy for global biologics regulatory submissions, including BLA, MAA, and lifecycle management activities.
  • Influence and align cross-functional stakeholders across Clinical Development, Regulatory Affairs, Biostatistics, Clinical Operations, Pharmacovigilance, Translational Sciences, CMC, and Executive Leadership teams to ensure consistent regulatory strategy and messaging. Ensure documents comply with ICH, GCP, FDA, EMA, and other global regulatory guidelines.
  • Ensure consistency of scientific messaging, pooled data interpretation, and benefit-risk positioning across all submission components.
  • Manage timelines, resources, and deliverables for complex submission activities. Lead submission readiness tracking, document planning, and cross-functional coordination for major filing milestones and regulatory deliverables.
  • Drive consistency, quality, and strategic messaging across submission documents. Contribute to process improvements, document standards, templates, and medical writing best practices as SAB continues to scale.
  • Provide vendor oversight to third party medical writers. Manage medical writer(s) who may be hired as SAB moves closer to BLA filing.
  • Collaborate closely with Regulatory Operations and Publishing teams to ensure technically compliant, inspection-ready eCTD submissions across global regions. Actively participate in regulatory strategy discussions and provide writing expertise during agency interactions.
  • Support key regulatory interactions including pre-BLA meetings, late-cycle reviews, advisory committee preparation, and responses to agency information requests.
  • Support lifecycle management activities including supplemental filings, annual reports, post-marketing commitments, and safety update documentation.
  • Support due diligence activities for potential partnerships, licensing discussions, and investor-facing regulatory communications, as needed.
Supervisory Responsibilities:
This position does not have supervisory responsibilities at this time. Supervisory responsibilities may be added at a future date.
Education/Experience/Skills:
  • 10+ years of medical writing experience within the biotech or pharmaceutical industry required.
  • Advanced degree: PhD, PharmD, MD, MS, in Immunology or related discipline
  • Experience with successful FDA and EMA approvals for biologic products preferred but not required.
  • Significant and demonstrated experience supporting biologic drug development programs through medical writing activities.
  • Demonstrated hands-on experience authoring and leading BLA and MAA submissions is required. Demonstrated experience leading late-stage regulatory submission activities through filing, review, and approval phases is strongly preferred.
  • Experience supporting expedited regulatory pathways, including Fast Track, Breakthrough Therapy, Orphan Drug, RMAT, and Priority Review, preferred.
  • Proven experience in preparing and managing:
    • Clinical Study Reports (CSRs)
    • FDA regulatory dossier submissions
    • Global regulatory submissions for biologic products
    • Integrated summaries (ISS/ISE)
    • NDA/BLA submission readiness and governance activities
    • Advisory Committee preparation support
  • Strong knowledge of:
    • FDA and EMA regulatory requirements
    • ICH guidelines
    • CTD/eCTD structure and submission standards
    • Deep understanding of late-stage clinical development and commercialization transition activities for biologic products.
  • Demonstrated leadership and influence within cross-functional matrix organizations, including the ability to drive alignment across competing priorities in fast-paced biotech settings. Work on multiple complex projects simultaneously and provide quality work product within deadlines.
Preferred Leadership Competencies:
  • Strong regulatory judgment and ability to proactively identify submission risks and mitigation strategies.
  • Ability to synthesize complex scientific and clinical data into clear, concise, and strategically aligned regulatory narratives.
  • Experience operating successfully in lean biotech organizations with evolving priorities and compressed timelines.
  • High degree of ownership, accountability, and execution focus.
  • Excellent written scientific writing, editing, and communication skills. Ability to verbally articulate scientific and related information to wider groups and stakeholders.
Physical Demands:
While performing the duties of this job, the employee is regularly required to walk, stand, and sit. The employee must regularly lift and/or move up to 10 pounds.
Working Environment and Travel:
Home office working environment.
Occasional business related travel is expected.
ADA:
The employer will make reasonable accommodations in compliance with the Americans with Disabilities Act of 1990.
This job description will be reviewed periodically as duties and responsibilities change with business necessity. Primary and additional duties and responsibilities are subject to modification.
SAB BIO is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. SAB BIO is committed to the principle of equal employment opportunity for all employees and does not discriminate based on race, religion, color, sex, gender identify, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other legally protected status. EOE/AA/Vets

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