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Senior Medical Writer Jobs (NOW HIRING)

CooperCompanies

Senior Medical Writer

Trumbull, CT · On-site

The Senior Medical Writer is responsible for developing, writing, and managing high-quality clinical and regulatory documents that support compliance and product lifecycle needs for global standards ...

Cooper Companies

Senior Medical Writer

Trumbull, CT · On-site

The Senior Medical Writer is responsible for developing, writing, and managing high-quality clinical and regulatory documents that support compliance and product lifecycle needs for global standards ...

ARTHREX

Senior Medical Writer (Remote)

OR · On-site +1

Senior Medical Writer (Remote) Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for a ...

Olema Oncology

Lead Senior Medical Writer

Boston, MA · On-site +1

$160K - $175K/yr

About the Role >>> Lead Senior Medical Writer As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific ...

Olema Oncology

Lead Senior Medical Writer

San Francisco, CA · On-site +1

$160K - $175K/yr

About the Role >>> Lead Senior Medical Writer As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific ...

Olema Oncology

Lead Senior Medical Writer

Boston, MA · On-site

About the Role >>> Lead Senior Medical Writer As the Lead Senior Medical Writer, reporting to the Director of Medical Writing, you will lead the development, and delivery of high-quality scientific ...

Precision Medicine Group

Senior Medical Writer

$100K - $151K/yr

The Senior Medical Writer (MW) will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning ...

Precision for Medicine

Senior Medical Writer

$100K - $151K/yr

The Senior Medical Writer (MW) will be responsible for leading the development of high-quality and on-time clinical study documents. Specific responsibilities include clinical document planning ...

IQVIA

Senior Medical Writer

Durham, NC

Performs Senior Review of straightforward medical writing deliverables. Negotiates timelines and discusses/resolves customer comments. Provides written and verbal feedback to junior staff, and to ...

IQVIA, Inc.

Senior Medical Writer

Durham, NC · On-site

Performs Senior Review of straightforward medical writing deliverables. Negotiates timelines and discusses/resolves customer comments. Provides written and verbal feedback to junior staff, and to ...

IQVIA

Senior Medical Writer

Durham, NC

Performs Senior Review of straightforward medical writing deliverables. Negotiates timelines and discusses/resolves customer comments. Provides written and verbal feedback to junior staff, and to ...

Syneoshealth

Sr. Medical Writer (Regulatory)

OR · Remote

Sr. Medical Writer (Regulatory) Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across ...

ProPharma Group

Senior Medical Writer

Charleston, WV · On-site

With minimal supervision, authors (writes/edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of ...

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Senior Medical Writer information

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$35K

$137.3K

$247.5K

How much do senior medical writer jobs pay per year?

As of Jun 13, 2026, the average yearly pay for senior medical writer in the United States is $137,286.00, according to ZipRecruiter salary data. Most workers in this role earn between $104,000.00 and $166,000.00 per year, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive in the Senior Medical Writer position, and why are they important?

To thrive as a Senior Medical Writer, you need advanced writing and editing skills, a thorough understanding of scientific and medical concepts, and typically a degree in a life science or related field. Familiarity with referencing tools (like EndNote), document management systems, and compliance with regulatory guidelines (such as ICH or FDA standards) is often required. Strong attention to detail, project management abilities, and the capacity to communicate complex ideas clearly are important soft skills for this position. These competencies ensure accurate, high-quality medical content that meets industry standards and supports effective communication among healthcare professionals and stakeholders.

What is a Senior Medical Writer job?

A Senior Medical Writer is responsible for creating clear, accurate, and compliant medical documents, including regulatory submissions, clinical study reports, and scientific publications. They work closely with cross-functional teams, such as medical affairs, regulatory affairs, and clinical teams, to ensure high-quality content. Senior Medical Writers also review and edit documents for consistency, clarity, and adherence to industry guidelines. Often, they mentor junior writers and contribute to process improvements within the medical writing team.

What are some of the common challenges faced by Senior Medical Writers, and how can they be addressed?

Senior Medical Writers often encounter challenges such as managing tight deadlines, interpreting complex scientific data, and ensuring adherence to strict regulatory requirements. To navigate these challenges, it's essential to have strong organizational skills, effective communication with project teams, and a solid grasp of industry guidelines. Many Senior Medical Writers find that staying current with new regulations, participating in ongoing professional development, and leveraging collaborative tools help streamline the workflow. By proactively addressing these challenges, writers can maintain accuracy and efficiency while contributing valuable expertise to cross-functional teams.

More about Senior Medical Writer jobs
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Senior Medical Writer jobs near you
Infographic showing various Senior Medical Writer job openings in the United States as of June 2026, with employment types broken down into 100% Full Time. Highlights an 87% Physical, 5% Hybrid, and 8% Remote job distribution, with an average salary of $137,286 per year, or $66 per hour.
Senior Medical Writer

Senior Medical Writer

BioMarin Pharmaceutical Inc.

Remote

Full-time

Posted 7 days ago

Job description

Description
Who We Are:
BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions.
Guided by our purpose to develop medicines that make a profound impact on people's lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions.
Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world.
About Worldwide Research and Development
From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.
ROLE:
The Senior Medical Writer applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications.
RESPONSIBILITIES:
  • Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
  • Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator's brochures and periodic safety reports (PBRERs, DSURs, etc.)
  • Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries).
  • Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
  • Represents Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams).
  • Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met.
  • Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
  • Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
  • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
  • Works effectively with cross-functional groups within BioMarin
  • Other tasks as assigned.

SCOPE:
  • This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals.
  • Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.

EXPERIENCE:
  • Up to 6 years of as a medical writer in the pharmaceutical industry - OR - at least 10 years of medical or scientific writing experience as a primary job responsibility.

1) Medical Writing:
  • Experience writing, reviewing, or editing protocols and clinical study reports required.
  • Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred.
  • Experience writing, reviewing, or editing regulatory briefing books preferred.
  • Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content.
  • Ability to interpret and create complex tabular and graphical clinical data presentations.
  • Advanced applied knowledge of basic clinical laboratory tests.
  • Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).
  • 2) Clinical Studies
  • Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets.
  • Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection.
  • Intermediate to advanced applied knowledge of:

o documentation required for the conduct of clinical studies
o protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)
o study results reporting
o integrated results reporting
  • Direct experience with documentation in all phases of drug development.
  • 3) Regulatory
  • Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).
  • Prior familiarity with standard eCTD IND/NDA work, including:

o Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format
o Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)
  • 4) Project Management
  • Capable of working on multiple tasks and shifting priorities.
  • Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.
  • Capable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross-functional conflicts.
  • Good conflict management skills.
  • Motivated and shows initiative.
  • Detail oriented.
  • 5) Communication
  • Capable of well organized, concise and clear written and verbal communication.
  • Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.
  • Effective at explaining writing principles to a varied audience both in individual and group settings; intermediate to advanced presentation skills.

EDUCATION:
  • Bachelor's or higher degree required; scientific focus desirable.
    • Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

COMPUTER SKILLS:
  • Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.
  • Experience using document management software (eg, LiveLink, SharePoint, Veeva)
  • Experienced with scanners, printers, and copiers.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.
Equal Opportunity Employer/Veterans/Disabled
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

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