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Nonclinical Medical Writer Jobs (NOW HIRING)

Veristat

The Principal Medical Writer independently plans and prepares a range of regulatory documents and ... writing experience or equivalent experience with nonclinical sections of the CTD such as: * 2.4 Non ...

Veristat

The Principal Medical Writer works under the direction of Medical Writing management and ... writing experience or equivalent experience with nonclinical sections of the CTD such as: * 2.4 Non ...

Iambic

Principal Medical Writer

San Diego, CA · On-site

$152K - $190K/yr

Independently lead cross-departmental document development by collaborating with the Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory teams * Represent medical writing on internal ...

New

Iambic Therapeutics, Inc

Principal Medical Writer

$152K - $190K/yr

Independently lead cross-departmental document development by collaborating with the Clinical, Nonclinical, Medical, Biostatistics, CMC, and Regulatory teams * Represent medical writing on internal ...

VIKING THERAPEUTICS INC

Medical Writer

San Diego, CA · On-site

The Medical Writer will develop clinical study protocols, clinical study reports (CSRs), investigator brochures (IBs), informed consent forms (ICFs), safety and periodic reports, and the clinical ...

Ambition 24Hours Inc

Senior Medical Writer

The Lakes, NV · Remote

$142K - $195K/yr

Strong expertise in clinical development, regulatory writing standards, and cross-functional ... Medical Writing ───── Requirements ───── Bachelor's degree or higher in a ...

Integrated Resources INC

Medical Writer

Raynham, MA · On-site

Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing. Position Title: Medical Writing Specialist Division: Strategic Medical Affairs Reports To: Medical Safety Project ...

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Nonclinical Medical Writer information

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How much do nonclinical medical writer jobs pay per hour?

As of Sep 14, 2026, the average hourly pay for nonclinical medical writer in the United States is $38.64, according to ZipRecruiter salary data. Most workers in this role earn between $26.20 and $48.80 per hour, depending on experience, location, and employer.

What is a nonclinical medical writer?

A Nonclinical Medical Writer is a professional who specializes in creating scientific documents related to preclinical studies, such as research conducted in laboratories or on animals before human clinical trials begin. They prepare documents like study protocols, reports, regulatory submissions, and summaries of nonclinical data for pharmaceutical or biotechnology companies. Their work ensures that complex scientific findings are clearly communicated to regulatory agencies, stakeholders, and other scientists. Nonclinical Medical Writers play a vital role in the drug development process by ensuring compliance with regulatory guidelines and facilitating the approval of new therapies.

What types of documents does a nonclinical medical writer typically prepare, and how do they collaborate with scientific teams?

Nonclinical Medical Writers are primarily responsible for drafting and editing documents such as study protocols, nonclinical study reports, Investigator’s Brochures, and regulatory submission materials that summarize preclinical data. They work closely with toxicologists, pharmacologists, and project managers to ensure scientific accuracy and regulatory compliance. Collaboration often involves reviewing raw study data, synthesizing findings, and participating in cross-functional meetings to align on messaging and document timelines. Clear communication and attention to detail are essential, as these documents support drug development and regulatory approval processes.

What are the key skills and qualifications needed to thrive as a nonclinical medical writer, and why are they important?

To thrive as a Nonclinical Medical Writer, you need a solid background in life sciences or related fields, often with an advanced degree, and strong scientific writing and data interpretation skills. Familiarity with regulatory guidelines (e.g., ICH, GLP), document management systems, and referencing tools like EndNote is typical for this role. Attention to detail, time management, and the ability to communicate complex information clearly are crucial soft skills. These competencies ensure accurate, compliant, and accessible documentation that supports drug development and regulatory submissions.

What is the difference between Nonclinical Medical Writer vs Clinical Medical Writer?

AspectNonclinical Medical WriterClinical Medical Writer
CredentialsTypically requires life sciences degree, writing experience, and industry knowledgeRequires similar credentials, often with clinical trial or regulatory experience
Work EnvironmentPharmaceutical, biotech, or CRO settings focusing on preclinical studiesRegulatory agencies, pharmaceutical companies, or CROs focusing on clinical trial documentation
Employer & Industry UsageUsed in drug development stages before human trialsUsed during clinical trial phases for regulatory submissions
Search & Comparison IntentOften compared for differences in focus and documentation typesCommonly contrasted with nonclinical roles for clarity on responsibilities

In summary, Nonclinical Medical Writers focus on preclinical research documentation, while Clinical Medical Writers specialize in clinical trial documentation. Both roles require similar qualifications but differ in their work environment and focus within the drug development process.

What are popular job titles related to Nonclinical Medical Writer jobs?

For Nonclinical Medical Writer jobs, the most frequently searched job titles are:

Infographic showing various Nonclinical Medical Writer job openings in the United States as of September 2026, with employment types broken down into 100% Full Time. Highlights an 47% In-person, and 53% Remote job distribution, with an average salary of $80,364 per year, or $38.6 per hour.

Principal Clinical Medical Writer

Remote

BioMarin Pharmaceutical Inc.
Biotechnology Research and Development • 1 - 5K employees
Learn more about BioMarin Pharmaceutical Inc.external

Full-time

Posted 4 days ago

BioMarin Pharmaceutical rating

7.8

Company rating: 7.8 out of 10

Based on 8 frontline employees who took The Breakroom Quiz

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 R&D 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 rare diseases.
SUMMARY DESCRIPTION:
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 Clinical 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. The Principal Clinical Medical Writer has functional oversight responsibilities for medical writing staff and for the medical writing requirements for clinical development programs, including authoring/editing documents.
RESPONSIBILITIES:
  • Oversight responsibilities for Medical Writing staff
  • Works with the Head of Medical Writing to establish and maintain timelines for program planning.
  • 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 (e.g. PBRERs, DSURs)
  • Drafts and edits documents used in the preparation of regulatory filings (e.g. briefing books, CTD Module 2/Module 5 clinical or integrated summaries).
  • Manages study team participation in the preparation of such documents, including scheduling and chairing meetings, developing and managing timelines, and managing the document review and comment adjudication processes
  • Represents CMW at cross-functional team meetings (e.g. study team, development team, other sub-teams).
  • Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
  • Adheres to departmental procedures and practices and technical and industry standards during all aspects of work.
  • Assists in developing and reviewing standard processes and templates within Clinical Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
  • Works effectively with cross-functional groups within BioMarin
  • Other tasks as assigned.

EXPERIENCE:
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.
  • Advanced applied knowledge of:
  • Documentation required for the conduct of clinical studies
  • Protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)
  • Study results reporting
  • Integrated results reporting
  • Management Experience:
  • Prior administrative and/or functional management experience as a manager of a medical writer team or department in a clinical development setting preferred but not required
  • Demonstrated leadership abilities.
  • Demonstrated ability to plan timelines and resources for multiple documentation projects with shifting priorities.
  • Experience with delegating and overseeing projects and tasks.

Medical Writing
  • Writing high-quality documents that support corporate goals and objectives.
  • Experience writing, reviewing, or editing protocols, clinical study reports, INDs, BLA/NDAs, periodic safety documents, and regulatory briefing books required.
  • 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.
  • Ability to interpret basic clinical laboratory tests.
  • Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug).

Regulatory
  • Ability to plan and manage development of the following documents in context of regulatory requirements and guidances, development program plans, and organizational business needs:
  • Standalone' regulatory documents (eg, protocols, investigator brochures, clinical study reports, IND annual reports)
  • Prior familiarity with standard eCTD IND/NDA work, including:
  • Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format
  • Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)
  • Support project teams by identifying and summarizing relevant regulations and guidelines, including differences between US and EMEA submissions and to provide recommendations for changes in documentation in response to new or modified regulations and guidances.

Project Management
  • Ability to plan, resource, and assign multiple simultaneous document development projects (standalone and complex dossiers) with shifting priorities.
  • Ability to keep CMW line management apprised of program document status, to anticipate potential issues within a program, and to raise those issues to CMW line management with proposed mitigations/solutions
  • Ability to support staff in renegotiating timelines during development as necessary.

Program Management
  • Capable of managing and maintaining multiple timelines governing multiple projects within a program.
  • Capable of performing resource assessments (short- and long-term) based on projected project needs within a program.
  • Capable of anticipating potential issues within a program and raising those issues to CMW line management with proposed mitigations/solutions.

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; basic presentation skills.

EDUCATION:
  • Masters (MS) or higher degree preferred; scientific focus desirable.
  • Evidence of medical writing career development desirable, e.g. European/American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association

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.
Ireland Safety Responsibility
Support the organisation's commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.

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