102 regulatory writer jobs at 69 companies in United States
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Senior Regulatory Writer (Temporary)
United States
$130-$170/hrRemoteContract, Temporary
Vir BiotechnologyNASDAQ: VIR: Developing medicines for infectious diseases and cancer.
8+ YOEBachelor's degree and 7–10+ years industry experience, at least 8 years as a regulatory writer; experience preparing CSRs, IBs, protocols, IND/NDA/MAA submissions; expert knowledge of eCTD, ICH guidelines, and GxPs; strong writing and cross-functional collaboration skills.
Syneos Health: Global biopharmaceutical services for clinical development and commercialization.
Regulatory medical writer with expertise in clinical and regulatory documents (protocols, CSRs, IND/NDA/eCTD submissions), adherence to ICH E3 and client templates, document review, and mentoring; minimal travel (<25%).
Ora: Conducts clinical research for ophthalmic drug and device development.
1+ YOEMaster's in applied/life science or communications required; 1+ year medical/regulatory/clinical writing experience; ability to author and edit FDA and ex-US regulatory submissions (eCTD), interpret clinical data, and manage timelines.
Senior Regulatory Medical Writer, Client-embedded, FSP
Framingham or United States
$110k-$125k/yrRemoteFull Time
Thermo Fisher ScientificNYSE: TMO: Sells equipment and chemicals for scientific research and healthcare.
5+ YOEUS-based senior medical writer with 5+ years authoring clinical/regulatory documents; bachelor's in a scientific discipline required (advanced degree preferred); strong writing, project management, and regulatory knowledge.
Syneos Health: Clinical trial and commercialization services for biopharmaceutical firms.
Experienced medical writer for regulatory documents (protocols, CSRs, IND/NDA/eCTD, safety reports); knowledge of ICH guidelines, editorial review, literature searches, client interaction, and mentoring junior writers.
ImmunocoreNASDAQ: IMCR: Develops T cell receptor-based therapies for cancer and diseases.
3+ YOELead medical and regulatory writing for submissions from first‑in‑human through registration; strong writing track record, knowledge of global regulatory requirements, MS Word and Adobe Acrobat proficiency, experience with eDMS/RIMS and review systems; BS or advanced degree with relevant years of experience.
Curium: Manufacturer and distributor of diagnostic and therapeutic radiopharmaceuticals.
3+ YOECoordinate regulatory activities and submission content, track project deliverables, support regulatory submissions and electronic compilation; 3+ years regulatory and project management experience; bachelor\u0002s preferred; proficiency in Microsoft Project, Access, Excel and document management systems.
Microsoft Project, Microsoft Access, Microsoft Excel, Document Management Systems
Clinical Regulatory Writer, Associate Director / Manager
Gaithersburg, Maryland, United States
$133k-$200k/yrHybridFull Time
AstraZenecaLondon Stock Exchange: AZN: Researches, develops, and manufactures prescription medicines for major diseases.
2+ YOEBS in life sciences,2+ years medical writing experience in pharma/CRO (7+ yrs for Associate Director),knowledge of regulatory requirements,ability to lead authoring teams and author complex clinical-regulatory documents.
Clinical Regulatory Writer, Associate Director / Manager
Gaithersburg, Maryland, United States
$133k-$200k/yrHybridFull Time
AstraZenecaLondon Stock Exchange: AZN: Researches and develops medicines to treat major diseases globally.
2+ YOEBS in life sciences, medical writing experience (manager:2+ yrs; associate director:7+ yrs), ability to author complex clinical-regulatory documents, strategic communications and team leadership, knowledge of regulatory requirements.
Clinical Regulatory Writer, Associate Director / Manager
Gaithersburg, Maryland, United States
$133k-$200k/yrHybridFull Time
AstraZenecaLondon Stock Exchange: AZN: Global biopharmaceutical developing and manufacturing prescription medicines.
2+ YOEBS in life sciences required; 2–7+ years (manager) or 7+ years (associate director) medical writing experience in pharma/CRO; expertise in regulatory requirements, drug development, strategic communications, and leading authoring teams.
EXALTA: Designs and manufactures orthopedic medical devices and surgical instruments.
5+ YOE5+ years medical writing/regulatory affairs experience in medical devices; experience authoring CERs, PSURs, SSCPs; strong clinical appraisal and scientific writing; familiarity with EU MDR and relevant standards; MS Office proficiency.
Medical Writer - Clinical Regulatory Documentation
United States
OnsiteFull Time
Perspective TherapeuticsNYSE American: CATX: Develops targeted alpha-particle radiotherapies for cancer treatment.
5+ YOE5-8 years medical writing experience for sponsor/CRO preferred, oncology preferred; bachelor\u0002s in life sciences required; experience authoring clinical/regulatory documents and submissions; familiarity with FDA/EMA/ICH; strong writing and project management skills.
MaximusNYSE: MMS: Provides government health and human services program administration.
5+ YOE5+ years related experience with a Bachelor's (or 3 years with a Master's, or PhD), technical writing, content management, stakeholder engagement, ability to translate complex information, and health policy knowledge.
Bristol Myers SquibbNew York Stock Exchange: BMY: Develops and distributes innovative medicines for serious diseases.
10+ YOEAdvanced scientific degree or equivalent experience, ~10 years regulatory documentation experience, expert writing skills for regulatory submissions, knowledge of global drug development, document management and publishing processes.
High Wycombe or Leiden or Neuss or Paris or Beerse or Horsham or Spring House or Raritan
HybridFull Time
Johnson & JohnsonNYSE: JNJ: Global healthcare providing pharmaceuticals and medical technologies.
8+ YOEUniversity degree required (Masters/PhD preferred). Minimum 8 years pharmaceutical/scientific experience and 6 years medical writing experience. Strong regulatory knowledge (ICH), submission leadership, English fluency, excellent communication and project leadership skills.
Telix PharmaceuticalsASX: TLX: Develops targeted radiopharmaceuticals for cancer imaging and treatment.
5+ YOE5+ years regulatory medical writing; bachelor in science; CFR/FDA/EMA/ICH knowledge; experience with regulatory documents; strong English; MS Word; leadership and collaboration.
HigherEchelon: Provides leadership development, coaching, and IT consulting services.
3+ YOETechnical writer with mortgage/fintech experience to produce API docs, user guides, and regulatory content; must be U.S. citizen/permanent resident and able to obtain Public Trust clearance; 3+ years technical writing or bachelor's plus 3–5 years.
Microsoft Word, Adobe, Confluence, SharePoint, Markdown, Git, GitHub, GitLab, Microsoft Excel, Microsoft PowerPoint, Microsoft Outlook
United States or Arizona or Connecticut or Delaware or Florida or Georgia or Illinois or Massachusetts or Missouri or New Hampshire or New Jersey or North Carolina or Pennsylvania or Utah or Virginia
$65k-$93k/yrRemoteFull Time
Perceptive: Delivers eClinical software and medical imaging for clinical research.
Experience authoring clinical and regulatory documents, strong scientific writing/editing, familiarity with industry guidelines (ICH-GCP), ability to manage projects and client relationships.
Microsoft Word, Microsoft Excel, Microsoft PowerPoint
London or Germany or Italy or Spain or Ireland or India or United States
RemoteFull Time
EVERSANA: Provides commercialization and logistics services for the pharmaceutical industry.
Proven writing experience, knowledge of global healthcare systems, ability to distill data-heavy documents, use AI tools for productivity, and produce timely news on pricing, policy, HTA and regulatory changes.