Remote Senior Medical Writer - Regulatory Submissions
Synchrogenix Information Strategies, LLC
- Remote job
Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents across product development stages. You will guide teams, synthesize data, and ensure SOP‑compliant submissions, with client‑facing advisory responsibilities and budget oversight. The role emphasizes leadership in study‑level and submission‑level writing, cross‑functional collaboration, and coaching junior staff to meet regulatory standards. #J-18808-Ljbffr Synchrogenix Information Strategies, LLC
$116k - $128k
Veristat, LLC. is looking for a Senior Medical Writer with a clinical focus, responsible for leading... ...role demands a strong background in regulatory writing and clinical documentation, with... ...$116K to $128K and provides a fully remote working option. Benefits include flexible...Remote jobSeniorRegulatoryFlexible hours- A leading data-focused CRO is seeking a Remote Senior Medical Writer to contribute to clinical development documents and mentor team members. Candidates should have strong writing skills, at least three years of experience in the pharmaceutical industry, and an educational...Remote jobSeniorRegulatoryFull time
- ...Syneos Health is seeking a Principal / Senior Medical Writer with proven clinical document writing experience. This remote role supports global regulatory deliverables and cross-functional... ...delivering high-quality manuscripts and submissions on time. #J-18808-Ljbffr...Remote workSeniorRegulatory
- ...Medical Writer MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries... ...with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents...Remote workSeniorRegulatoryWorldwide
$145k - $155k
...Sr. Medical Writer Peripheral Vascular Med Device (U.S. Remote) Position Overview This is a Temp-To-Hire Position Primary... ...Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions, including but not limited to:...Remote workSeniorRegulatoryTemporary workInterim role- ...Senior Medical Writer Join us as we transform immunology and deliver medicines that help autoimmune patients get their lives back.... ...complex clinical, nonclinical, and safety documents for regulatory submissions. This individual will execute the overall strategy for...Remote workSeniorRegulatory
- ...Atlanta, Georgia, Artivion, Inc. is a medical device company focused on developing simple... ...as applicable Writing clinical regulatory documents including annual reports, study... ...Support clinical requirements for regulatory submissions and maintenance. Coordinating...Remote workSeniorRegulatoryInterim roleWorldwide
- ...Senior Strategic Medical Writer AbbVie's mission is to discover and deliver innovative medicines and... ...for leading and writing clinical and regulatory documents for drug and/or device development... ...knowledge and understanding of submission strategies. Coordinates the...Remote workSeniorRegulatoryTemporary work
$145k - $155k
Terumo Group is seeking a Sr. Medical Writer for a remote role in Los Angeles. This position involves collaborating with clinical and regulatory teams to produce a range of medical documents for regulatory submissions, including clinical evaluation reports and study protocols...Remote jobSeniorRegulatory- ...Senior Medical Writer Synterex, Inc. is a global consortium of highly experienced... ...in medical writing, submission publishing, and clinical... ...operations support. Synterex offers remote or on-site services, with a... ...Operations, Biostatistics, Regulatory, and Program Management in...Remote workSeniorRegulatoryLocal area
- MMS Holdings Inc in Boston is seeking a Medical Writer to evaluate medical literature and... ...This role requires at least 3-5 years of regulatory writing experience in the... ...team members and ensuring high-quality submissions to regulatory authorities. #J-18808-Ljbffr...Remote jobSeniorRegulatory
- ...the United States is seeking a Senior Staff Medical Writer for the Endoscopy Division, to be based remotely across the U.S. You will develop scientific and regulatory documents to support global... ...translate complex evidence into submission-ready materials. Requires 6+ years...Remote jobSeniorRegulatory
- ...deep domain expertise in regulatory sciences, clinical... ...compliance, pharmacovigilance, medical information, and R&D... ...experienced medical writers, as necessary. ~... ...of regulatory submission requirements and processes... ...Whilst ProPharma supports remote working, we also...Remote workSeniorRegulatoryContract workWork at office
- ...Senior Medical Writer BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by... ...clinical studies and reporting clinical study results for regulatory submissions and publications. Responsibilities: Drafts and...Remote workSeniorRegulatoryFull timeFor contractorsShift work
- MMS Holdings Inc is seeking a skilled Medical Writer in Chicago. The successful candidate will have a strong background in regulatory writing, including clinical protocols and... ...in supporting clinical research and regulatory submissions. #J-18808-Ljbffr MMS Holdings IncRemote jobSeniorRegulatory
- MMS Holdings Inc in Baltimore, Maryland is seeking a Medical Writer to critically evaluate and write clinical documents for regulatory submissions. This role demands experience in the pharmaceutical industry and exceptional writing skills to produce high-quality documentation...Remote jobSeniorRegulatory
- Syneos Health in Remote/NC seeks a Senior Medical Writer with proven clinical document writing experience. You will lead... ...collaborating with data management, biostatistics, regulatory and medical affairs to produce high-quality submissions. Minimal travel may be required. #J-188...Remote jobSeniorRegulatory
- ...Senior Medical Writer- ICON- Remote USA ICON is a global healthcare intelligence and clinical research... ...formats ~ Strong understanding of regulatory requirements (e.g., ICH-GCP, FDA, EMA) governing the preparation and submission of clinical documents and publications...Remote workSeniorRegulatory
$90k - $140k
...Senior Medical Writer Everest Clinical Research ("Everest") is a full-service contract research... ..., Canada on-site location, or remotely from a home-based office anywhere in... ...accurate and succinct documents supporting regulatory submissions for clinical trial authorizations...Remote workSeniorRegulatoryContract workTemporary workWork from homeWorldwide$126.9k - $215.4k
Your Role As the Senior Principal Medical Writer, you will lead the end-to-end development of complex regulatory submission documents—ensuring high communication quality, scientific rigor... ...management. Vendor management and remote leadership. Strong communication, negotiation...Remote workSeniorRegulatory- Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents and medical communications across product development. You... ...MS or PhD preferred, and strong leadership to guide submission-level documents and #J-18808-Ljbffr VeristatRemote jobSeniorRegulatory
- INC Research is seeking a Senior Medical Writer to support clinical study and regulatory project teams. This position is home based anywhere in the US. The ideal... ...deliverables like clinical protocols, IND submissions, and more, adhering to regulatory standards. Applicants...Remote jobSeniorRegulatoryWork from home
- ...subsidiary of Eli Lilly and Company, is seeking a Senior Medical Writer to author and manage clinical regulatory documents across its development programs,... ...Biostatistics, Pharmacovigilance, and CMC teams to support submissions. #J-18808-Ljbffr Centessa Pharmaceuticals, a...SeniorRegulatory
$110.1k - $183.4k
...Work Flexibility Remote Stryker is hiring a Senior Staff Medical Writer to join our Endoscopy Division, to be based remotely anywhere within the United... ...and other safety and performance sources into submission‑ready regulatory documents. Respond to notified body reviews...Remote workSeniorRegulatoryFor contractorsWork at office- Senior Medical Writer I 12 Months FTC I Fully Remote I Based in EU A leading global clinical research organization is seeking a Senior or Principal Medical... ...(CSRs), investigator brochures (IBs), and regulatory submission documents. Collaborate with cross-functional teams...Remote workSeniorRegulatoryFixed term contract
- Immix Biopharma, Inc. seeks a Senior Medical Writer to prepare, review, and edit regulatory documents for FDA submissions, ensuring accuracy and regulatory compliance across IND, NDA, and BLA programs. You will collaborate with clinical, regulatory, and scientific teams...SeniorRegulatory
- Alnylam Pharmaceuticals in Cambridge, MA, is seeking a Principal Medical Writer (equivalent to Associate Director) to lead medical writing... ...junior staff, and collaborate across functions to ensure timely, high-quality submissions. #J-18808-Ljbffr Alnylam PharmaceuticalsSeniorRegulatoryContract work
- Principal / Senior Medical Writer - with proven strong clinical document writing... ...: Yesterday Location: Remote, NH, Netherlands Job ID: 25... ...clinical development plans; IND submissions; integrated summary reports... .... Adheres to established regulatory standards, including, but...Remote workSeniorRegulatoryContract work
- MMS is a data-focused CRO seeking an experienced Medical Writer to analyze medical literature, develop regulatory documents, and ensure scientific rigor in study... ...in writing projects, experience with regulatory submissions, and strong MS Office skills, with collaboration...SeniorRegulatory
- Senior Medical Writer- ICON- Remote USA ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud... ...study reports (CSRs), investigator brochures (IBs), and regulatory submissions, ensuring accuracy, clarity Collaborating closely...Remote workSeniorRegulatoryFlexible hours
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