Senior Medical Writer - Remote Regulatory Submissions
SimulStat Inc.
- Remote job
SimulStat Inc. seeks a Sr. Medical Writer to support the development of global regulatory documentation strategy and the execution of tactics. You will conceptualize and develop medical communications for reviewer-friendly clinical documents to support regulatory agency review, coordinating progress against global regulatory plans. The role requires a strong background in medical writing, regulatory submissions, and project management, with 6–8 years of industry experience and advanced degrees #J-18808-Ljbffr SimulStat Inc.
- 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
$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$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- ...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... ...minimal supervision, the Medical Writer will critically evaluate, analyze, and...Remote workSeniorRegulatoryWorldwide
- ...Create responses for audit/submission queries.Maintain a... ...plans and reports for regulatory authorities.Review/... ...knowledge of EU MDR and Medical Writing from CER, CEP,... ...or any site in MN, or remote. No requirement to be... ...Influence: Communicates with senior internal and external...Remote workSeniorRegulatoryFull timePart time
- ...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
- Parexel is seeking an experienced Medical Writer to join a sponsor-aligned... ...CTRs, CTPs, IBs, and submission documents, collaborating closely... ...teams to ensure high-quality regulatory deliverables. You will... ...and sponsor compliance in a remote US setting. #J-18808-Ljbffr...Remote jobSeniorRegulatory
- ...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
$126.9k - $215.4k
...Senior Principal Medical WriterAs the Senior Principal Medical Writer, you will lead the end-to-end development of complex regulatory submission documents – ensuring high communication quality, scientific... ...management and remote leadershipStrong communication...Remote workSeniorRegulatoryLocal areaImmediate start- 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
- argenx SE is seeking a Senior Medical Writer to author and manage contributions for regulatory submissions, ensuring compliance with medical writing standards. The successful candidate will have a strong background in pharma or biotech, with at least 3 years of clinical...SeniorRegulatory
- 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
- Stryker is seeking a Senior Staff Medical Writer for its Endoscopy division. This role can be based remotely anywhere in the United States and... ...creating and maintaining regulatory documentation, CERs, PMCF,... ..., ensuring compliant, submission-ready documentation across...Remote jobSeniorRegulatory
$96.5k
...issues today and address the medical challenges of tomorrow. We... ...Job Description The Senior Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents for drug and/or... ...knowledge and understanding of submission strategies. Coordinates...Remote workSeniorRegulatoryTemporary workLocal area- ...Medical Writing Specialist For the past 25 years... ...deep domain expertise in regulatory sciences, clinical... ..., NDA, BLA, MAA, eCTD submission level documents). Supervises... ...experienced medical writers, as necessary.... ...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
- 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
- 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
$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$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
- AbbVie is seeking a Principal Medical Writer to lead and write clinical and regulatory documents for drug and device development. You will work with cross-functional... ...to develop content, ensure quality, and support submission objectives. The role requires strong writing...SeniorRegulatory
- 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
- Merck & Co., Inc. seeks an experienced Medical Writer to join the Nonclinical Pharmacology Documentation group. You will generate preclinical reports and regulatory submission modules, partnering with research and regulatory teams to ensure high-quality scientific and...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
- ...FSP has an exciting opportunity for a Medical Writer ! Key Accountabilities :... ...and finalize clinical documents for submission to regulatory authorities, including but not limited... ...Sciences or equivalent. #LI-KW1 #LI-REMOTE EEO Disclaimer...Remote workSeniorRegulatoryInterim roleFlexible hours
- ...Job Description Job Title: Medical Writer IV Location: Santa Clara, CA (remote) Contract Duration: 1 year... ...Devices. The Medical Writer on our Regulatory Clinical Evaluation team provides... ...preparation for product applications and submissions. Collaborates with team...Remote workSeniorRegulatoryContract workWork experience placement
- ## Job Details: Senior Manager, Medical/Regulatory WriterFull details of the job.| | ||... ...Manager, Medical/Regulatory Writer || | VN831 || | Full Time... ..., MD, Radnor, PA, Remote, US || | Regulatory Affairs... ...assigned programs to support submissions from first-in-human studies...Remote workSeniorRegulatoryFull timeContract work
- ...MMS Holdings Inc is seeking an experienced Medical Writer located in Bridgeport, Connecticut, to support the pharmaceutical and biotech... ...clinical development documents and requires a strong background in regulatory writing alongside exceptional writing and organizational...Remote workSeniorRegulatory
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