Senior Nonclinical Writer - Remote, Regulatory Submissions
MMS Holdings Inc
- Remote job
MMS Holdings Inc. is seeking a skilled regulatory writer to join our team, focusing on nonclinical documents for regulatory submissions. You will develop, write, and manage Module 2.4/2.6 eCTD content, IBs, study reports, and briefing documents. This full-time, remote role requires strong knowledge of GLP/ICH guidelines, excellent writing and project management skills, and the ability to lead cross-functional teams to deliver compliant submissions for INDs, CTAs, NDAs, BLAs, and MAAs. #J-18808-Ljbffr MMS Holdings Inc
- MMS Holdings Inc. is seeking a Regulatory Nonclinical Writer for a full-time remote role. The candidate will develop and manage highly technical nonclinical documents to support regulatory submissions, including Module 2.4/2.6, IBs, and study reports, collaborating with...Remote jobSeniorRegulatoryFull time
- ...Join MMS: Nonclinical Document Development Specialist Are you looking to join a company... ...approach to complex trial data and regulatory submission challenges. With a global footprint across... ...documents. This is a full-time, remote position. Roles and Responsibilities...Remote workSeniorRegulatoryFull time
- 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
- 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...Remote jobSeniorRegulatory
- An established industry player is seeking a Nonclinical Regulatory Document and Scientific Writer to join their dynamic team. This role requires a strong background in DMPK and regulatory drug development, with responsibilities including authoring and reviewing critical...SeniorRegulatory
- ...leading CRO in Charleston, SC is seeking a Nonclinical Writer to develop and manage nonclinical... ...ideal candidate will have 2+ years of regulatory writing experience along with strong analytical... ...communication skills. This full-time, remote role offers the opportunity to work in...Remote jobRegulatoryFull time
- ...clinical research organization is seeking a technical writer to develop and manage nonclinical documents. This full-time remote position requires a BS in pharmacology or related fields, with a minimum of 2 years in regulatory writing. Candidates should possess strong...Remote jobRegulatoryFull time
- ...clinical research organization is seeking a Nonclinical Writer to develop and manage highly technical nonclinical documents. This remote, full-time role involves close... ...teams and requires strong writing skills, regulatory knowledge, and the ability to navigate complex...Remote jobRegulatoryFull time
- Merck & Co., Inc. in California seeks an experienced Medical Writer to join our Nonclinical Pharmacology Documentation group, managing multiple preclinical programs and regulatory modules. You will collaborate with research and regulatory teams to produce high-quality...SeniorRegulatory
- 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
$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$55 - $75 per hour
...This is a Contract role- Remote can live anywhere in the... ...US- $55 to $75hour The Senior Medical Writer applies advanced documentation... ...study results for regulatory submissions and publications. Responsibilities... ...concepts integral to nonclinical development, CMC, PK, PD,...Remote workSeniorRegulatoryFull timeContract workFor contractorsWorldwideShift work- Merck seeks an experienced Medical Writer to join the Nonclinical Pharmacology Documentation group. You will generate preclinical reports and submission modules, partner with research and regulatory functions, and manage multiple programs with competing timelines to meet...SeniorRegulatory
$132k - $151k
...The Principal Medical Writer independently plans and prepares a range of regulatory documents and medical... ...inclusive culture — 70% remote workforce, 66% women‑... ...equivalent experience with nonclinical sections of the CTD... ...in the development of submission‑level documents Skills...Remote workRegulatoryLocal areaWorldwideFlexible hours- ...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
- ...Stryker is hiring a Senior Staff Medical Writer for its Endoscopy Division. This remote, nationwide role focuses on developing regulatory and scientific documents to support global registrations... ...into CERs, PMCF, and other submissions, coordinating with Regulatory, Clinical...Remote workSeniorRegulatory
$145k - $155k
...Sr. Medical Writer Peripheral Vascular Med Device (U.S. Remote) Position Overview This is a Temp-To-Hire Position... ...Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions, including but not limited to: Clinical...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- ...with a proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents,... ...LinkedIn. Responsibilities Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical...Remote workSeniorRegulatoryWorldwide
- ...Senior Medical WriterSynterex, Inc. is a global consortium... ...in medical writing, submission publishing, and... ...support. Synterex offers remote or on-site services,... ...team. The senior medical writer will partner cross-... ...Operations, Biostatistics, Regulatory, and Program...Remote workSeniorRegulatoryLocal area
- ...seeking an experienced Medical Writer to join a sponsor-aligned... ...including 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
- ...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 pharmaceutical... ...team members and ensuring high-quality submissions to regulatory authorities. #J-18808-Ljbffr...Remote jobSeniorRegulatory
- ...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... ...vital in supporting clinical research and regulatory submissions. #J-18808-Ljbffr MMS Holdings IncRemote 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
- ...Senior Strategic Medical WriterAbbVie's mission is to discover and... ....The Senior Strategic Medical Writer is responsible for leading and writing clinical and regulatory documents for drug and/or device... ...and understanding of submission strategies.Coordinates the review...Remote workSeniorRegulatoryTemporary work
- 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
- 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
- ...Customs Entry Writer FTZ Specialist We are the leading provider... ...and timely preparation, submission, and management of U.S. Customs... ...country of origin, valuation, and regulatory admissibility Maintain... .../2026, 03:34 PM Locations Remote Location, Charlotte, NC, 2820...Remote workSeniorRegulatoryFull timeWork at officeLocal areaWorldwide
- ...regulations and standards as applicable Writing clinical regulatory documents including annual reports, study summaries, and other... ...rationales. Support clinical requirements for regulatory submissions and maintenance. Coordinating company deliverables such as...Remote workSeniorRegulatoryInterim roleWorldwide
- Veristat is seeking a Principal Medical Writer to independently plan and prepare regulatory documents and medical communications across product development... ...with MS or PhD preferred, and strong leadership to guide submission-level documents and #J-18808-Ljbffr VeristatRemote jobSeniorRegulatory
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