Senior Medical Writer - Remote Regulatory Submissions
Simulstat
- 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
- ...Senior Medical Writer - Clinical Development Immix Biopharma, Inc. United States / Remote / LA, CA Our 3 Core Values Intelligence Integrity... ...preparing, reviewing, and editing regulatory documents required for submission to the U.S. Food and Drug...Remote workSeniorRegulatoryOdd jobFull time
- ...community. We are currently looking for a REMOTE Associate Director Medical Writer to work for a leading San Diego... ...Development, Biostatistics, and Regulatory teams to translate complex data... ..., comment resolution, and on-time submission readiness • Ensure all...Remote workSeniorRegulatoryWork at office
- ...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
- ...Job Title Provides high-quality regulatory medical and scientific writing in support of Phase... ...Reviews documents prepared by junior writers and peers. May provide training and mentorship... ...client timelines and regulatory submission deadlines. Demonstrates accountability...Remote workSeniorRegulatoryContract work
- Syneos Health, Inc. seeks a Senior/Principal Medical Writer with a regulatory focus to lead and manage medical writing... ...timelines within budget. Remote work is available in the US, UK,... ...modules, CSRs, IBs, and regulatory submissions, with strong client interaction and...Remote jobSeniorRegulatory
$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$55 - $75 per hour
...patients with significant unmet medical need. We enlist the best... ...This is a Contract role- Remote can live anywhere in the US- $55 to $75hour The Senior Medical Writer applies advanced... ...clinical study results for regulatory submissions and publications. Responsibilities...Remote workSeniorRegulatoryFull timeContract workFor contractorsWorldwideShift work- Syneos Health, Inc. is seeking a Senior Medical Writer for Early Phase (Single Sponsor Support). This remote role spans multiple regulatory documents and collaborations across departments to deliver compliant submissions. The candidate should have strong EMA/FDA/ICH knowledge...Remote jobSeniorRegulatory
$84.37k - $120.53k
## Senior Medical WriterApply: Remote (US): Full time: Posted 2 Days Ago: JR104959**About Perceptive*... ...About the role**A Senior Medical Writer will create, research, edit and coordinate... ...clinical documents for submission to regulatory authorities.* Prepare, develop, and...Remote workSeniorRegulatoryFull timeContract workWork at officeFlexible hours$101.7k - $136.7k
...Senior Medical Writer BeOne continues to grow at a rapid pace with challenging and exciting opportunities... ..., editing, and formatting clinical regulatory documents that conform to domestic and/or international regulatory submission and internal document standards, while...Remote workSeniorRegulatoryHourly payContract workLocal areaShift work- ...focused clinical research organization, as a Medical Writer. This full-time, UK-remote role focuses on producing regulatory medical writing deliverables with rigorous... ...while collaborating across functions to ensure timely, high-quality submissions. #J-18808-Ljbffr MMSRemote jobSeniorRegulatoryFull time
- ...Thermo Fisher Scientific seeks a Senior Regulatory Medical Writer for remote work in the US. The role involves authoring clinical and preclinical regulatory... ..., and mentoring junior writers to support regulatory submissions and communications. Responsibilities Author...Remote workSeniorRegulatoryWork at office
- 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... ...vital in supporting clinical research and regulatory submissions. #J-18808-Ljbffr MMS HoldingsRemote jobSeniorRegulatory
- MMS, a data-focused CRO, is seeking an experienced Medical Writer to critically assess literature, craft clinical development documents, and manage writing projects for regulatory submissions. The role requires leadership of project teams, strong communication with clients...Remote 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
- Immix Biopharma, Inc. is seeking a Senior Medical Writer to prepare, review, and edit regulatory documents for FDA submissions. You will work with clinical, regulatory, and scientific teams to ensure accuracy, compliance, and timely delivery across IND, NDA, and BLA programs...SeniorRegulatory
- ...clinical research organization, seeks a Medical Writer to craft regulatory and clinical development documents.... ...teams to ensure high-quality submissions and maintain strict timelines. Ideal... ...authoring projects under tight deadlines. Remote work is available for Brazil-based...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
$90k - $100k
...Position Summary: The Senior Medical Writer serves as an integral part... ..., or San Francisco-or remotely within the US, depending on... ...accuracy, and support Veeva submissions of all medical communication... ...deliverables for client medical/legal/regulatory reviews by highlighting all...Remote workSeniorRegulatoryWork experience placementCasual workWork at officeLocal areaNight shiftWeekend work2 days per week$145k - $155k
Sr. Medical Writer Peripheral Vascular Med Device (U.S. Remote) Position Overview This is a Temp-To-Hire Position Primary contact... ...Collaborating with the clinical & regulatory teams to write clinical documents for regulatory submissions, including but not limited to:...Remote workSeniorRegulatoryTemporary workInterim role$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 with a clinical focus to... ...authoring and mentoring across regulatory documents for diverse client engagements. This fully remote role supports US, Canada,... ...tight timelines. You will drive submission-level sections, oversee...Remote jobRegulatory
- ProPharma Group is seeking a senior medical writer to lead authoring and coordination of regulatory submissions and clinical study documents. You will collaborate with medical writing leadership, operations, and clients to deliver high-quality materials on time. The role...SeniorRegulatory
- ...professionals specializing in medical writing, submission publishing, and clinical... ...operations support.Synterexoffers remote or on-site services, with a... ...team.Theseniormedical writer will partner cross-... ...Clinical Operations,Biostatistics,Regulatory, and Program Management...Remote workSeniorRegulatoryLocal area
- ...professionals specializing in medical writing, submission publishing, and clinical... ...support. Synterex offers remote or on‑site services, with... ...writing team. The senior medical writer will partner cross‑functionally... ..., Biostatistics, Regulatory, and Program Management to...Remote workSeniorRegulatoryLocal area
- ...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
- 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
$80.6k - $175.7k
Senior Medical Writer (FSP) - Clinical document writing experience (Protocols... ...) Updated: Today Location: Remote, MO, United States Job ID:... ...clinical development plans; IND submissions; integrated summary reports... .... Adheres to established regulatory standards, including, but...Remote workSeniorRegulatoryContract workFlexible hours- Perceptive is seeking a Senior Medical Writer to create, edit, and coordinate clinical documents for independent review and regulatory submissions. The role involves serving as a key client contact... ...teams in a fast-paced, fully remote US environment. #J-18808-Ljbffr PerceptiveRemote jobSeniorRegulatory
$70 - $80 per hour
...firm specializing in IT is looking for a Senior Medical Writer to manage the medical writing function... ...drafting clinical study protocols, regulatory documents, and managing review timelines... ...This full-time position is primarily remote, with a competitive pay range of $70 -...Remote workSeniorRegulatoryHourly payFull timeContract work
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