Lead Medical Writer - Regulatory Submissions & Strategy
6AM City, LLC
6AM City, LLC is seeking an experienced Medical Writer to join their team. The role involves writing and editing clinical development documents, managing timelines, and mentoring other writers. Candidates should have a strong background in regulatory writing within the pharmaceutical industry, with at least 3-5 years of experience. The ideal applicant holds a degree in a scientific or medical discipline and possesses exceptional writing and organizational skills. #J-18808-Ljbffr 6AM City, LLC
- Apr is seeking a Contract Senior Manager, Regulatory Affairs, to oversee the submission of regulatory documents to National Health Authorities. This role... ..., and collaborate with various internal teams while developing effective regulatory strategies. #J-18808-Ljbffr AprRegulatoryContract work
$119.3k - $159.3k
BeiGene, Ltd. is seeking a Regulatory Writer to join its dynamic team in the United States. This role involves developing high-quality clinical and regulatory documents to ensure timely submissions of products. You will also mentor junior writers, ensuring compliance with...Regulatory- Lead of Medical Writer Location: Beijing-CN Responsibilities Lead the Medical Writing team within Bristol Myers Squibb (BMS) China Regulatory Affairs. Ensure delivery of high-quality regulatory and... ...Support streamlined, compliant submissions to NMPA and global health...Regulatory
- A leading healthcare intelligence firm is seeking a Principal Medical Writer to lead the development of regulatory and clinical documents. The ideal candidate will have an advanced degree... ..., particularly in regulatory submissions. This role offers a competitive salary...RegulatoryRemote jobFlexible hours
$130k - $150k
A clinical-stage biopharmaceutical firm is seeking a Medical Writer to support clinical development programs. The candidate will be responsible for producing high-quality regulatory documents and collaborating with cross-functional teams to ensure compliance. Requirements...RegulatoryRemote job- ...Neurogene Inc. is seeking a VP of Regulatory Affairs to lead the regulatory strategy and manage submissions like INDs and NDAs. This highly experienced person will work with the Senior VP of Regulatory Affairs to ensure compliance throughout the product's life cycle and...RegulatoryRemote work
- ...rare disease company is seeking a Director/Senior Director of Regulatory Affairs. In this strategic role, you will manage global regulatory strategies for submissions in the US, EU, UK, and Japan. You will lead major submissions, engage with regulatory agencies like the...Regulatory
$176.4k - $207.5k
Recursion is seeking an Associate Director of Regulatory Affairs to lead global regulatory strategies and oversee processes. This role requires at least 10 years of experience in the pharmaceutical industry, with 8 years in Global Regulatory Affairs. The ideal candidate...RegulatoryRemote work- Gan & Lee Pharmaceuticals is seeking a Regulatory Affairs professional to support the implementation of regulatory strategies. Responsibilities include ensuring compliance for product submissions and regulatory interactions. The ideal candidate will have a Bachelor of...Regulatory
- 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...Regulatory
$30 - $100 per hour
A regulatory consultancy is seeking a Regulatory Medical Writer to develop structured prompts and review critical documentation for FDA submissions. The ideal candidate should have proven experience in preparing regulatory documents, deep knowledge of FDA and ICH guidelines...RegulatoryRemote jobHourly pay10 hours per weekFlexible hours- TechData Service is seeking a Medical Writer with an advanced degree and 3-5 years of experience in medical writing... ...will have a strong background in writing regulatory documents for clinical trials and submissions, and must be able to simplify complex scientific...Regulatory
$225k - $275k
...Role Fluidstack is seeking a Lead, Network Connectivity & Strategy to own our external connectivity strategy... ...familiarity is a plus. Regulatory & Right-of-Way Knowledge: Familiarity... .... If there is an error with your submission and you did not receive a confirmation...RegulatoryContract workFor contractorsLocal area$122.25k - $176.58k
## Global Submission LeadBewerbenlocations: Morristown,... ...:** Global Submission Lead* **Location:** Morristown... ..., and tracking of regulatory Priority portfolio and... ...implementation of e-Submission strategies between two companies.... ...is out there. Better medications, better outcomes,...RegulatoryWorldwideFlexible hours$259k - $394k
...biotechnology company is seeking a Vice President of Regulatory Affairs to develop and execute regulatory strategies for global pipeline programs. The ideal... ...and will be responsible for managing regulatory submissions, leading health authority interactions, and mentoring a...Regulatory- 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...RegulatoryRemote jobFull time
$80.6k - $145k
...Health/ inVentiv Health Commercial LLC is seeking a Medical Writer in Oklahoma. This role involves leading medical writing activities, ensuring the clarity... ...accuracy of various clinical documents, and adhering to regulatory standards. Candidates should have 3-5 years of...RegulatoryFlexible hours$80.6k - $145k
A leading biopharmaceutical solutions organization is seeking a Senior Medical Writer specialized in regulatory documents. In this role, you'll lead the preparation of clinical documents and manage writing activities while ensuring compliance with regulatory guidelines....Regulatory$80.6k - $145k
A leading biopharmaceutical solutions organization seeks a Senior Medical Writer specializing in regulatory documents. This role involves leading the medical writing process, ensuring compliance with regulatory standards, and mentoring junior writers. Candidates should...Regulatory$80.6k - $145k
...Health/ inVentiv Health Commercial LLC is looking for a Medical Writer in Delaware. The role involves leading medical writing deliverables, ensuring accuracy and... ...include writing clinical documents, adhering to regulatory standards, and mentoring junior writers. The...RegulatoryFlexible hours$80.6k - $145k
A leading biopharmaceutical solutions organization in New Jersey is seeking a Senior Medical Writer to manage and complete regulatory documents. Responsibilities include writing clinical study protocols, ensuring adherence to regulatory standards, and mentoring junior writers...RegulatoryFlexible hours- A leading biopharmaceutical solutions organization in Georgia is seeking a Senior Medical Writer specializing in regulatory documents. The selected candidate will lead medical writing deliverables for clinical studies, ensuring compliance with regulatory standards and high...Regulatory
- Syneos Health/ inVentiv Health Commercial LLC is seeking an experienced medical writer in Georgia. The role involves leading medical writing projects, ensuring compliance with regulatory standards, and mentoring junior writers. You will create clinical documents and engage...RegulatoryFlexible hours
- Veristat LLC is seeking a full-time Principal Medical Writer to independently plan and prepare regulatory documents and medical communications. This remote role involves supporting all phases of product development while collaborating with cross-functional teams. The ideal...RegulatoryRemote jobFull time
- BeiGene, Ltd. is seeking a Medical Writer to develop high-quality clinical and regulatory documentation to support product lifecycle management. The role involves managing writing tasks, ensuring compliance with regulatory guidelines, and mentoring other writers. Candidates...Regulatory
$80.6k - $145k
...Health/ inVentiv Health Commercial LLC in Kentucky is seeking a Medical Writer to lead clear and accurate medical writing projects. The successful... ...include completing clinical documents, adhering to regulatory standards, and mentoring junior writers. The position offers...RegulatoryContract workFlexible hours$128k - $176k
Senior Medical Writer Join us as we transform immunology and deliver... ...contribution to develop content for regulatory submissions that is well‑organized,... ...activities. Supports the lead writer and project teams to... ..., goals, measures, and strategies. Capable of working on multiple...RegulatoryTemporary work$100k - $160k
...the job Market Access Medical Writer Senior Medical Writer... ...Shapes Market Access Strategy Remote Position (EST... ...competitor landscapes. Lead content creation... ..., and compliant with regulatory guidelines. Guide medical... .../regulatory approval submissions , incorporating...RegulatoryRemote workFlexible hours$75k - $85k
Medical Writer (Med Affairs) job at Real Chemistry. New York, NY. Working... ...execution of scientific strategies and tactics. This is a... ...accuracy, and support Veeva submissions of all medical communication... ...deliverables for client medical/legal/regulatory reviews by highlighting all...RegulatoryWork experience placementLocal areaRemote workFlexible hours$119.3k - $159.3k
...As a key member of the regulatory writing team, you will develop... ...facilitating the timely submission and life‑cycle... ...will also mentor junior medical writers (full‑time employees and... ...complex or urgent projects. Lead document development strategy, collaborate with study...RegulatoryFull timeFor contractors
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