Senior Regulatory Medical Writer & Submissions Lead
$119.3k - $159.3kBeiGene, Ltd.
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 industry standards. The ideal candidate holds an advanced degree in life sciences and has significant experience in regulatory writing. A comprehensive benefits package, including competitive salaries ranging from $119,300 to $159,300 annually, is offered. #J-18808-Ljbffr BeiGene, Ltd.
$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...SeniorRegulatoryRemote job- 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
- 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
- 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
- Praxis Precision Medicines, Inc. is searching for a Senior Regulatory Submissions Manager to oversee regulatory submissions to U.S. and international... ...communication with teams. Benefits include comprehensive medical coverage, 401(k) match, stock incentives, and generous PTO...SeniorRegulatoryRemote job
- Digitas Health is seeking a Senior Associate for Regulatory Promotional Operations to manage complex submission deliverables for pharmaceutical clients. The ideal candidate has a Bachelor's degree and 2-4 years of experience in the industry, along with strong skills in...SeniorRegulatoryWork at office
- ...years of relevant experience. The successful candidate will lead complex projects, collaborate with clients, and ensure high-... ...statistical analysis for clinical research, product development, and regulatory submissions. Strong knowledge of drug development processes and ISO...SeniorRegulatory
$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....SeniorRegulatory$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...SeniorRegulatory- 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...SeniorRegulatory
$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...SeniorRegulatoryFlexible hours- 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...SeniorRegulatory
- 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...SeniorRegulatoryFlexible hours
$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...SeniorRegulatoryContract workFlexible hours$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...SeniorRegulatoryFlexible 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...SeniorRegulatoryRemote jobFull time
- 6AM City, LLC is seeking an experienced Medical Writer to join their team. The role involves writing and editing clinical development documents... ...other writers. Candidates should have a strong background in regulatory writing within the pharmaceutical industry, with at least 3-5...Regulatory
- ...Health is seeking a Principal Statistician Oncology with Submission Experience to lead and mentor biostatistics personnel. You'll be responsible... ...trials, and strong proficiency in statistical programming and regulatory submissions. This role includes project leadership and...SeniorRegulatory
$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$80.6k - $145k
Job Responsibilities Leads the clear and accurate completion of medical writing deliverables, ensuring... ...development plans; IND submissions; integrated summary... ...Adheres to established regulatory standards, including,... ...less experienced medical writers on complex projects, as...SeniorRegulatoryContract workFlexible hours- Overview Senior Medical Writer (Remote) at MMS. Join to apply for the Senior Medical Writer (Remote... ...approach to complex trial data and regulatory submission challenges. With a global footprint... ...with clinical study protocols as lead author. Experience leading and managing...SeniorRegulatoryRemote jobFull time
$128k - $176k
Senior Medical Writer Join us as we transform immunology and deliver medicines that help autoimmune... ...contribution to develop content for regulatory submissions that is well‑organized, consistent,... ...writing activities. Supports the lead writer and project teams to ensure...SeniorRegulatoryTemporary work$137.1k - $182.1k
...fit-for-purpose clinical and regulatory documents to facilitate speed... ...information during development, submission, approval, and lifecycle... ...the working scope of global medical writing. This position is also... ...collaboration). Proactively leads direction and strategy setting...SeniorRegulatoryFull timeFor contractorsLocal area$80.6k - $145k
Senior Medical Writer - Regulatory Documents - CSR /Protocol - Late Phase Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate... ...reports, clinical development plans; IND submissions; integrated summary reports; NDA and...SeniorRegulatoryContract workFlexible 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
- Bristol Myers Squibb is looking for a Senior Scientific Writer I to author complex clinical... ...disciplines, ensuring high-quality regulatory submissions. The ideal candidate will manage timelines... ...standards, and innovate in medical writing while adhering to regulatory...SeniorRegulatory
- A pioneering life sciences company in New York is seeking a Senior Regulatory Affairs Manager to shape its regulatory strategy across a diverse... .... This leadership role will manage FDA and global submissions, ensuring the integration between regulatory, R&D, and commercial...SeniorRegulatory
- ...company in New York seeks a Senior Regulatory Affairs Manager. This role involves... ...portfolio of cosmetics and medical devices. Responsibilities... ...regulatory pathways, leading FDA filings, and ensuring integration... ...a proven ability to manage submissions efficiently. The position...SeniorRegulatory
$72k - $90k
A prominent healthcare provider in New York is seeking a Senior Regulatory Consultant to oversee the regulatory compliance of cancer clinical trials. The role involves managing trial submissions, ensuring compliance from approval to closure, and mentoring junior staff....SeniorRegulatory- A leading cancer treatment center in New York is seeking a Senior Regulatory Compliance Coordinator to oversee clinical trials and ensure compliance with regulatory... ...closely with investigators, manage regulatory submissions, and mentor junior staff. A Bachelor’s degree...SeniorRegulatory
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