Senior Regulatory Medical Writer & Submissions Lead
$119.3k - $159.3kBeiGene
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
- ...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 biopharmaceutical company is looking for a Senior Medical Writer to develop clinical documents for regulatory submissions. The candidate will manage medical writing projects, lead timelines, and collaborate with cross-functional teams. Key qualifications include...SeniorRegulatoryRemote work
- ...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 workFlexible hours
$93.6k - $123.6k
...BeiGene, Ltd. is looking for a Senior Associate in Regulatory Promotional Operations in the United States... ...while supporting regulatory submissions. Ideal candidates should have a BA/BS... ...annually, along with benefits including medical, dental, vision, 401(k), and paid time...SeniorRegulatory- ...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 work
$101.8k - $152.6k
...Precision Medicine Group is seeking a Medical Writer to lead the development of high-quality clinical study documents. Responsibilities include... ...QC review of critical clinical documents compliant with regulatory guidelines (ICH, FDA). The candidate must have a BS degree...SeniorRegulatory- 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- 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
...Health/ inVentiv Health Commercial LLC is looking for an experienced Medical Writer in Idaho. The ideal candidate will lead the completion of a variety of medical documents and ensure compliance with regulatory standards. A strong understanding of FDA and ICH guidelines is...SeniorRegulatoryContract work- 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$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 work- ...Overview Senior Medical Writer (Remote) at MMS. Join to apply for the Senior Medical Writer (... ...approach to complex trial data and regulatory submission challenges. With a global footprint... ...experience with clinical study protocols as lead author. Experience leading and...SeniorRegulatoryFull timeRemote work
$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$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$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$115k - $185k
...A medical device company is seeking a Senior Regulatory Affairs Specialist to lead regulatory submissions and strategy for new product development. This role offers flexibility in levels and can be remote, aligned with US East Coast hours. Candidates should have a Bachelor...SeniorRegulatoryRemote work- ...A leading biotechnology company is seeking a Regulatory Writing Senior Manager to lead writing activities for product submissions. This role involves authoring and overseeing... ...and mentoring junior writers. The ideal candidate... ...strong experience in medical writing within the...SeniorRegulatoryRemote workFlexible hours
$173.7k - $202.65k
...Cytokinetics, Inc. is seeking a Senior Manager, Regulatory Writing to oversee the development of regulatory... ...documents essential for product submissions. This role involves writing and... ...should be adept in project management and leading documentation efforts across teams. A...SeniorRegulatoryRemote work- 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
- ...Regulatory Reporting Team Senior Lead Analyst New York City, NY or Charlotte, NC or Tampa, FL (Hybrid) 8+ Months Web Cam Interview $85/hr on W2... ...for supporting the accurate and timely preparation and submission of regulatory reports to various constituencies based on...SeniorRegulatory
- A leading regulatory consultancy located in New Jersey is seeking an experienced Regulatory Affairs specialist... ...involves supporting US and EU regulatory submissions while ensuring adherence to regulations concerning medical devices. The ideal candidate should have over...SeniorRegulatoryWork at office
- ...A global clinical research organization is seeking a highly organized Senior Regulatory Affairs Associate to coordinate regulatory submissions across regions. The successful candidate will manage submission activities, ensuring timely and compliant filings that support...SeniorRegulatory
$110k - $135k
...DNA Technologies is looking for a Regulatory Affairs Specialist to manage regulatory submissions and ensure compliance within... ...sciences and diagnostics. You will lead the creation of regulatory... ...includes benefits like 401(k) and medical insurance. #J-18808-Ljbffr Integrated...SeniorRegulatoryRemote job- ...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
- ...A leading biopharma company is seeking a Senior level Medical Writer to support clinical and regulatory writing projects. The role requires at least 8 years of medical writing experience in the biopharma industry and involves authoring key clinical documents, collaborating...SeniorRegulatoryContract workRemote work
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Senior Regulatory Medical Writer & Submissions Lead. Be the first to apply!
- medical editor New York, NY
- medical writer New York, NY
- freelance medical writer New York, NY
- medical writer remote New York, NY
- senior medical writer New York, NY
- freelance medical copywriter New York, NY
- senior game producer New York, NY
- senior manager process engineering New York, NY
- senior manufacturing engineer New York, NY
- senior director fp&a New York, NY

