Sign up to access all features of our service.
  • Job search
  • Favorites
  • Create a CV
    New
  • Salaries
  • Subscriptions

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

Vacancy posted 3 days ago
Similar jobs that could be interesting for youBased on the Lead Medical Writer - Regulatory Submissions & Strategy in New York, NY vacancy
  • 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 Apr
    Regulatory
    Contract work

    Apr

    New York, NY
    11 hours ago
  • $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

    BeiGene, Ltd.

    New York, NY
    11 hours ago
  • 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

    Bristol Myers Squibb

    New York, NY
    3 days ago
  • 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... 
    Regulatory
    Remote job
    Flexible hours

    ICON Strategic Solutions

    New York, NY
    2 days ago
  • $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... 
    Regulatory
    Remote job

    Praxis Precision Medicines, Inc.

    New York, NY
    2 days ago
  •  ...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... 
    Regulatory
    Remote work

    Neurogene, Inc.

    New York, NY
    3 days ago
  •  ...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

    Taylor Strategy Partners

    New York, NY
    2 days ago
  • $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... 
    Regulatory
    Remote work

    Recursion

    New York, NY
    1 day ago
  • 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

    Gan & Lee Pharmaceuticals

    New York, NY
    2 days ago
  • 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

    argenx SE

    New York, NY
    1 day ago
  • $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... 
    Regulatory
    Remote job
    Hourly pay
    10 hours per week
    Flexible hours

    Crossing Hurdles

    New York, NY
    2 days ago
  • 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

    TechData Service

    New York, NY
    2 days ago
  • $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... 
    Regulatory
    Contract work
    For contractors
    Local area

    Fluidstack

    New York, NY
    9 days ago
  • $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,... 
    Regulatory
    Worldwide
    Flexible hours

    Sanofi

    New York, NY
    2 days ago
  • $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

    Vera Therapeutics, Inc.

    New York, NY
    2 days ago
  • 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... 
    Regulatory
    Remote job
    Full time

    MMS

    New York, NY
    2 days ago
  • $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... 
    Regulatory
    Flexible hours

    Syneos Health/ inVentiv Health Commercial LLC

    Brooklyn, NY
    2 days ago
  • $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

    Syneos Health/ inVentiv Health Commercial LLC

    New York, NY
    2 days ago
  • $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

    Syneos Health/ inVentiv Health Commercial LLC

    Brooklyn, NY
    21 hours ago
  • $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... 
    Regulatory
    Flexible hours

    Syneos Health/ inVentiv Health Commercial LLC

    New York, NY
    3 days ago
  • $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... 
    Regulatory
    Flexible hours

    Syneos Health/ inVentiv Health Commercial LLC

    New York, NY
    1 day ago
  • 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

    New York, NY
    2 days ago
  • 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... 
    Regulatory
    Flexible hours

    Syneos Health/ inVentiv Health Commercial LLC

    New York, NY
    4 days ago
  • 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... 
    Regulatory
    Remote job
    Full time

    Veristat LLC

    New York, NY
    3 days ago
  • 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

    BeiGene, Ltd.

    New York, NY
    4 days ago
  • $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... 
    Regulatory
    Contract work
    Flexible hours

    Syneos Health/ inVentiv Health Commercial LLC

    Brooklyn, NY
    2 days ago
  • $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... 
    Regulatory
    Temporary work

    argenx SE

    New York, NY
    1 day ago
  • $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... 
    Regulatory
    Remote work
    Flexible hours

    GLE Creative Talent, Inc.

    New York, NY
    3 days ago
  • $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... 
    Regulatory
    Work experience placement
    Local area
    Remote work
    Flexible hours

    Itlearn360

    New York, NY
    3 days ago
  • $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... 
    Regulatory
    Full time
    For contractors

    BeiGene, Ltd.

    New York, NY
    11 hours ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Lead Medical Writer - Regulatory Submissions & Strategy. Be the first to apply!