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

Senior Medical Writer Regulatory Dossier & Strategy Leader

GSK LLP

GSK is hiring a Principal Medical Writer in Durham, North Carolina, responsible for leading the authoring of clinical and regulatory documents. The ideal candidate has over 5 years of experience in medical writing and a Bachelor’s degree in life sciences or a related field. Responsibilities include managing writing projects, translating clinical data, and ensuring compliance with regulatory standards. GSK offers a dynamic working environment with a focus on employee wellbeing and inclusivity. #J-18808-Ljbffr GSK LLP

Vacancy posted 2 days ago
Similar jobs that could be interesting for youBased on the Senior Medical Writer Regulatory Dossier & Strategy Leader in Durham, NC vacancy
  • GlaxoSmithKline is seeking a Principal Medical Writer in Durham, NC to lead medical writing for complex clinical and regulatory projects. The ideal candidate will have 5+ years of experience in the pharmaceutical industry and a Bachelor's degree in life sciences. This... 
    Regulatory

    GlaxoSmithKline

    Durham, NC
    22 hours ago
  • GlaxoSmithKline in Durham, North Carolina is seeking a Principal Medical Writer to lead regulatory document preparation for complex clinical projects. This role demands excellent communication skills and a strong background in medical writing, with a focus on HIV-related... 
    Regulatory
    Remote job

    GlaxoSmithKline

    Durham, NC
    2 days ago
  • GlaxoSmithKline is seeking a Principal Medical Writer for their Durham office. The ideal candidate will lead complex medical writing projects and collaborate with cross-functional teams on regulatory submissions. Key requirements include over 5 years in medical writing... 
    Regulatory
    Remote job
    Work at office

    GlaxoSmithKline

    Durham, NC
    2 days ago
  • Zimmer Biomet is seeking a Site Quality Leader and Management Representative at our...  ...to direct the quality function for medical device design and manufacturing. You...  ...develop and implement a site-wide quality strategy aligned with regulatory requirements (QMSR, GMP, ISO) and... 
    Senior
    Regulatory

    Zimmer Biomet

    Durham, NC
    2 days ago
  • $84.4k - $211.1k

     ...Job Overview: Acts as Lead Medical Writer on most types of writing projects. Prepares assigned...  ...as to the agreed timelines. Performs Senior Review of straightforward medical...  ...current medical and/or technical writing/regulatory knowledge, including Good Clinical Practice... 
    Senior
    Regulatory
    Full time
    Part time
    Local area
    Immediate start
    Worldwide

    IQVIA

    Durham, NC
    4 days ago
  • Labcorp is seeking a Senior Manager for their Learning Management System (LMS), responsible for overseeing technical strategy, governance, and operations. This position requires expertise...  .... Benefits include comprehensive medical, dental, and vision coverage, as well as... 
    Senior
    Flexible hours

    Labcorp

    Durham, NC
    2 days ago
  •  ...selection, trial protocols, analysis plans, study reports and regulatory submissions as appropriate. Work in close collaboration with biologists...  ...and simulation contributions to R&D pipeline. Present strategy and defend outcome of model-based approaches to internal... 
    Senior
    Regulatory
    Local area

    GlaxoSmithKline

    Durham, NC
    2 days ago
  • $120k - $159k

    Overview Join to apply for the Senior/Principal Medical Writer - USA role at Trilogy Writing & Consulting, An Indegene Company . Trilogy Writing...  ...Writers (USA) to support our growing company in producing regulatory documentation for the international pharmaceutical... 
    Senior
    Regulatory
    Live in
    Work at office
    Remote work
    Work visa

    Trilogy Writing & Consulting, An Indegene Company

    Durham, NC
    2 days ago
  •  ...high-level design solutions, provide strategic guidance to project teams, and ensure alignment of design components with business strategies. Candidates should have extensive project management experience and strong communication skills. This role may require some... 
    Senior

    pathwayRP

    Durham, NC
    2 days ago
  • $94.5k - $138.6k

    A global healthcare leader is seeking a Senior Manager, Quality Assurance in Durham, NC. This role involves leading a QA organization to ensure compliance with regulatory standards and manage quality processes in manufacturing. The ideal candidate has significant experience... 
    Senior
    Regulatory
    Day shift

    BioSpace, Inc.

    Durham, NC
    2 days ago
  • $190k - $260k

    Shattuck Labs, Inc. is seeking a Director (Senior Director), Regulatory Affairs in Durham, NC. This role requires a minimum of 8 years of regulatory...  ...industry and involves overseeing global regulatory strategies for drug development. The successful candidate will manage... 
    Senior
    Regulatory

    Shattuck Labs, Inc.

    Durham, NC
    2 days ago
  • $150k - $200k

     ...standards. Key responsibilities include managing resources, contributing to business development, and ensuring project deliverables meet regulatory requirements. Comprehensive benefits and a competitive salary range from $150,000 to $200,000/year are offered, alongside... 
    Senior
    Regulatory

    SSOE Group

    Durham, NC
    2 days ago
  •  ...minimum of 5 years experience in the pharmaceutical industry focusing on GMP. Responsibilities include mentoring project teams on regulatory standards, leading quality improvement efforts, and ensuring compliance through audits and assessments. Strong interpersonal and... 
    Senior
    Regulatory

    AstraZeneca

    Durham, NC
    2 days ago
  •  ...Shared Services North America, Inc. in North Carolina is seeking a Senior Due Diligence Specialist to conduct risk-based due diligence...  ...reviews of third-party partners. You will evaluate legal, regulatory, financial and reputational risks, and provide risk-based recommendations... 
    Senior
    Regulatory

    Grifols Shared Services North America, Inc

    Durham, NC
    2 days ago
  •  ...Summary You will lead Chemistry, Manufacturing and Controls (CMC) regulatory strategy for development and lifecycle activities, working with cross...  ..., paid holidays, vacation, and paid caregiver/parental and medical leave. Equal Opportunity Employer GSK is an Equal... 
    Senior
    Regulatory
    Work at office
    Local area
    Remote work
    Worldwide

    GlaxoSmithKline

    Durham, NC
    2 days ago
  •  ...company, is seeking an Associate Director for Medical Affairs to act as a key liaison in the...  ...of clinical information, and implement strategies in collaboration with colleagues. The...  ...project management, data analysis, and regulatory guidelines is essential. #J-18808-Ljbffr... 
    Senior
    Regulatory

    TSP, a Syneos Health company

    Durham, NC
    2 days ago
  •  ...Principal Medical Writer ViiV Healthcare, a global specialty HIV company, is seeking a Principal...  ...writing for complex clinical and regulatory projects. You will work closely with clinical...  ..., briefing documents, and submission dossiers. Manage end‑to‑end writing projects,... 
    Regulatory
    Local area
    Remote work

    ViiV Healthcare

    Durham, NC
    4 days ago
  •  ...ViiV Healthcare is seeking a Principal Medical Writer who will lead and deliver high-quality...  ...medical writing for complex clinical and regulatory projects. You will work closely with...  ...reports, briefing documents, and submission dossiers.Manage end-to-end writing projects,... 
    Regulatory
    Local area
    Remote work

    GlaxoSmithKline

    Durham, NC
    2 days ago
  • $107.9k - $172.64k

    ## Senior Strategic Advisor, Health Plan StrategyApplylocations:...  ...mission, vision and activate the strategy across multiple time horizons...  ...monitor relevant industry, regulatory, technology and market based...  ...the autonomy to do great work* Medical, dental, and vision coverage... 
    Senior
    Regulatory
    Work at office
    Local area
    Remote work
    Flexible hours
    2 days per week

    Blue Cross and Blue Shield of North Carolina

    Durham, NC
    2 days ago
  • $70.1k - $145k

     ...Syneos Health, Inc. in Morrisville, NC, is seeking a Senior Medical Writer to lead the writing of clinical and regulatory documents. This role requires expertise in FDA and ICH regulations and prior experience in the biopharmaceutical sector. Responsibilities include... 
    Senior
    Regulatory

    Syneos Health Inc

    Morrisville, NC
    3 days ago
  • ## Senior Manager, Systems Analysis LeaderApplylocations: Durham, NC: 900 Salem St, Smithfield...  ....****Senior Manager, Systems Analysis Leader**Are you ready to lead a team to...  ...rules and regulations of numerous self-regulatory organizations, including FINRA, among others... 
    Senior
    Regulatory
    Full time

    Soteria Reinsurance Ltd.

    Durham, NC
    22 hours ago
  •  ...You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects in the U.S. across...  ...origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under... 
    Regulatory
    Local area

    GlaxoSmithKline

    Durham, NC
    1 day ago
  • IQVIA LLC is seeking a Senior Medical Writer in Durham, North Carolina. The candidate will act as Lead Medical Writer on various projects, ensuring...  ...for contributing to innovative medical treatments while ensuring adherence to regulatory standards. #J-18808-Ljbffr IQVIA LLC
    Regulatory

    IQVIA LLC

    Durham, NC
    2 days ago
  • Atsena Therapeutics seeks an Associate Director / Director of Regulatory Strategy (Clinical & Nonclinical) to lead global regulatory strategy for gene therapy programs from preclinical to commercialization. You will guide nonclinical and clinical regulatory plans and serve... 
    Regulatory

    Atsena Therapeutics

    Durham, NC
    2 days ago
  • IQVIA Argentina is seeking a Principal for COA Strategy Consulting to lead client projects and business development in a collaborative environment. This role involves developing strategies for complex client needs and mentoring team members. The ideal candidate has over... 
    Senior

    IQVIA Argentina

    Durham, NC
    3 days ago
  • GlaxoSmithKline is seeking a Regulatory Strategy Lead in Durham, North Carolina, with responsibility for Chemistry, Manufacturing, and Controls (CMC) strategy. You'll collaborate with cross-functional teams to ensure timely access to medicines and compliance with regulatory... 
    Regulatory

    GlaxoSmithKline

    Durham, NC
    2 days ago
  • $130k - $180k

     ...communication skills. The ideal candidate will lead high-impact projects and act as a trusted advisor to clients, ensuring successful data strategies and implementations. Competitive compensation includes a salary range of $130,000 to $180,000, along with comprehensive benefits... 
    Senior
    Flexible hours

    Beghou

    Durham, NC
    2 days ago
  •  ...both internal and external audiences at all levels, including senior-level leadership • Organize, optimize and communicate progress...  ...subject matter expert for healthcare delivery transformation and strategy • Utilize expertise to identify operational improvements with new... 
    Senior
    Contract work

    Jobtailor

    Durham, NC
    3 days ago
  • Aerogen Pharma, located in Morrisville, NC, is looking for a Senior Manager, Regulatory Affairs. This role involves leading regulatory strategy and execution for biologic-device combination products, focusing on clinical development and compliance. The ideal candidate... 
    Senior
    Regulatory

    Aerogen Pharma

    Morrisville, NC
    3 days ago
  • Bioventus LLC. is seeking a Senior Regulatory Affairs Specialist in Durham, NC. In this hybrid role, you will author and submit key regulatory applications, ensuring compliance with standards for new and existing products. A Master’s degree and 3 years of experience in... 
    Senior
    Regulatory

    Bioventus

    Durham, NC
    2 days ago

Do you want to receive more vacancies?

Subscribe and receive similar vacancies to Senior Medical Writer Regulatory Dossier & Strategy Leader. Be the first to apply!