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Regulatory writing senior manager Jobs in South San Francisco, CA

209 Jobs

  • 4.0
    Genentech – South San Francisco, CA
    $117k-$209k(Glassdoor est.)
    NEW
    and close cooperation with regulatory authorities. The newly created role of Manager / Sr. Manager, Science Communications reports… function (PD comprises 10 global functions). The Manager / SeniorManager, Science Communications will work closely with fellow…
  • 4.5
    Advanced Clinical – San Francisco, CA
    $87k-$126k(Glassdoor est.)
    NEW
    responsible for assembling and reviewing regulatory dossiers prior to review by seniorregulatory management May select, develop, and… skilled professional to join a well-known clients team as Manager, Regulatory Affairs. Their work will have a direct impact on not…
  • 4.0
    Sutro Biopharma – South San Francisco, CA
    EASY APPLY
    $92k-$128k(Glassdoor est.)
    4 days ago 4d
    in the preparation of regulatory submissions and presents validations in respective SME areas to regulatory authorities during routine… ’s cGMP Manufacturing Facility in accordance with current regulatory and industry standards. This individual can execute validation…
  • 4.0
    Genentech – South San Francisco, CA
    5 days ago 5d
    interpretation and clinical relevance Sound understanding of regulatory guidelines for drug development Proficient computer skills… project management skills Strong interpersonal, verbal and writing communication and influencing skills Proven track record…
  • 4.2
    Ascent Services Group – Brisbane, CA
    9 days ago 9d
    SeniorManager/ManagerRegulatory Affairs (CAR-T) San Francisco Bay Area or Seattle, WA Permanent Responsibilities:… Providing input to regulatory submission strategy, preparing regulatory submission documents, and reviewing regulatory submissions for…
  • 3.1
    Five Prime Therapeutics, Inc. – South San Francisco, CA
    $84k-$118k(Glassdoor est.)
    18 days ago 18d
    motivated and ambitious individual to join the Medical Writing group under Regulatory Affairs. The individual will work closely with cross-functional… contractors to perform medical writing duties. This position reports to the Vice President of Regulatory Affairs. Responsibilities…
  • AstraZeneca Pharmaceuticals LP – Redwood City, CA
    NEW
    clinical and regulatorywriting resource and activities. The Director, Head of Medical Writing leads the writing/manages the resources… summaries and overviews, and any other regulatory document required for submission Provides senior oversight of documents quality and…
  • 4.4
    Audentes Therapeutics – South San Francisco, CA
    $105k-$225k(Glassdoor est.)
    17 days ago 17d
    years (Associate Director)/6-8 years (SeniorManager) of demonstrated experience in a senior position that includes application deployments… business, compliance and regulatory requirements, as well as operational service level agreements. Manage all activities of internal…
  • 4.2
    Ascent Services Group – Brisbane, CA
    7 days ago 7d
    Associate Director/SeniorManagerRegulatory Affairs (CAR-T) San Francisco Bay Area or Seattle, WA Permanent Responsibilities… Providing input to regulatory submission strategy, preparing regulatory submission documents, and reviewing regulatory submissions for…
  • 3.5
    Cytokinetics – South San Francisco, CA
    $91k-$128k(Glassdoor est.)
    10 days ago 10d
    The Senior/Principal Medical Writer will be responsible for collaborating with a number of departments in writing, reviewing and… INDs and NDAs. While the focus will be in the clinical and regulatory areas, the ability to assist with preparation of CMC documentation…
  • 3.6
    AstraZeneca – Redwood City, CA
    $118k-$171k(Glassdoor est.)
    NEW
    clinical and regulatorywriting resource and activities. The Director, Head of Medical Writing leads the writing/manages the resources… nonclinical and regulatory documents and annual reports is a plus Recent and significant experience in writing of regulatory documents…
  • 3.7
    Veracyte – South San Francisco, CA
    $143k-$216k(Glassdoor est.)
    28 days ago 28d
    The Position: Reporting to the CIO, the SeniorManager of Information Technology will provide overall support and management… Implementing and monitoring process controls to address regulatory requirements. Coaching and mentoring team of professionals…
  • 4.0
    Genentech – South San Francisco, CA
    $81k-$127k(Glassdoor est.)
    4 days ago 4d
    . Notify Senior Management of potential quality or regulatory issues that may impact product quality or regulatory compliance… linked to business and site processes. Monitor emerging regulatory trends to assess impact on the business and influence policy…
  • 3.4
    Exelixis – South San Francisco, CA
    NEW
    health authorities including regulatory filing documentation and study close-out reports. Helps to write and/or review product specific… technical principles, theories, concepts and techniques. Leads or manages the work of others by providing guidance to subordinates or…
  • 3.6
    MERCK & COMPANY INC. – South San Francisco, CA
    6 days ago 6d
    execution; clinical site training/monitoring; medical and regulatorywriting Required Skills: Understanding of clinical research… Ability to manage complex operations and projects under accelerated timelines Scientific, medical and/or safety writing and reporting…
  • 3.1
    Gilead Sciences – Foster City, CA
    $108k-$167k(Glassdoor est.)
    4 days ago 4d
    relevant experience in a medical writing/clinical submissions environment preparing documents for regulatory submissions. Position… variety of regulatory submissions across all therapeutic indications. Functions as the Quality Lead for complex regulatory deliverables…
  • 4.4
    Audentes Therapeutics – South San Francisco, CA
    8 days ago 8d
    Design, supervise, and manage in-house bioanalytic assays (GLP and non-GLP) for inclusion in regulatory submissions and assessment… clinical development, project management, biostatistics, and regulatory affairs departments. Integrate quality standards to ensure…
  • 4.0
    Genentech – South San Francisco, CA
    $225k-$350k(Glassdoor est.)
    18 days ago 18d
    data/information: scientific/clinical, safety, legal/regulatory, medical writing, analytics, etc. Comprehensive understanding of… Hiring / Find A Job Senior Medical Director/Medical Science Director, Rare Disease USMA South San Francisco,…
  • 4.2
    Portola Pharmaceuticals, Inc. – South San Francisco, CA
    $159k-$216k(Glassdoor est.)
    28 days ago 28d
    packages Negotiate and manage the budget and payments for investigative sites, if applicable Write or contribute to preparation… advances to address significant unmet needs. The Senior Clinical Trial Manager will be responsible for the operational management…
  • 4.0
    Genentech – South San Francisco, CA
    $105k-$156k(Glassdoor est.)
    HOT
    services, Data Services, and medical writing/regulatory services. In addition, the Category Manager maintains category specific knowledge… and interpersonal skills to be able to engage and manage expectations of senior management, particularly Finance and R&D Ops. Fluent…
  • 3.4
    Exelixis – South San Francisco, CA
    $106k-$136k(Glassdoor est.)
    10 days ago 10d
    quality control of statistical submission components to regulatory agencies. May partner with biostatisticians and clinical data… experience desirable. Ability to communicate verbally and in writing in a clear and timely manner. Experience in Biotech/Pharmaceutical…
  • 3.4
    FTI Consulting – San Francisco, CA
    $73k-$106k(Glassdoor est.)
    NEW
    organizations manage change, mitigate risk and resolve disputes: financial, legal, operational, political & regulatory, reputational… • Strong written and verbal communication skills, as report writing is required to serve TAS clients. • The ability to conduct…
  • 5.0
    Assembly Biosciences, Inc. – San Francisco, CA
    $95k-$224k(Glassdoor est.)
    NEW
    and manage activities/timelines consistent with overall Project Team strategy and corporate goals Write/review regulatory documents… independently write technical reports and regulatory documents (suitable for submission to FDA and other regulatory authorities)…
  • 4.2
    Ascent Services Group – San Rafael, CA
    8 days ago 8d
    SeniorManager International Regulatory Affairs San Rafael, CA Permanent Responsibilities: Manage a US-based… APAC regions. Manage and mentor associate/senior associate/manager-level direct reports. Provide regulatory support to team…
  • 3.1
    Ultragenyx Pharmaceutical – Brisbane, CA
    $107k-$164k(Glassdoor est.)
    4 days ago 4d
    Position Summary Ultragenyx is looking for an experienced SeniorManager of CMC Quality Control (QC) with the passion and creativity… develop great medicines for rare and ultra-rare diseases. The SeniorManager will be responsible for all aspects of quality control in…
  • 4.6
    DocuSign – San Francisco, CA
    EASY APPLY
    $169k-$246k(Glassdoor est.)
    HOT
    visibility, transparency, production, brand governance and regulatory compliance Perform annual content audits and oversee ongoing… storyteller with excellent communication skills and impressive writing abilities A track record of building and leading marketing…
  • 4.5
    Achaogen – South San Francisco, CA
    $88k-$164k(Glassdoor est.)
    30+ days ago 30d+
    Position Summary: The Manager / SeniorManager of Clinical Microbiology will represent the microbiology function on one or… projects. Experience with grant application writing. Excellent scientific writing, presentation and interpersonal communication…
  • 3.1
    Gilead Sciences – Foster City, CA
    $143k-$195k(Glassdoor est.)
    23 days ago 23d
    Under the direction of a seniorRegulatory Project Manager the Senior Associate in Regulatory Project Management will develop… coordination of activities via the Regulatory Submission Team. The Senior Associate in Regulatory Project Management will foster…
  • 4.0
    Genentech – South San Francisco, CA
    $99k-$144k(Glassdoor est.)
    14 days ago 14d
    internal uptake and implementation of compliance, quality, and regulatory changes, and facilitating interactions with key partners across… relate to quality and compliance Understands life sciences regulatory and compliance landscapes Impeccable work ethic and commitment…
  • 4.2
    Ascent Services Group – San Rafael, CA
    6 days ago 6d
    Director/Senior Director of Regulatory Global Labeling San Rafael, CA Permanent The Director/Senior Director of Regulatory… responsible for regulatory compliant, competitive, and up-to-date labeling. The Director/Senior Director of provides regulatory labeling…
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