- Legend Biotech USA, Inc. (Raritan, NJ)
- …of the Quality team based in Raritan, NJ. Role OverviewThe Quality Compliance Manager is responsible for regulatory compliance supporting the production of ... manage audit responses and observation resolution.Drive site compliance to regulatory , enterprise, and global requirements through building positive relationships… more
- Merck & Co. (Durham, NC)
- …to support these initiatives. The position requires strong leadership, technical writing , and problem-solving skills.- You will lead and/or support critical project ... level. Collaborates with Operations, Technology and Quality to author regulatory inspection observation responses and completes remediation projects, as required.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.Drug Development Strategy: Provides input to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to… more
- Teva Pharmaceuticals (Parsippany, NJ)
- …level. Guides/oversees medical writers; considered a proficient manager with regulatory medical writing expertise. Considered an internal expert in ... Director, Therapy Area Head, Global Regulatory Medical Writing (USA, Remote) Date: Dec 16, 2024 Location: Parsippany, United States, New Jersey, 07005… more
- Teva Pharmaceuticals (Mason, NH)
- …to make a difference with. **The opportunity** As a **Senior Manager in Global Regulatory Medical Writing ** , you will write and edit clinical ... preparation. + Recognized as a competent manager with advanced expertise in regulatory medical writing . + Skilled in writing and editing various… more
- Teva Pharmaceuticals (West Chester, PA)
- …to make a difference with. **The opportunity** As a ** Manager in Global Regulatory Medical Writing ** , you will write and edit high-quality clinical ... Manager , Medical Writing (Remote,...documents include the proper content and context (from a regulatory medical writing perspective)and clear… more
- Teva Pharmaceuticals (Parsippany, NJ)
- Sr Director, Global Regulatory Medical Writing & Data Transparency Date: Dec 28, 2024 Location: Parsippany, United States, New Jersey, 07054 Company: Teva ... difference with. **The opportunity** The Senior Director in Global Regulatory Medical Writing & Data...for all projects. + Provide mentoring and proficiency to manager -level direct reports. Location: This is a hybrid opportunity… more
- J&J Family of Companies (Spring House, PA)
- …and retinal disease. We are recruiting for an Associate Director to join the Regulatory Medical Writing team to support the Immunology therapeutic area. ... Immunology programs. This role will report directly to the Regulatory Medical Writing Delivery Unit...partners to strengthen coordination between departments. As a people manager : + Leads and is accountable for direct reports.… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … content that is used for a variety of purposes, including critical regulatory submissions. Medical Writing collaborates cross-functionally to advance ... for a senior level medical writer (Senior Manager , Medical Writing , Oncology) to...products or projects. You will represent Medical Writing on relevant product, project, and/or regulatory … more
- BeiGene (San Mateo, CA)
- Job Summary: The Senior Manager , Medical Writing is responsible for writing , editing, and formatting clinical regulatory documents that conform to ... of INDs, NDAs, MAAs and other regulatory submission documents. The Manager , or Senior Manager , Medical Writing is also responsible for mentoring… more
- J&J Family of Companies (Spring House, PA)
- …Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team is recruiting for a Senior Manager . This position will support ... on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or...writing experience is required. + As a people manager , at least 2 years of people management experience… more
- Olympus Corporation of the Americas (Westborough, MA)
- …entity other than @Olympus.com, it is likely not legitimate._ **Job Description** The Regulatory Affairs (RA) Program Manager Digital Strategy is responsible for ... comparable required + Minimum of 5-7 years experience in Regulatory Affairs in Medical Device Industry with...on multiple parties at the same time. + Excellent writing and verbal skills **Why join Olympus?** _We offer… more
- Cardinal Health (Columbus, OH)
- …clinical operations, project management, medical affairs, legal, medical writing , nonclinical, and quality teams to ensure regulatory compliance in ... and interactions with regulatory authorities, preferred. + Proficiency in regulatory affairs software, writing software, and electronic eCTD submission… more
- Olympus Corporation of the Americas (Westborough, MA)
- …other than @Olympus.com, it is likely not legitimate._ **Job Description** Assist the Manager , Regulatory Affairs in obtaining approval to market Olympus ... and future approvals to management. **Job Qualifications** **Required:** + Regulatory affairs experience in the Medical Device...with BS/BA, or 7 years with MS preferred]. + Regulatory affairs experience in writing US submissions… more
- Harvard University (Cambridge, MA)
- …Office Location:USA - MA - Boston Business Title:Biostatistician/Statistical Project Manager for Regulatory Submission StudiesSub-Unit: Appointment End ... attendance at professional meetings. CBAR is looking to hire a Biostatistician/Statistical Project Manager for Regulatory Submission Studies to act as a senior… more
- Abbott (Pleasanton, CA)
- …mothers, female executives, and scientists **The Opportunity** We are seeking a ** Regulatory Affairs Manager ** to join Abbott's Heart Failure Division on-site ... CA. As an individual contributor, the function of a Regulatory Affairs Manager is to combine knowledge...medical fields. + Advanced degree + 8 years' Regulatory experience + Experience working in a broader enterprise/cross-division… more
- HCA Healthcare (Englewood, CO)
- …Ability to effectively communicate both verbally and writing with hospital, medical staff and regulatory bodies. Excellent computer skills in Word, EXCEL, ... the range. **Introduction** We are seeking a Quality and Regulatory Manager with HCA HealthONE Swedish to...colleagues. The available plans and programs include: + Comprehensive medical coverage that covers many common services at no… more
- Vera Therapeutics (Brisbane, CA)
- Job Title: Associate Director, Medical Writing Location: Brisbane, CA About Us: Vera Therapeutics (Nasdaq: VERA), is a late-stage biotechnology company focused ... suffering from immunological diseases. Position Summary: Reporting to the Senior Director, Medical Writing , the Associate Director, Medical Writing… more
- University of Michigan (Ann Arbor, MI)
- Regulatory Project Manager Apply Now **How to...to regulatory issues in product development 5% Medical Writing and Editing: + Creating and revising ... medical device to ensure clinical research excellence and regulatory compliance, as set forth by the UM and...employer. **Job Detail** **Job Opening ID** 257783 **Working Title** Regulatory Project Manager **Job Title** Research Compliance… more
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