- Eisai, Inc (Nutley, NJ)
- …of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include ... interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and other internal medical… more
- Merck & Co. (North Wales, PA)
- …resides in the V&I organization, which includes Global Medical and Scientific Affairs as well as Outcomes Research, and will support Pneumococcal Vaccines.Under the ... guidance of a senior leader, this position supports value evidence outcomes research...is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial, and country affiliates and… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/Associate Director, has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- Merck & Co. (North Wales, PA)
- …incumbent is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates and may ... develops value evidence strategies for in-line and pipeline products. Obtains senior management approval of evidence generation plans. Provides outcomes research… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international ... 3 days per week) based in Marlborough, MA. Provides technical guidance and regulatory training/mentoring to other Regulatory Affairs employees and… more
- Cleerly (Denver, CO)
- …be listed as requirements in the job description. About the Opportunity As Principal Regulatory Affairs Specialist, you will provide regulatory support and ... and regulatory compliance issues. Mentorship & Development: Mentor and develop senior regulatory professionals, guiding them through complex regulatory … more
- U-Haul (Phoenix, AZ)
- …educational experience. Experience: 1-2 years of experience in insurance compliance, regulatory affairs , actuarial support, or operations (Med Supp experience ... This role provides an opportunity to grow into a Regulatory Compliance Manager or Senior Compliance Analyst...Holding Company, and its family of companies including U-Haul International , Inc. ("U-Haul"), continually strives to create a culture… more
- ADC Therapeutics SA (New Providence, NJ)
- …Development, GMP Quality Assurance, Biostatistics, Pharmacovigilance, Clinical Supply Chain, Regulatory Affairs , Legal, and Executive Leadership to support ... and CAPA Effectiveness. * Regulatory Strategy and Compliance: Collaborate with regulatory affairs and clinical operations to align quality assurance… more
- Merus (Cambridge, MA)
- …for the company's medical writing activities, ensuring alignment with clinical development, regulatory affairs , and overall business goals. Define and implement ... Senior Director, Medical Writing Department: Clinical Operations Employment...document revision, QC, and finalization. Collaborate with clinical development, regulatory affairs , biometrics, and related cross-functional teams… more
- Dexcom, Inc. (San Diego, CA)
- …interfaces. (Internal examples: Supplier Quality, Quality, Engineering, Manufacturing, Regulatory Affairs , Receiving Inspection. External examples: Suppliers). ... health on a global scale stands before us. Meet the team: The Senior level Supplier Quality Engineer engages suppliers in three fundamental means: Supplier… more
- Stony Brook Medicine (Stony Brook, NY)
- …spectrum of issues relating to higher education, including research misconduct, international affairs , academic/affiliation and other agreements, and responding ... spectrum of issues relating to higher education, including research misconduct, international affairs , academic/affiliation and other agreements, and responding… more
- Elliquence (Baldwin, NY)
- …and risk management plans. Act as a liaison between R&D, quality assurance, regulatory affairs , manufacturing teams as well as external suppliers/ vendors to ... files, and verification/validation protocols) for regulatory submissions. Work closely with regulatory affairs to prepare submissions for FDA 510(k) or other… more
- MUFG Bank, Ltd. (Irving, TX)
- …Strong and demonstrable interest in foreign policy, national security, and international affairs . Ability to manage competing priorities, work independently ... be a sanctions regulations subject matter expert supporting GSCD's Regulatory Advisory functions across MUFG Bank, globally. The GSCD...as well as with peers and senior management in order to deliver solid results. Desire… more
- Abbott (Pleasanton, CA)
- …related field Eight (8) years of Quality Systems, Quality Assurance and/or Regulatory Compliance/ Affairs experience in medical device manufacturing or other ... You'll also have access to: Career development with an international company where you can grow the career you...health and get on with their lives. As a Senior Quality Compliance Manager, the individual will play a… more
- Abbott (Boston, MA)
- … Senior Management, Marketing, Training & Education, Research & Development, Regulatory & Clinical Affairs , Reimbursement, Customer Service, and Technical ... and live a full life. You'll also have access to: Career development with an international company where you can grow the career you dream of . Employees can qualify… more
- Solutus Legal Search (Los Angeles, CA)
- …a core member of the leadership team and will be responsible for all legal affairs of the Company. This person will lead innovation in the department to facilitate ... mentality around growth in a dynamic environment) who will collaborate with other senior leaders to accelerate the growth and evolution of the Company. The ideal… more
- Ascendis Pharma (Palo Alto, CA)
- …days per year domestically and internationally + Broad experience in Regulatory Affairs , working directly with FDA and international agencies with focus on ... we're advancing programs in Endocrinology Rare Disease and Oncology. The Sr. Director, Regulatory Affairs will serve as the therapeutic area head for assigned… more
- Danaher Corporation (Boston, MA)
- …Business Syste m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is ... and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will...internal procedures are updated to reflect evolving US and international regulations. + Assess the impacts of relevant drug… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …position to act as a team member in the product manager area of Regulatory Affairs (Biopharma) supporting global submissions for various areas of the business. ... Specialist I_** **Primary responsibilities for role:** + Act as Regulatory Affairs representative for specified key products/facilities/equipment. + Prepare… more
