- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory Affairs … more
- Merck & Co. (Rahway, NJ)
- …Trial Support, Cross-Functional Teamwork, Data Analysis, Hematology, Intellectual Curiosity, Medical Research, Oncology, Regulatory Affairs Compliance, ... efficacyWork closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs , General Medicine, will contribute to the mission and vision of the Global ... Regulatory Affairs and Clinical Safety (GRACS) function...cross-functional impact, including drug device/combination products and software as medical device platforms.- Reviews and resolves issues that span… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …annual performance cycle. Relationships Reports to Executive Director or Vice President Medical Affairs . Has direct supervisory responsibility for field based ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the global regulatory ... At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides...industry experience with a minimum of 10 years direct Regulatory Affairs experience in the biotech/biopharmaceutical industry.… more
- Eisai, Inc (Nutley, NJ)
- …your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and execution ... of Global Medical Affairs /MSL training and continued education plans...credibility and ensure operational excellence (20%) Ensure compliance with regulatory and other ethical guidelines relevant to the pharmaceutical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and… 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 ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Novo Nordisk Inc. (WA)
- …line with Corporate Tax, as well as other Market Access & Public Affairs teams, Medical , Legal, Compliance, Communications and other key stakeholders locally ... and gathering insights from other departments (Corporate Tax, MA, Comm'l BUs, Medical , Regulatory , Legal, etc) Assigned policy areas may include, but… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …with Brand teams, other functional teams in NNI (including MAPA), including marketing, medical , R&D, regulatory affairs , finance, NNGlobal, and other ... also eligible to participate in Company employee benefit programs including medical , dental and vision coverage; life insurance; disability insurance; 401(k) savings… more
- Lexington Medical (Bedford, MA)
- … Affairs , or other technically related field. 5-8+ years of experience in medical device regulatory affairs , including prior 510(k) submission and EU MDR ... in a growing company. We are seeking a Senior Regulatory Affairs Specialist to develop, lead and...expansion. This is a terrific opportunity for an experienced medical device regulatory professional to grow with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence & Analytics function, responsible for ensuring ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...with relevant regulations. This role will work with Global Regulatory Affairs and cross-functional teams (eg, Quality,… more
- Stryker (Mahwah, NJ)
- …3+ years of experience in an FDA regulated industry 2+ years of experience in medical device regulatory affairs Thorough understanding of FDA, Europe, and ... Weston, FL. What you will do As the Senior Regulatory Affairs Specialist , you will support...certification or Advanced Degree (Masters in Regulatory Affairs ) Previous experience with Class II/III medical … more
- Gilead Sciences, Inc. (Santa Monica, CA)
- …Ensure compliance with all regulatory requirements and internal policies for medical affairs activities. Support regulatory submissions, including safety ... a Senior Medical Manager to support US Medical Affairs . As a Senior Medical...and scientific communities. Cross-Functional Collaboration: Partner closely with Commercial, Regulatory , and Clinical Development teams to ensure medical… more
- Medtronic (Irvine, CA)
- …of relevant experience Or advanced degree with a minimum of 2 years of experience in medical device regulatory affairs This is not a remote position Nice To ... Have 4 years of experience in medical device regulatory affairs Excellent technical knowledge of medical products and understanding of relevant… more
- Sun Pharmaceutical Industries (Princeton, NJ)
- …anage HEOR projects across product lifecycles, collaborating with cross-functional teams (clinical, medical affairs , regulatory ) to support enterprise needs. ... as a subject matter expert within the enterprise, working with teams across medical , clinical, regulatory , and commercial functions to support and lead business… more
- Eisai, Inc (Nutley, NJ)
- …execution of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These ... be used in external interactions with KOLs (ie by MSLs), advisory boards, internal medical affairs strategic communication tools (ie medical narratives) and… more
- Legend Biotech USA, Inc. (Baton Rouge, LA)
- …Biotech is seeking Sr. Medical Science Liaison (South Central) as part of the Medical Affairs team based in TN, KY, AR, LA, or MS. Role OverviewAs part ... of the US Medical Affairs team, the Senior ...hired MSLs.Fully understand and apply MSL SOP's/guidelines and company HCC/ Regulatory /Legal guidelines.Requirements2-3 years relevant MSL work experience in therapeutic… more
- Omnicom Health (New York, NY)
- …medicines. We've created a unique model of four powerhouses- Commercial & Marketing, Medical Affairs , Publications, Regulatory - that enables hyperconnected, ... communications partner for pharma and biotech that accelerates the impact of medical science. HCG boldly defines the healthcare communications landscape at the… more
