- Daiichi Sankyo, Inc. (Bernards, NJ)
- …well as other research areas centered around rare diseases and immune disorders.Summary The Manager , Regulatory Affairs - Regulatory Project Management ... to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class...provides planning and coordination supports for global and US regulatory activities. The Manager RPM is responsible… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of any required documents to FDA.RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team ... About the Department The Clinical, Medical and Regulatory (CMR) department at...Are you ready to make a difference? The PositionThe Regulatory Affairs Therapeutic Area Postdoctoral Fellowship is… more
- Eisai, Inc (Exton, PA)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... Job Summary Implements global chemistry, manufacturing and control (CMC) regulatory strategies throughout the lifecycle of pharmaceuticals. Coordinates the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Medical Affairs Postdoctoral Fellowship is a one-year, experiential program based in ... About the Department The Clinical, Medical and Regulatory (CMR) department at...pharmaceutical industry. The fellow will provide assistance to the Medical Affairs department at Novo Nordisk Inc.… more
- PSG Global Solutions (Cambridge, MA)
- Description We're looking for a Manager of Regulatory Affairs , working in Biotechnology/ Medical Devices industry in Cambridge, Massachusetts, United ... States. Works with Regulatory Affairs management to define regulatory strategy and to compile and submit, in a timely manner, regulatory documents… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and the Oncology Business Unit globally; promote a quality culture within Global Medical Affairs Quality Assurance by providing study team support to uphold ... GPV, GDP, and adherence to safety requirements are adequately considered for all Medical Affairs programs. Interact with legal and compliance as required.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Key internal stakeholder relationships include Strategic Operations (focus on Patient Safety), NNI Medical Affairs , Global Medical Affairs , Health ... About the Department The Clinical, Medical and Regulatory (CMR) department at...Global R&D, US Competitive Intelligence, Managed Markets, Clinical Insights, Medical Affairs , Scientific Center of Excellence) and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and manuscripts, when requested Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs Physical Requirements 20-30% ... About the Department The Clinical, Medical and Regulatory (CMR) department at...certain instances, at the discretion of Executive Director of Medical Affairs . Assists the Senior Medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in the Oncology Business Unit/US Oncology Business Division (including, for example, Medical Affairs , Sales, Marketing, Market Access, etc.) including, but not ... Business Division of the Company (including, for example, Market Access, Sales, Marketing, Medical Affairs ) as well as DSI employees performing Global roles in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Rare Value Communications & Pricing. Interacts internally with team representatives from Public Affairs , PCOR, Finance, Brands, Medical Affairs , HEOR, Future ... About the Department Novo Nordisk's Market Access and Public Affairs team engages diverse stakeholders across political and healthcare landscapes to forge solutions… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …functional areas during their rotations. Additional key internal relationships may include Medical Affairs , Regulatory Affairs , Marketing, Learning ... Essential Functions Fellow will collaborate with cross-functional areas including Medical Affairs , Regulatory Affairs...an understanding of the role and responsibilities of a Medical Information Manager in a pharmaceutical industry… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …access, commercial effectiveness, sales, medical /CMR, legal, compliance, and regulatory . Other internal relationships include Public Affairs , Government ... up Must have solid understanding of the pharmaceutical marketplace including legal, medical , regulatory and clinical processes Develops accurate short- and… 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 ... Interactions: Leads US FDA/EU EMA interactions with support from higher-level manager . Regulatory Knowledge: Demonstrates expert knowledge of US/EU regulatory… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Professional Education throughout the one-year program. Additional key internal relationships include Medical Affairs , Marketing, Legal and Regulatory ... projects.The fellow will have regular contact with cross-functional areas, including Marketing, Medical Affairs , Medical Operations and Legal. This… more
- Tris Pharma (Monmouth Junction, NJ)
- …collaborative and compliant communication between marketing and other cross-functional teams (ie, Medical Affairs , Sales, Regulatory Affairs , Operations, ... and related communications and programs are in full compliance with Medical , Legal, Regulatory and Corporate guidelines; Establishes, oversees implementation,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …coordination of data collection and trend analysis as requested by QA and Regulatory Affairs including the annual report required for maintenance of the ... ensuring consistent quality standards are maintained.Key Responsibilities Support area Manager and work closely with investigators to ensure investigations are… more
- Hinge-Health (San Francisco, CA)
- …60601.Ability to engage, coach, and teach cross-functional team members regarding Regulatory Affairs and medical device requirements.Preferred ... About the RoleIn this role as a Regulatory Affairs Specialist, you will have...pursuing courses of action necessary to obtain and expand regulatory approval of Hinge Health's medical device… more
- Vertex Pharmaceuticals Incorporated (Boston, MA)
- …Global, International Medical Affairs organizations, US Public Affairs , Corporate Communications, Legal, Compliance (OBIE), Regulatory , Research & ... Job DescriptionGeneral Summary:The Medical Affairs Medical Director,...flexible and reactive to situations.Knowledge of national healthcare and regulatory environments.Excellent understanding of the reimbursement mechanisms in location… more
- Vertex Pharmaceuticals (Boston, MA)
- … Medical Strategy. Additionally, this role interacts regularly with multiple Global Medical Affairs functions, including regional and country medical ... Development, Biometrics, and Safety. Key Responsibilities: Develops Global and North America medical affairs plans, including launch and Life Cycle Management… more
- Xenon Pharmaceuticals Inc. (Boston, MA)
- …as well as with key internal stakeholders such as Finance, Clinical Operations, Regulatory Affairs , and Quality Assurance. This position reports to the Senior ... an exciting product pipeline to address indications with high unmet medical need, including epilepsy and depression. Our flagship azetukalner program represents… more
