- Novo Nordisk Inc. (Plainsboro, NJ)
- …Supervise designated personnel. Relationships Report to the Director/Associate Director/Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...area preferred Good interpersonal skills; ability to interact with staff on all levels Knowledge of diabetes and diabetes… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized ... solutions to the world.Looking for someone with a growth mindset. The Director, Regulatory Affairs Liaison is responsible for:Developing regulatory strategy… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders. SummaryThis position serves as the Global Regulatory Affairs (GRA) Labeling Strategy expert to the Global Product Team ... point of contact for cross-functional teams on RA labeling issues. Collaborate with Regulatory Affairs and Labeling colleagues in other regions, including Japan,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Clinical Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams. Will be interfacing with both internal ... Operations, Non-Clinical Research, Medical Writing, Program Management, CMC and Regulatory Affairs teams to deliver and drive...support of the development objectives for DCR-PHXC and assist Regulatory Strategy staff in the compilation of… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …cross-functional project teams, including Clinical Development, Clinical Operations, Biometrics, and Regulatory Affairs personnel to manage preparation of the ... written deliverables that support the clinical development and regulatory requirements of a clinical program. The Director will provide high level strategic input… more
- Merck & Co. (Rahway, NJ)
- …with staff , colleagues across CMC development, Quality Assurance, and CMC Regulatory Affairs as needed to ensure understanding of needs, proper ... and scientists within Discovery, Pre-clinical Development, Manufacturing, Quality Assurance and Regulatory groups and provides technical insights and support for our… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborate with RD leaders in Clinical Operations, Biostatistics and Data Management, Regulatory Affairs , and other RD functions to ensure effective delivery ... Corporate Business Management)Partner and collaborate with global marketing, global medical affairs , global payers and access and commercial business units to ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in medical review processes and is also an integral member of the Medical Affairs Team. This position plays a key role in driving a unified medical voice ... mentor to junior colleagues- Serve as integral member of the Medical Affairs Teams for assigned TA.Proactively lead effective coordination and alignment between… more
- Aequor (Thousand Oaks, CA)
- …? Serve as the primary interface with Clinical Development, Quality, Biostatistics, Regulatory Affairs , Corporate Planning, and Operations to ensure coordination ... depending on the need. Ideal candidate: Warehouse planning. Working with warehouse staff planning internally between two sites. Planning experience but interested in… more
- Merck & Co. (Rahway, NJ)
- …regional and local operations, EU Clinical-Development, Pharmacovigilence, Global Medical Affairs to align on key issues/decisions-across the trials. Consult with ... the TA Head or CRD.Requires strong understanding of local regulatory environment.-Strong scientific and clinical research knowledge is required.-Strong understanding… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etcQualifications: Successful candidates will be able ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this workPossesses in-depth… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... tables, listings, and figures (TLFs) needed for clinical study reports and regulatory submissions, as well as in-house validation of this work. Possesses in-depth… more
- Stryker (Fremont, CA)
- …our award-winning organization by visiting stryker.com We are currently seeking a **Senior Staff Regulatory Affairs Specialist** to join our Neurovascular ... to learn and looks to continuously improve. **What you will do** As the **Senior Staff Regulatory Affairs Specialist** , you will be core team member of new… more
- Stryker (Cary, IL)
- …annually. More information is available at www.stryker.com We are currently seeking a ** Staff Regulatory Affairs Specialist** to join our **Medical ... for sales, management and leadership teams. **What you will do** As the ** Staff Regulatory Affairs Specialist** , you will provide information used to… more
- Stryker (Allendale, NJ)
- …More information is available at www.stryker.com We are currently seeking a **Senior Staff Regulatory Affairs Specialist** to join our **Spine Division** ... and meets regulations and expectations. **What you will do** As the Senior Staff Regulatory Affairs Specialist, you will work to maintain medical devices on… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- **Job Description Summary** The Staff Regulatory Affairs Specialist will work in BD Medical - Pharmaceutical Systems Business Unit taking on a lead role at ... claims and communication, Advertising/promotional materials, and labeling + Conduct trainings on regulatory issues for staff and for business customers (eg,… more
- STERIS (Pomaria, SC)
- …as assigned, under the guidance and direction of his/her manager and other senior Regulatory Affairs staff . General Duties + Responsible for maintaining ... Regulatory Affairs Intern Req ID: 43993...in the International markets, working with STERIS International Registration staff to identify requirements in other targeted markets, and… more
- Astellas Pharma (Northbrook, IL)
- …May manage one or more direct report. Recruits and hires, trains and develops regulatory affairs staff in advertising and promotion review and contributes ... according to approved company processes. Responsible for the training of regulatory staff , as required. **Essential Job Responsibilities:** Conducts review… more
- Cook Medical (Bloomington, IN)
- …engineering procedures and project outputs with regulatory requirements- Assist various Regulatory Affairs staff with technical assessment and writing of ... Overview The Regulatory Engineer provides technical support to Regulatory Affairs for the development of regulatory documentation for compliance with FDA… more
