- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... reporting capabilities, incl. creating reports and dashboards of key regulatory data/metrics from across systems, leveraging technical ...role will need to partner closely with teams and senior leaders from across Regulatory Affairs, as… more
- Aequor (Newbury Park, CA)
- This will be a 100% remote role. The hiring manager confirmed they are looking for someone who works regular hours (7a-4p or 8am-5p etc)/ with EST timezone ... Sigma method and project management experience. The type of qualities/characteristics the hiring manager is looking for in candidates that will work best with their… more
- Novo Nordisk Inc. (Durham, NC)
- …the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead, drive & coach teams ... & oral communication skills & the ability to author scientific & technical reports is required Organization/Planning: Proven expertise in leading execution of a… more
- Merck & Co. (Rahway, NJ)
- …for assigned protocols and sites in a country.Under the oversight of the CRA manager or CRD, the person ensures compliance of study conduct with ICH/GCP and country ... requirements internally and externally. Acts as primary site contact and site manager throughout all phases of a clinical research study, taking overall… more
- Merck & Co. (North Wales, PA)
- …Trial Team (CTT)May work closely with the Medical Writer on clinical/scientific and regulatory documents and the Study Manager on study deliverables.May provide ... sciences, preferred. Required experience & skills: Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH) - Ability to manage multiple… more
- Novo Nordisk Inc. (Durham, NC)
- …& regulatory requirements in accordance with the Novo Nordisk Way. Relationships Senior Manager . Essential Functions Manage and guide team to maintain plans ... environment Champion for cGMP compliance, to include ensuring internal and external regulatory compliance of all site systems Ensure IT systems are available,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Visual Aids), display, mobile and social media, etc. Relationships Reports to the Senior Manager , Digital Content Delivery; Provides direct support to the ... the Manager will lead definition of business requirements and technical implementation plans in collaboration with cross functional partners and key… more
- Novo Nordisk Inc. (Durham, NC)
- … regulatory requirements in accordance with the Novo Nordisk Way. Relationships Senior Manager . Essential Functions Maintain plans to meet changes in customer ... accredited university required Master's degree in pharmaceutical, engineering, or other technical science field or equivalent combination of education & experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …business areas (Sales, Marketing, Clinical, TMPC, Med Affairs, and Regulatory Affairs) and support functions (IT, Finance, HR, and Legal).ResponsibilitiesTraining ... creation of training materials, particularly as it relates to both technical build and creative design.Support Compliance department in managing training logistics… more
- Tris Pharma (Monmouth Junction, NJ)
- …throughout company (ie, QA Operations, Quality Control (QC), Manufacturing, Operations, Technical Services, Senior Leadership, etc.) on deviations and PQC ... in Monmouth Junction, New Jersey, Tris has an immediate opening for a Manager , Quality Management Systems (QMS). Summary:The Manager , Quality Management Systems… more
- Novo Nordisk Inc. (Boulder, CO)
- …GMP manufacturing experience in the areas of biotechnology/pharmaceuticals. Relationships Senior Manager , Material Management. Essential Functions Manage ... support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …technology transfer activities in support of commercialization. Serve as a technical resource to improve product quality, reliability, and process capability. ... validation projects to ensure timely completionResponsible for drafting and providing technical guidance for the validation program, Policies and SOPs and other… more
- Novo Nordisk Inc. (Boulder, CO)
- …support analytical and process development, the CMC team works alongside Quality, Regulatory , Technical Operations and RNAi Early Development professionals at ... About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics, continuing its legacy as… more
- American Honda Motor Co Inc (Marysville, OH)
- …15 years as an attorney in commercial contracts* Proven knowledge of contractual, regulatory , and commercial lawOther Job-Specific Skills* Preferred: 5 - 10 years of ... achieving results and supporting others to achieve results, and legal technical knowledge. Decisions ExpectedTransactional matters: the Deputy General Counsel will… more
- Merck & Co. (Durham, NC)
- Job Description Job Description: The Senior Maintenance Shutdown Scheduler is a member of the Engineering, Maintenance and Site Services (EMSS) team providing ... by policies, procedures, and business plan; receives limited guidance from manager . Coordinate interactive planning sessions with site IPT's and contractors to… more
- Option Care Health (Tallahassee, FL)
- …to our customers, our teammates, and the patients we serve.Job Description Summary:The Senior Manager , Naven health Regulatory and Quality shall have ... manages the Quality Department and all Quality Nurses reporting directly to the Senior Manager of Quality and Regulatory .Job Description: Job… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and leadership for the investigations management system. Working closely with the Quality Senior Manager , this position will ensure alignment with all applicable ... Associate Director for Operations Compliance and Investigations Managementas part of the Technical Operations team based in Raritan, NJ. Role Overview The Associate… more
- DCS Corp (Bedford, MA)
- DCS Corp has an exciting opportunity for a Senior Program Manager providing support to the Air Force Life Cycle Management Center/PEO Digital Directorate ... and development efforts. Provide program level acquisition support to the Program Manager and Integrated Product Team Leads by helping guide successful program… more
- Arthrex (Naples, FL)
- …and medical education in orthopedics. Arthrex is actively searching for a Sr. Project Manager , Program Manager - Regulatory Affairs who is responsible for ... Manages subsidiary-based and global projects/programs within the scope of the Regulatory Affairs. Develops project objectives by reviewing project proposals and… more
- Fidelity TalentSource LLC (Greenwood Village, CO)
- Job Description:The Senior Manager Data Strategy (Quant Services) position is responsible for providing guidance and performing business, systems & data analysis ... Strategy, Global Data Services and Portfolio Engineering teams to insure timely remediation. The Senior Manager Data Strategy will play an important role in the… more
