- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders.SummaryThe Associate Director , Regulatory Operations - Dossier Planning ... INDs, original and supplemental NDAs/BLAs/MAAs. The Associate Director partners with the Head of Regulatory ... Director partners with the Head of Regulatory Operations in developing processes and standards… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...and tracking of labeling milestones. Collaborates with Global Labeling Operations and Compliance Leads to produce high quality labeling… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders.Summary The Associate Director , Global Clinical Operations (GCO) Procedural Ownership ... policies, and meet applicable ICH and GCP standards. The Associate Director will also be responsible for...experience in one or more key functions (eg clinical operations , clinical research, clinical science, and/or CQA). Strong experience… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders.Summary The Associate Director , RACMC, is responsible for the regulatory CMC (Chemistry, Manufacturing ... on Component teams and/or serve as G-RACMC lead or regional submission lead. Provide regulatory guidance and strategy to CMC sub-team and G-RA teams along with other… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …collaborating closely with Translational Science Leads, Clinical Biomarker Leads, Biosample Operations , Clinical Leads and Regulatory Liaisons to ensure ... successful implementation of CDx and data collectionSupports Regulatory affairs in providing content and providing review of...of the GPT CDx representative while keeping abreast of regulatory and policy updates in the external environment and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …with key roles in Global DX / GDO / GCO / BDM / RD Finance/ CSPV/ Regulatory Operations / QA to ensure optimal definition and adoption of metrics. Act as a ... with one or more clinical systems like CTMS, EDC, eTMF, Planisware, Product Registry, Regulatory etc. required4 or More Years Experience in working with CRO data for… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- Associate Director , Clinical Operations Sun Pharma Advanced Research Company Limited Princeton, New Jersey SummaryThe Associate Director , Clinical ... process, and contract review. Act as primary point of contact from clinical operations for assigned trials.Oversee study start up activities of CROs (eg Site… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to seek alignment and share resources across multiple groups. Relationships Reports to Associate Director or above within CMR Training & Knowledge Management. ... 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… more
- SYSCO (Warminster, PA)
- …and other individualized factors$10,000 Sign-on BonusJOB SUMMARYThis is an Operations position responsible for directing the activities associated with the ... and effectively.Develop business relationships to ensure communication and efficient operations with third-party vendors, including but not limited to, janitorial,… more
- Merck (North Wales, PA)
- …Looking for someone with a growth mindset. **Position Description:** The Senior Director , Global Regulatory Lead, is responsible for development and ... **Job Description** Our Regulatory Affairs team bring new medical advancements to...but are not limited to:** + Reports to Executive Director or Associate Vice President, General Medicine… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , Clinical Operations Pleasanton, CA, USA * Princeton, NJ, USA Req #367 Friday, June 28, 2024 Looking for a chance to make a meaningful ... multiple complex global studies to support the Clinical Development Plan. The Associate Director (AD) is responsible for ensuring assigned clinical studies… more
- Novo Nordisk (Princeton, NJ)
- …clinical development and regulatory requirements of a clinical program. The Associate Director will provide high level strategic input into development ... with cross-functional project teams, including Medical & Science, Clinical Operations , Biometrics, and Regulatory Affairs personnel, to...plans, study designs, and regulatory submissions. Relationships The Associate Director… more
- Merck (West Point, PA)
- …and are grouped into center-led categories and regional operating teams. ** Associate Director , Supplier Development & Performance Management (SD&PM) Responsible ... global team of Supplier Development & Performance Management (SD&PM) Field Specialists/ Associate Director responsible for developing and managing supplier… more
- Amicus Therapeutics (Princeton, NJ)
- … Operations , Regulatory and other internal partners, the EQL Associate Director is actively engaged in ensuring outsourced manufacturing is performed ... Associate Director , External Quality Lead (Small...Amicus's External Manufacturing activities, working in partnership with Technical Operations and Regulatory Affairs to ensure compliance… more
- J&J Family of Companies (Titusville, NJ)
- Associate Director , Field Access & Affordability Solutions-Southeast- Immunology-Derm (Horsham, PA/Titusville, NJ) - 2406196197W **Description** ** Associate ... and Customer Solutions (PECS) team is recruiting for a home office-based, Associate Director , Field Access & Affordability Solutions Immunology position within… more
- Merck (Trenton, NJ)
- …component of decision-making at our company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas. This ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an...Associate Director will work with scientists within… more
- J&J Family of Companies (Horsham, PA)
- Associate Medical Director , Rheumatology Therapeutic Area - Medical Affairs - 2406188235W **Description** Johnson & Johnson is recruiting for an Associate ... more at https://www.jnj.com/. As a member of Immunology (IMM) Medical Affairs, the Associate Medical Director , Rheumatology TA will assist in strategic planning… more
- Ascendis Pharma (Princeton, NJ)
- …grow and develop their skills. Position Description We are looking for an experienced Associate Director / Director of Specialty Pharmacy & Trade, who will be ... key targeted Specialty Pharmacy & Trade Accounts and affiliated stakeholders. The AD/ Director will, in close collaboration with key internal stakeholders from across… more
- Taiho Oncology (Princeton, NJ)
- Associate Director , PV Sciences Pleasanton, CA, USA * Princeton, NJ, USA Req #361 Friday, June 28, 2024 Looking for a chance to make a meaningful difference in ... on a transformative journey with Taiho Oncology as an Associate Director in PV Sciences. At the...Business partners). + Effectively manage to ensure compliance with regulatory submissions and internal timelines. + Participate in audit… more
