- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , 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
- Merck & Co. (North Wales, PA)
- …of clinical data/medical protocol-deviations in collaboration with the Clinical Director .Builds talent and capabilities of direct/indirect team members ... the clinical trial team.Collaborates with the Medical Writer on clinical /scientific and regulatory documents.Partners with Study Manager on study… more
- Merck & Co. (North Wales, PA)
- …/Senior Director in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval of all US ... promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to...promotional messages and claims (aligned with marketing strategy) in clinical trial design and product labeling as it relates… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …trial (small size, standard complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with ... documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... ready to make a difference? The Position The Assoc Director OED - Supplies, is responsible for US and...those most recent years working as an employee in clinical , medical and/or regulatory in the pharmaceutical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... diverse external providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose… 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...3rd party development. This position partners with GRLs and Clinical Safety Pharmacovigilance (CSPV) leads in the maintenance of… more
- Merck & Co. (North Wales, PA)
- …Management Office (PMO), and Administrative Professionals.- Position Description/Summary: The GPAM Associate Director , Project Manager, is a core member of ... efforts to progress the R&D pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …gaps at the manufacturing sites.- Conduct scouting activities and recommend CDMOs for clinical and launch site selection from Tech Mgmt. (mAb, Drug Substance, Drug ... Support the compilation and technical review of relevant CMC sections of regulatory submissions (INDs/IMPDs, NDAs, BLAs, etc.), responses to regulatory … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …have solid understanding of the pharmaceutical marketplace including legal, medical, regulatory and clinical processes Develops accurate short- and long-term ... independently in order to accomplish objectives. Relationships Reports to the Director , Patient Support Programs Rare Disease. Key internal relationships include… more
- Merck & Co. (North Wales, PA)
- …professional development, and performance management Core Skills Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Proven ability ... the strategy and leads the operational planning and execution of one or more clinical trials. In this position, you will have the opportunity to demonstrate your… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as other research areas centered around rare diseases and immune disorders.SummaryThe Senior Director of Clinical Operations will manage clinical operations ... program. This position will require line management responsibility of Directors, Associate Directors, Clinical Study Managers, who are primarily responsibility… more
- Merck & Co. (Rahway, NJ)
- …the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology (QP2-IO) team in the role of Associate Director QP2-IO team is part of the Global Clinical ... of drug development and effective communication skills. As a subject matter expert, the Associate Director within the QP2-IO Group will work closely with teams… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical , Medical Affairs, HEOR and other stakeholders to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …vendor programming implementation, and expedite the preparation of regulatory submissions. Responsibilities include: make strategic programming decision and ... ensure its quality and integrity.- Provide hands-on statistical programming support to regulatory submission and help submission team in quick turnaround in response… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical , Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... Executive Director for collaboration with Document Management team and Regulatory Affairs to ensure proper maintenance, retention and archiving of all Patient… more
- Merck & Co. (North Wales, PA)
- … clinical development, including: study design, placement, monitoring, analysis, regulatory reporting, and publication.-Specifically, the Director may be ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; andAssist the Senior Director , Executive … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disciplines and cultures. Additionally, this position possesses advanced knowledge of clinical operations and processes and relevant regulatory requirements. ... vendors to ensure compliance with the protocol, external/internal standards, Good Clinical Practices (GCPs), applicable regulatory guidelines, Policies, SOPs,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, and clinical study report (CSR): Leads statistical activities for complex studies ... at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.- CRO / Vendor… more
- Merck & Co. (Rahway, NJ)
- …new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates molecules to medicines, working from the ... a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy, lead activities, and develop a team whose roles… more
