- Merck & Co. (Upper Gwynedd, PA)
- …and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned ... regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team.Manage execution… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!Role:The Associate Director acts as a statistical expert supporting the clinical development of compounds as ... responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication LevelAct… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to address regulatory questions from Global Health Authorizes (HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners to ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMA Competencies: Advanced ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Merck & Co. (Rahway, NJ)
- …the preparation of materials for program presentations for management review and regulatory submission.Contribute to the development, implementation, ... Development Associate Principal Scientist - Development Strategy, Design Controls(Associate Director Equivalent) Our company's Device Development & Technology (DD&T)… more
- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... due diligence assessments and provide expert consultation on chemical manufacturing matters. Review process change requests and deviation reports while ensuring … more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be... Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… 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 ... organization. From healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (North Wales, PA)
- …role will focus on supporting HPV. Under the guidance of an Executive Director , within the Value and Implementation, Outcomes Research the incumbent has the ... of patient reported outcomes, epidemiological studies and economic modeling.The Director also works closely with Product Development Teams, Franchise Teams,… more
- Repligen (Waltham, MA)
- OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham, MA facility which has proven experience in the biotechnology ... including deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an ISO… more
- Tris Pharma (Monmouth Junction, NJ)
- …in our Monmouth Junction, NJ facility for an experienced, hands-on SR. Director / Director , Procurement. Title and salary commensurate with experience. The ... Director / Senior Director , Procurement is responsible for...assurance of compliance with GxP and other company and regulatory agency procurement policies and procedures throughout the organization.… more
- Merck & Co. (North Wales, PA)
- …trial objectives.Liaises with partners, vendors, and vendor management team . Review and provide clinical operations input into relevant clinical documents such ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… more
- Formation Bio (New York, NY)
- …with global regulatory expectations (eg, FDA, EMA, ICH); author and review regulatory submissions including INDs, BLAs, and other key documents. Continuous ... faster and more efficiently.About the PositionWe are seeking a Senior Director , Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is responsible...R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning and execution ... strategic plan for assigned therapeutic area(s). These deliverables include development and review of compliant scientific exchange materials to be used in external… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the planning and ... and MSL managers. Develop congress abstract tracker, assign MSL coverage, review MSL reporting responsibilities, collate and distribute Congress Report, execute pre-… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …customers. Relationships This position reports into a Vice President or Sr. Director within the National Account Market Access Teams. Internally, this position has ... pricing implications and downstream impact of the evolving public policy, government, regulatory landscape and other relevant trends Identifies and builds a broad… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance position is ... US, EU Directives, US FDA, PMDA, ICH). Essential Functions Independently conduct audits Review and oversee results of CQA audits of study sites, clinical vendors,… more
