- Repligen (Waltham, MA)
- … public company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting ... processes including all global subsidiaries. Reporting directly to the VP Corporate Controller,...accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Global Senior Director of Medical Affairs (GDMA) for Melanoma coordinates the development of the Global Scientific and Medical Affairs ... Plans for their assigned asset(s). Sr . GDMA collaborate with global Commercial, Outcome...advances. The GDMA coordinates medical affairs activities to resolve regulatory , reputational, ethical, and other asset management issues and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including the timely deployment of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to ... diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi...trials or for approval of CDx. Keeps abreast of regulatory and policy updates in the external environment and… more
- Merck & Co. (Rahway, NJ)
- …placement, monitoring, analysis, regulatory reporting, and publication.- Specifically, the Senior Director may be responsible for: Providing scientific and ... mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with...and dedicated colleagues while developing and expanding your career.The Senior Clinical Director ( Sr . Principal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. SummaryThe Senior Director of Clinical Operations will manage clinical operations staff ... and ensure ongoing collaboration and communication with internal stakeholders. Detailing The Senior Director will ensure a robust communication plan including… more
- Merck & Co. (Upper Gwynedd, PA)
- …analysis, regulatory reporting, and publication. -- Responsibilities: Specifically, the Senior Director may be responsible for: -Analyzing and summarizing ... Job DescriptionOur company is a global health care leader with a diversified portfolio...radically changes the way we approach serious diseases. --The Senior Director will report to an Associate… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Job Summary: The Sr . Director , Clinical Safety MD, will lead the development and ... Global Product Team in collaboration with Clinical Development, Regulatory , Project Management, Biostatistics, Pharmacology, and other departments to… more
- Eisai, Inc (Nutley, NJ)
- …per week#LI-CCEisai Salary Transparency Language:The base salary range for the Senior Director , Clinical Quality Assurance is from :236,900-310,900Under current ... (QAP) position is responsible for design, delivery and execution of the global Clinical Quality Assurance (CQA) strategy including audit and inspection management,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …all Medical Affairs programs. This role involves deputizing for the Sr . Director , representing the Quality organization at senior levels. The Director ... studies, non-interventional studies, Compassionate Use or Managed Access Programs.Collaborate with the Sr Director , Medical Affairs QA to conduct quality reviews… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs ... VP of Regulatory Affairs, lead the development and implementation of global regulatory strategy plans to facilitate efficient and driven product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... so, he or she will align closely with the Global Project Team and Global Team Leader...plans, clinical protocols, and in the submission of certain regulatory documents, as well as supporting commercial in developing… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionJoin our Millsboro Senior Leadership team and lead a high-impact Integrated Process Team that directly influences site performance, product quality ... operations, formulation and fill/finish activities.Ensure compliance with corporate and regulatory requirements (cGMP/USDA) and lead IPT support for audits,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director (ED) for US Medical Affairs (USMA) understands Our Company's enterprise level strategies and leads cross-functionally with the ... Global Medical and Scientific Affairs Therapeutic Area (GMSA TA)...including tactical execution by the field Regional Medical Scientific Director (RMSD) teams and is accountable for ensuring field… more
- Genmab (NJ)
- …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 ... policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report...Regulatory Affairs (GRA) and will report to the Sr . Director , Labeling, Policy and Intelligence. The… more
- Merck & Co. (Rahway, NJ)
- …monitoring, analysis, regulatory reporting, and publication. Specifically, the Senior Director may be responsible for:Evaluating pre-clinical and ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and dedicated colleagues while developing and expanding your career. Senior Director ( Senior Principal Scientist)… more
- Merck & Co. (Rahway, NJ)
- …team and coordination efforts with colleagues across the local site and global our company network in shaping and implementing next generation technologies and ... to write SOPs and technical documents and present to peers and senior management.Analytical skills: Ability to analyze complex data and make recommendations for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- … Knowledge: Deep understanding of FDA, EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational Excellence: Expertise ... Legend Biotech is a global biotechnology company dedicated to treating, and one...production schedules.Will have 3-6 direct reports ranging from Associate Director , Senior Manager, and Manager.Oversee the hiring,… 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 ... MA training modules). The focus of these plans and activities will be either global , US-focused with intended use and adaptation by other regions globally, or solely… more
- Merck & Co. (Rahway, NJ)
- …leadership, technical skills, and scientific acumen as part of a global , cross functional team.Job ResponsibilitiesResponsible for leading specific aspects of ... clinical data/medical protocol deviations in collaborations with the Clinical Director .Other responsibilities include:Collaborating cross-functionally in the development of Protocol… more
- Cytek Biosciences, Inc. (San Diego, CA)
- SUMMARY: The Director / Sr . Director , Reagent Operations will lead and manage reagent manufacturing operations, worldwide distribution and positioning of ... market demand; transforming reagent operations to support min 50%+ increase in global segment annual revenues. ESSENTIAL DUTIES AND RESPONSIBILITIES : To perform… more
