- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides ... The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory ...preparing agenda and tracking action itemsResponsible for maintaining global health authority query (HAQ) tracker and archiving regulatory… more
- Merck & Co. (Rahway, NJ)
- … regulatory , quality, company, and customer requirements.-This position will lead cross-functional development teams within and external to Device Development. ... product programs under your leadership.Remain current in relevant worldwide regulatory guidance and standards. Lead /support/oversee clinical supplies production… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to ensure timely and high-quality regulatory deliverables to the GPTs Lead health authority interactions, including leading team through creation of briefing ... new medicines for patients. We recognize that improving human health starts here and that patients rely on us....wants to work with innovative investigational medicines. You will lead a global regulatory team to develop… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … agencies. Supervise designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs. ... the most diverse and collaborative groups within the organization. From health -care-provider interactions and developing and implementing regulatory strategies… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience ... regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to experiment with us? The Position The Diagnostics and Precision Health Lead will be responsible for developing and implementing a diagnostics and ... and developed within the organization. Essential Functions Diagnostics and Precision Health Strategy Development: Lead the development of diagnostics and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disclosure for collection, retention, testing and retesting of samples Project Team Participation: Provide device-specific regulatory insight/guidance during ... to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs)...device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key… more
- Eisai, Inc (Nutley, NJ)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... play a pivotal role in ensuring the organization's adherence to security, regulatory , and compliance standards. Collaborating with business and EIT stakeholders, you… more
- Merck & Co. (Millsboro, DE)
- …Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal Health Manufacturing IT (GAHM IT) ... Quality and Business support at the Millsboro site. The Site Digital Technology Lead ensures all project and commercial manufacturing activities are supported… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …understanding of Pharma or life sciences manufacturing processes, cGMP practices, regulatory health authority CMC requirementsExperience with federal subsidy ... Position Summary The Director of Project Management will lead a team of project management professionals ensure projects are executed effectively and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... function at meetings with health authorities; Oversees management and performance of CRO. Occasional...leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs;… more
- Merck & Co. (Durham, NC)
- …transfer of the HPV vaccine manufacturing process while ensuring compliance with all regulatory and safety guidelines. Lead a diverse team and be accountable ... project management experience Risk Management experience Experience supporting regulatory inspections- Change Execution Management / Strategy Realization Framework… more
- Merck & Co. (Durham, NC)
- …Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health ) While Optimizing Our Base Business) Adapt - Develop Our People, Culture ... to advance projects goals and deliverables related to the vaccine process Lead technical studies and author documentation associated with equipment, cleaning, and… more
- Merck & Co. (North Wales, PA)
- …responsible for developing medical writing deliverables that support the clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer: ... Demonstrates independence in preparing clinical regulatory documents (eg, protocols, clinical study reports, investigator's brochures, clinical sections of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical ... function at meetings with health authorities; Oversees management and performance of CRO. Occasional...leadership as needed; Participates in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs;… more
- Insmed Incorporated (Bridgewater, NJ)
- …10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the pharmaceutical or biotechnology industry or within a ... 10 years of experience as a regulatory toxicologist (study director/monitor and/or project lead ) in the pharmaceutical or biotechnology industry or within a … more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThis role is primarily accountable for the end-to-end performance and project management for assigned protocols in a country in compliance with ... and link between Country Operations and clinical trial team (CTT).Responsible for project management of the assigned studies: pro-actively plans, drives and tracks… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the project duration- May participate in meeting or teleconferences with health authorities Operational Excellence Innovation - May lead and/ or participate ... The position holder will require strong skills in continuous improvement, project management, change management and risk management.Responsibilities Project … more
- Eisai, Inc (Nutley, NJ)
- …healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking ... SMEs to understand how the functions operate today and what challenges are faced. Lead the analysis of the current state of business processes and systems. Establish… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and people with disabilitiesSummaryThis position will be the Clinical Science Group Lead in late phase development in the Global Clinical Science functionHe/she will ... Senior Director level for each respective programThis Clinical Science (CS) Group Lead will be responsible for overseeing multiple program-level CS Asset Leads who… more
