- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders. Summary The Associate Director of Regulatory Writing is a key role responsible ... provide scientific and strategic insights at the study team level. The Associate Director of Regulatory Writing must possess advanced knowledge of BLA/MAA… more
- Merck & Co. (Lower Gwynedd, PA)
- …Us: The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late ... utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and… more
- Daiichi Sankyo, Inc. (Bernards, 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...EU and US Documentation: Independently manages, prepares and implements regulatory documents (eg, USPI, annotated labeling, medication guides, EU… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and partnering with FDA. This role will create and implement effective regulatory strategies to deliver on efficient and robust development plans. The individual ... will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support...of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines… more
- Genmab (Plainsboro, NJ)
- …our best, and authentic is essential to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager/ Associate Director will be ... portfolio of products. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr... Affairs (GRA) and will report to the Sr Director , Labeling, Policy and Intelligence. The position will be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the head of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...internal stakeholders. In the execution of specific projects, the Associate Director , will be accountable for managing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to maximize your potential with us? The Position The Associate Director will be the lead who is responsible for ensuring that ... Reports to the Sr. Director , Patient Support Solution Quality/Safety Associate Director . Interacts with colleagues within Patient Support Programs, Patient… more
- Genmab (NJ)
- …the development of the clinical development plan (CDP) Author components with Medical Director and reviewer of clinical and regulatory documents and registration ... aspects of clinical development) working closely with the Medical Director and other cross-functions to provide high-quality and timely deliverablesResponsibilities… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …development. Are you ready to maximize your potential with us? The Position The Associate Director , Data & Analytics Governance is responsible for the governance ... skills to ensure vision is maintained across various NNI functions. Relationships The Associate Director , Data & Analytics Governance reports to the Senior … more
- Merck & Co. (North Wales, PA)
- Job DescriptionTitle: Associate Director , Product Marketing Owner - Scientific Strategy and Payer Access Team Lead, Heart FailureGeneral Description: Our ... customers around the world. Join our organization as a results-driven and visionary Associate Director , Product Marketing Owner - Scientific Strategy and Payer… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Tax, Compliance and Legal team members to ensure compliance with all relevant regulatory , accounting, tax and internal requirements. This person leads the timely and ... accurate delivery of payroll services and is responsible for maintaining the payroll system and related technologies.ResponsibilitiesManages all payroll supporting processes and controls which include:Provides audit support for internal and external auditors.… more
- Merck & Co. (Rahway, NJ)
- …Research & Division organization of our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early Drug ... progress the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director . Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... (USDA, DEA, DNREC, etc.) of animal facilities and program reviews is required.PurposeThis Associate Director will report to the Site Quality Head/ Director … more
- Merck & Co. (North Wales, PA)
- …and systems for a pharmaceutical company, ensuring compliance with regulatory requirements and maintaining high-quality standards.- Product managers must possess ... teams to develop and implement pharmacovigilance strategies that meet regulatory requirements and ensure patient safety, quality and compliance.-Oversee PV… more
- Merck & Co. (Rahway, NJ)
- …of decision-making at our Company, this position offers an opportunity for the Associate Director to drive pipeline impact across therapy areas.This Associate ... on a continuous basis in decision making and driving pipeline impact. The Associate Director will perform job duties independently with minimal supervision… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference? The Position The Associate Director , Research Partnerships (RP) is responsible for developing and executing ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...alignment with the Evidence Generation Plan (EGP). Externally, the Associate Director RP will be the lead… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... protocol profiles, and sections of submission documents under guidance of higher level. Reviews and oversee completion of clinical trial protocols. Provides medical and/or scientific direction to Clinical Operations. Represents Clinical Development on Project… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …at each phase of the development are scientifically sound, can fulfill regulatory requirements and deliver the pre-specified product profile.CRO / Vendor Oversight: ... Review CRO/vendor proposal and budget. Establishes procedures through regular interaction, setting expectation on deliverables and timelines to guide CRO biostatistician and statistical programmers on complex studies. Ensures deliverables are accurate and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA submission experiences for oncology ... area preferred TravelAbility to travel up to 30% Global and domestic travel. International collaboration and communication (face to face, electronic and tele/video conferencing) across all global time zones required Daiichi Sankyo, Inc. is an equal… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaborators, as we embark on shaping our future. The Position The Associate Director , HCP Experience has overall strategic and operational responsibility ... brands. Relationships Reports to the Hemophilia Therapy Area Lead. Works closely with Associate Directors and Sr Brand Managers across the Rare Bleeding TA and with… more
