- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disorders.Summary This role is responsible for leading and mentoring a dynamic and global Regulatory Intelligence & Policy team, through direct and indirect line ... that DS is prepared to meet new or proposed global regulatory requirements and that DS has...should prioritize external engagement efforts for maximum impactDefines a global strategy for achieving policy-shaping objectives (eg… more
- Merck & Co. (North Wales, PA)
- …mitigation measures.Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.Lead ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist /...development and execution of detailed, global regulatory submissions of INDs, BLAs or… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary Responsible for leading and developing global regulatory strategy for assigned development projects. ... into a global strategy .Responsible for ensuring aligned global regulatory strategy is endorsed by GPT and other governance bodies.Serve as… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Global Regulatory Matrixed Team in defining and executing the global regulatory strategy for assigned programs to ensure timely and high-quality ... to make a difference?The Position We are seeking a collaborative and science-driven global regulatory expert who wants to work with innovative investigational… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …company's growth, thereby accomplishing corporate goals.Responsibilities:Develop and implement US regulatory strategy for assigned project(s). Strategize and ... preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure that regulatory… more
- Merck & Co. (North Wales, PA)
- …, Regulatory Affairs Liaison, is responsible for development and implementation of global regulatory strategy for their assigned projects in the Vaccines ... the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy /registration requirements for one or more of our… more
- Merck & Co. (Rahway, NJ)
- …leader engagement execution, target product profile development, health authority interactions, global regulatory filing strategy , organized customer ... Job DescriptionWe are currently recruiting for a Director of Global Oncology Marketing to...input on such activities as:target product profile (TPP) development, global regulatory filing strategy , launch… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Director , Global Oncology Marketing (Brand) is responsible for maximizing the ... Global Brand Lead. Responsible for actively contributing to the development of the global brand strategy and for leading the development and execution of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …up to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA ... Training and Documentation management team. This position will take direction from global strategy and operational QA leader, however is also accountable to the… more
- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively- participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports to the Director /Senior Director in the Office of...review divisions of FDA (OPDP/APLB) or experience developing/leading the regulatory strategy for a product filing/launchUnderstanding of… more
- Merck & Co. (Rahway, NJ)
- …providing commercial input on such activities as: target product profile development, global regulatory filing strategy , labeling, launch readiness reviews, ... for the oncology portfolio.- The Global Marketing Director will lead overall strategy development for...chain: basic science and biology, clinical development and innovation, regulatory processes, global launch dynamics, access and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Oncology Communications The role of Director , Global Communications, Oncology is a unique ... role will work under the guidance of the Executive Director , Global Oncology Communications in a fast-paced...audiences in alignment with the company's corporate narrative and Global Oncology business strategy while continuously partnering… more
- Merck & Co. (Rahway, NJ)
- …LATAM and APAC. Leads site EHS leaders and influences site, region and global business partners to drive prioritization of regulatory compliance, continuous ... Job DescriptionOur Animal Health Division is a trusted global leader in veterinary medicine, dedicated to preserving and improving health, well-being, and… more
- Merck & Co. (Rahway, NJ)
- …stakeholders, to lead / co-lead activities as belowTarget product profile development, global regulatory filing strategy , launch readiness reviews, organized ... Job DescriptionWe are recruiting for a Director Global Oncology Marketing for a...will include but not be limited to the following:Brand strategy development and executionL3 Next development and execution including… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SummaryLeadership responsibility for global regulatory strategy to support the development of ... procedures. Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and… more
- Merck & Co. (Rahway, NJ)
- …for a range of modalities including small molecules and peptides.- Within OFS, the Director will influence the strategy , lead activities, and develop a team ... Job DescriptionOur company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring consistency and harmonization of the implementation of the CMR training strategy Ensuring CMR employees receive training on regulatory compliance, ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...and harmonization of the implementation of the CMR training strategy . Serve as the CMR Training representative; Liaise with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the implementation of the quality strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology ... open and effective communication and business partnering the cross-functional implementation of the Strategy , and Vision and Mission of Global RD/PV QA. Drive a… more
- Insmed Incorporated (Bridgewater, NJ)
- …regarding the potential impact of toxicology results on Program and Clinical/ Regulatory strategy .Author nonclinical sections in regulatory submission ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...certification preferred.Minimum of 15 years of experience as a regulatory toxicologist (study director /monitor and/or project lead)… 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 health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
