- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary The Director , Head of Global Dossier Planning, Regulatory Operations is responsible for leading the dossier ... Director of Dossier Planning will ensure high quality regulatory submissions to health authorities including but not limited... of Dossier Planning will report to Head of Global Regulatory Operations and be an active… more
- Merck & Co. (North Wales, PA)
- …Document for projects of increasing complexity.Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change ... Job DescriptionUnder general supervision of an Executive Director /Senior Director , the Principal Scientist / Director is responsible for developing and… more
- 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...and databases and support/coordinate the team to interpret this information into actionable insights, as they relate to DS's… 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 and ... with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our… 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...all US promotional materials and serving as the promotional regulatory expert with marketing, legal, and medical teams to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and implement the preparation of US regulatory submissions and provide US regulatory support across all global projects; meet aggressive deadlines to ensure ... all disciplines within the Daiichi Sankyo organization to obtain and/or provide information /data for regulatory filings.May serve as the single regulatory… more
- Merck & Co. (Rahway, NJ)
- …engagement execution, target product profile development, health authority interactions, global regulatory filing strategy, organized customer interactions, and ... 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 readiness reviews,… 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 ... recognize and respond to changing internal and external trends, market conditions, regulatory legislation, etc., evaluate and integrate the information to define… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Director , Global Oncology Communications The role of Director , Global Communications, Oncology is a unique ... for this role will work under the guidance of the Executive Director , Global Oncology Communications in a fast-paced and ever-changing… more
- Merck & Co. (Rahway, NJ)
- …commercial input on such activities as: target product profile development, global regulatory filing strategy, labeling, launch readiness reviews, organized ... Job DescriptionWe are currently recruiting for a Director , Global Marketing for Women's Cancer...chain: basic science and biology, clinical development and innovation, regulatory processes, global launch dynamics, access and… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionWe are recruiting for a Director Global Oncology Marketing for a new asset in the anti-LAG3 class of drugs. This new brand will be launched in the ... to lead / co-lead activities as belowTarget product profile development, global regulatory filing strategy, launch readiness reviews, organized customer… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... strategy closely aligned with the business strategy within one or more Global Project Team(s) (GPT) within Oncology Development Franchises or Business Units. Provide… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …to date- Support regulatory inspection related activities as required- Support Head, Global strategy and operations to develop and plan the Global QA ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionOur company is a global healthcare leader with a diversified portfolio of prescription medicines, vaccines, and animal health products. Our Research ... momentum, and an inspiring mission to achieve new milestones in global healthcare. Our company's Pharmaceutical Sciences & Clinical Supplies organization translates… more
- Eisai, Inc (NJ)
- …and governance meetings and lead processes improvement initiatives as required.Report to Director on issues and global strategies.Manage, mentor and develop ... is your profile, we want to hear from you. Job Summary The Associate Director , Clinical Outsourcing, will oversee and lead and support activities related to the… more
- Merck & Co. (Millsboro, DE)
- …and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections (USDA, DEA, ... Job DescriptionAssociate Director , Animal ServicesAbout the JobAnimal Health in Millsboro...rabbits, and rodents.Assure compliance with all federal and state regulatory requirements for animal welfare, management of controlled substances,… more
- Tris Pharma (Monmouth Junction, NJ)
- …success.We have an immediate opening in our Monmouth Junction, NJ facility for a Director , Drug Safety. The Director , Drug Safety is responsible for planning, ... The incumbent works cross-functionally with counterparts/teams in Clinical Development, Regulatory Affairs, Manufacturing, Quality, etc. to identify, evaluate and… more
- Insmed Incorporated (Bridgewater, NJ)
- … submissions [NDA/MAA safety sections and reference safety information /CCDS, PSUR/PBRER, DSUR], original articles, abstracts), and presentation materials.Drives ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...or contributing to preparation of clinical safety assessments and regulatory reports/ submissions involving safety information .Experience in… 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
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Associate Director , RACMC Portfolio Products, will be responsible for regulatory CMC (Chemistry, Manufacturing, and Controls) activities of the portfolio small ... responsible for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data,… more
