- Merck & Co. (Rahway, NJ)
- … Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... projects and teams as assigned.Key Accountabilities:Directs activities of the General Medicine global regulatory therapeutic area and team leading to global… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Strategy : Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal ... device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key...Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate… more
- Eisai, Inc (Nutley, NJ)
- …of staff. Determining timelines and budgets for program activities and report accordingly. Lead and participate in global regulatory initiatives and ... Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under...cycle management of existing products. May serve as the lead regulatory representative on the project team… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and best practices for GxP systems while ensuring alignment with the Global Digital Transformation (DX) strategy, regulatory compliance framework, and overall ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Upper Gwynedd, PA)
- …of the probability of regulatory success together with risk mitigation measures.- Lead development and execution of global product and project regulatory ... strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability… more
- Formation Bio (New York, NY)
- …biologic products, ensuring alignment with company goals and global regulatory standards. Team Development Build and lead a high-performing CMC ... manufacturing processes, formulation development, analytical methods, and global regulatory requirements. Proven ability to lead cross-functional teams and… more
- Rhythm Pharmaceuticals (Boston, MA)
- … Global Regulatory Affairs. Responsibilities and Duties Act as the Global Regulatory Lead on multi-disciplinary project teams and provide strategic ... strategies for the program(s) under your accountability. You will lead the regulatory strategy and initiatives for...execution of regulatory filings, maintaining compliance with global regulatory standards and commitments. You will… more
- Eisai, Inc (Nutley, NJ)
- …reports, education, and needs.Essential Functions Advance Medical and Scientific Knowledge of the Global Medical Team (45%) Lead Global MSL continuing ... statistics, etc.) to supplement MSL development.Collaborate with Digital Strategy & Innovation lead on global MSL insights sharing forums. Collate, prepare, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Responsibilities- GLOBAL CHANNEL STRATEGY CREATION (LINKEDIN PRIORITY)- Lead the development ... and engagement.- Oversee social media agency supporting LinkedIn globalization efforts- Lead internal review process/submission for establishing global channel… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... pediatric vaccines in the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of development therefore requiring… more
- Eisai, Inc (Nutley, NJ)
- …is your profile, we want to hear from you. The Vice President/Head of Global Clinical Operations is a senior leadership role responsible for overseeing all aspects ... ensures studies are conducted efficiently, within budget, and in compliance with regulatory standards. The Head of Clinical Operations leads teams of study managers… more
- Twist BioScience (South San Francisco, CA)
- Twist Bioscience is seeking a visionary and results-oriented leader to lead our global marketing efforts and drive sustainable growth. The Sr Director, Marketing ... is responsible for leading all aspects of Twist's global marketing activities. This person will plan, develop and...interfacing with customers. The Sr Director, Marketing also will lead growth marketing, social media and trade show efforts,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs the Product Security Lead Designer, you will play a pivotal role in shaping the security landscape of our organization. Your primary ... responsibilities will include:Designing Security Controls: Lead the design and implementation of innovative and robust security controls across various domains… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Market Access and Public Affairs (MAPA), Field Sales, Commercial Excellence, Regulatory Affairs, Integrated Customer Engagement, Global and other relevant ... organization, Clinical development, Research & Early Development, other affiliates, and the Global HQ teams. We are looking for highly motivated individuals who are… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …organization, Clinical development, Research & Early Development, other affiliates, and the Global HQ teams. We are looking for highly motivated individuals who are ... the lives of more patients than ever before. The Position The Thought Leader Liaison Lead plays a pivotal role leading a team of Thought Leader Liaisons who will… more
- Katalyst HealthCares and Life Sciences (Chula Vista, CA)
- …including change notifications, and lead EU related regulatory activities. Lead global regulatory assessments for product and manufacturing process ... changes via the document control process. Prepare and submit global regulatory product updates, as required. Serve as the voice of regulatory on… 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 ... will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the necessary… more
- Genmab (NJ)
- …feel like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible ... lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be...policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report… more
- Aequor (Thousand Oaks, CA)
- …Let's change the world. In this pivotal role, you will report to the Planning Lead within the Global Supply Chain Organization and will be accountable to deliver ... allocation discussions to enable revenue growth and supply for price sensitive markets. Lead and support special initiatives within the Global Supply Chain such… more
- Merck & Co. (Rahway, NJ)
- …focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and technical staff to support global and ... alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project Management:Provide… more
