- Terumo Medical Corporation (Somerset, NJ)
- …more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We ... / 13485 / 14971, 21 CFR 50/56/812, and ICH-GCP and applicable regulatory requirements, while driving continuous improvement in clinical quality systems and… more
- Merck & Co. (Rahway, NJ)
- …President, Clinical and Development Digital Solutions (CDDS IT), the Executive Director, Digital Regulatory and Safety, will lead our efforts in transforming ... AI.Primary Responsibilities: Develop and promote a multiyear product strategy for Digital Regulatory & Safety, aligning with IT and Research and Development (R&D)… more
- Merck & Co. (Rahway, NJ)
- …ONSITE 3 DAYS PER WEEK)The Submissions Content Source Management Business Operations Lead is expected to understand the end-to-end regulatory submission process. ... Policy Implementation, Regulatory Compliance, Regulatory Labeling, Regulatory Operations, Regulatory Submissions, Strategic Thinking {+… more
- Merck & Co. (Rahway, NJ)
- …experience in leading organizational transformation initiatives and driving strategic changeExperience with drug-device combination product development, ... to the Sr. Director of Device Product Assessment & Innovation (DPAI), the Director, Lead of Strategy for Device Product Assessment & Innovation will define and build… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAre you enthusiastic and driven to create and lead execution of design verification testing strategies for innovative combination products?Join our ... including inhalation, implantation, and injection.The Associate Principal Scientist will lead the definition and execution of design verification strategies, and… more
- Merck & Co. (Rahway, NJ)
- …risks across all factors that may impact technical, operational & regulatory success or timelines. -Analyzes and develops innovative solutions to unforeseen ... challenges, proactively prioritizing, interrogating and mitigating risks across technical, regulatory and operational factors.- Conducts options analysis and provides… more
- Merck & Co. (Rahway, NJ)
- …R5-equivalent - About the role We are hiring a Senior Product Manager to lead strategic development of our Integrated Printing and Plastic Manufacturing system - ... production execution, quality, and fulfillment. Your leadership will reduce waste, shorten lead times, lower TCO, and enable new commercial models for custom and… more
- Merck & Co. (Rahway, NJ)
- …Center of Excellence (COE) is responsible and accountable for technical leadership, strategic planning and portfolio execution of key work in support of Centers ... combination product technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape… more
- Merck & Co. (Rahway, NJ)
- …clinical research, the Clinical Director at this level will be expected to lead a Product Development Team (PDT) through late-phase clinical development and into ... post-licensure life-cycle management. This role demands scientific depth, strategic leadership, and the ability to operate at the highest level within a diverse,… more
- Merck & Co. (Rahway, NJ)
- …the field.As a Senior Principal Scientist, you will drive various strategic initiatives and translate strategies into- implementation for Biologics platform. You ... challenges across projects and functional teams, in a fast-paced, multidisciplinary environment. Lead the development of robust and scalable upstream processes for… more
- Merck & Co. (Rahway, NJ)
- …as well as for commercialization and in line commercial projects. Lead development and implementation of robust non-GMP characterization methods, using quality ... within the team. Inspire, encourage and support scientific excellence. Foster strategic thinking to anticipate and support key partner needs. Utilize effective… more
- Merck & Co. (Rahway, NJ)
- …will possess deep technical expertise, a strong track record in problem-solving, strategic acumen, and execution, along with exceptional leadership skills to shape ... the technical capabilities and strategic direction for a global, cross-modality technical team. The...for a global, cross-modality technical team. The Director will lead a team of technical experts responsible providing Logistics… more
- Merck & Co. (Rahway, NJ)
- …this role, the Director of the Raw Materials and Medical Devices will lead a team of approximately 10 specialists and scientists supporting excipients, package ... of inspection readiness at all times. The Director should be well engaged with regulatory and industry trends and have thorough working knowledge of GMPs, ICH, and… more
- Merck & Co. (Rahway, NJ)
- …growing HF teams in a regulated environment.Deep knowledge of global HF regulatory requirements, FDA guidance, and industry standards.Strong strategic thinking, ... Senior Director of Human Factors (HF) will provide visionary leadership and strategic direction for the HF function within our company. This role leads… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready ... with a less traditional background. **Job Description** The Group Lead , Supply Chain CoE - North America will ...practices and competitors. **5. Program Management Office (PMO) & Initiative Deployment** - Oversee PMO functions to ensure successful… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …tools to enhance commercial performance. **Responsibilities:** **Leadership and Collaboration** + Lead the company-wide initiative to identify, consolidate, and ... with IT, compliance, and external vendors to ensure data integrity, privacy, and regulatory adherence. + Immersion in strategic and tactical plans of the… more
- SMBC (New York, NY)
- …**Role Description** SMBC Special Credits Group is seeking an Executive Director to lead the Corporate Product Team. This is a key leadership role reporting to ... the Front Offices, leading a team of 8-10 professionals, and driving strategic initiatives within the group. **Role Objectives: Delivery** Role Responsibilities: The… more
- Sanofi Group (Morristown, NJ)
- **Job Title:** Strategic Initiative Lead - Regulatory Data, Digital and AI **Location** : Cambridge, MA or Morristown, NJ **About the Job** Do you thrive ... the intersection of regulatory expertise and digital innovation? As the Strategic Initiative Lead , you will turn bold ideas into validated opportunities,… more
- Sanofi Group (Morristown, NJ)
- … impact assessments for proposed product changes + May serve as a regional/local regulatory lead and point of contact with medical deviceHealth Authorities for ... for medical devices Due Diligence activities as applicable May serve as Device Global Regulatory Lead (dGRL) leading a Device GRT, which includes the additional… more
- Citigroup (New York, NY)
- …maintain a robust, adaptable governance framework tailored to the evolving needs of the Strategic Ledger Initiative . + ** Regulatory Support** : Ensure the ... are seeking a highly experienced and driven Senior Governance Lead to shape and oversee the governance framework for...shape and oversee the governance framework for our groundbreaking Strategic Ledger Initiative . This critical role will… more
