- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Microbial Process Operations (MPO) Team is seeking a Senior Principal Scientist with expertise in microbial process development for the production ... biomolecules, including novel biotherapeutics, vaccines, and engineered enzymes.As a senior scientific leader, the successful candidate will shape strategy, drive… more
- Merck & Co. (Rahway, NJ)
- …Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Proper Documentation , Regulatory Compliance, Regulatory Requirements {+ 4 ... MES, SCADA, DCS, and OEM systems-Work with process development teams on technical development and the testing of new technologies, trialing new automation… 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 healthcare provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Genmab (NJ)
- …a fit? Then we would love to have you join us!The RoleThe Senior Manager, Clinical Programming is responsible for the establishment, governance, and integrity of ... study or portfolio-level SDTM datasets are in compliance with CDISC and regulatory submission requirements, reviews study submission data packages to ensure quality… more
- Insmed Incorporated (NJ)
- …of regulatory submissions including INDs, NDAs/MAAs, and other required documentation . Ensuring compliance with ICH, FDA, EMA, PMDA and other international ... for patients with serious diseases. Reporting to the SVP, Technical Operations, you will lead all Chemistry, Manufacturing, and...activities for the company's small molecule pipeline. As a senior leader, you will oversee drug substance and drug… more
- Insmed Incorporated (NJ)
- …you?About the Role:The Director, EHS (Environmental, Health, and Safety) isa senior -level role responsible for creating and implementing programs that ensure ... workplace safety, regulatory compliance, and environmental protection for all Insmed locations.Key...audits and surveys, analyze results, and provide reports to senior management and other stakeholders.Advise senior leaders… more
- Insmed Incorporated (NJ)
- …role will manage cross-functional teams and ensure compliance with regulatory requirements while maintaining operational excellence. The Executive Director, ... building and protecting secure digital environments. The ideal candidate combines deep technical expertise with a proven ability to communicate complex risks in… more
- Merck & Co. (Rahway, NJ)
- …and documentation to meet program deadlines. - Authoring and reviewing internal technical reports, sections of regulatory filings ( eg, IND , BLA ) ... at its Rahway, New Jersey research facility. The Principal Scientist is a senior scientific role tasked with working closely with the group Director to define… more
- Oracle (Trenton, NJ)
- …AI-enabled population health platform. To support these efforts, we are hiring ** Regulatory Technical Documentation Engineers** with **deep engineering ... documentation + Experience preparing documentation for audits, technical files, or regulatory submissions. **Preferred** + Experience in healthcare,… more
- TD Bank (Mount Laurel, NJ)
- …developing and maintaining TD's US Recovery and Resolution Plans and other regulatory submissions, as required under the Dodd-Frank Act and other applicable ... regulations. This role will act as a industry liaison for regulatory policy, including engagement with trade associations; will be responsible for monitoring … more
- Otsuka America Pharmaceutical Inc. (Trenton, NJ)
- …post-approval supplements). Determine regulatory CMC content and scientific/ technical requirements to ensure documentation meets regulatory ... Global Regulatory Strategy). + Assess and provide regulatory strategy for CMC technical changes, process...Assess and provide regulatory strategy for CMC technical changes, process improvements, and new product introductions. Develop… more
- Oracle (Trenton, NJ)
- …leadership, presenting data-driven recommendations and guiding cross-functional alignment. + ** Technical Documentation :** Help lead the efforts across both ... and compliance activities** as HDI expands globally. Ensure operational processes and documentation align with regulatory standards and help drive readiness for… more
- Oracle (Trenton, NJ)
- …and ability to summarize complex trade-offs and options in presentation and technical documentation . + Ability to effectively represent engineering perspectives ... and working on ambitious new initiatives. A TPM at any level can have significant technical and business impact here. You will be part of a team of hard-working,… more
- Guardian Life (Holmdel, NJ)
- …efficient operation of our Group Underwriting organization. As the Group Underwriting Senior Technical Writer in Group Benefits Underwriting, you will ... and IT to gather source material and validate content. + Familiarity with regulatory standards and documentation practices in insurance. **You have:** +… more
- GRAIL (Trenton, NJ)
- …to project teams and leadership. They may manage and provide direction to regulatory staff and, when required, participate in senior management meetings as ... Test (LDT) products, including labeling, promotional materials, product changes, and documentation required for compliance and regulatory approval. + Monitor… more
- AbbVie (Florham Park, NJ)
- …LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Director, Regulatory Affairs Global Regulatory Strategy is responsible for developing ... in the obesity/metabolic therapeutic area (TA). This individual leads the Global Regulatory Product Team (GRPT and Labeling Regulatory Strategy Team (LRST).… more
- Oracle (Trenton, NJ)
- …of internal operations, controls, communications, risk assessments and maintenance of documentation as related to regulatory compliance and recommends ... and deficiencies. + Coordinates the preparation of and may prepare document packages for regulatory submissions from all areas of company as well as for internal and… more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … requirements. + Author FDA submissions (eg, 510(k), Q-Sub), EU technical documentation under MDR, and other global regulatory filings. + Evaluate medical ... **Job Description Summary** The Senior Regulatory Affairs (RA) Specialist will... regulatory submissions, including preparation and maintenance of technical documentation under EU MDR. + Demonstrated… more
- Sanofi Group (Morristown, NJ)
- …with regulatory bodies interaction + Develop the study level regulatory documentation (Abbreviated Protocol, Protocol, Amended protocol) for their project, ... **Job Title:** Senior Clinical Research Director **Location:** Cambridge, MA or...and investigators + Develop the clinical part of Briefing regulatory documents, Common Technical Document for submission… more
- Sanofi Group (Morristown, NJ)
- …with regulatory agency interactions + Develop or contribute to the regulatory documentation for the project(s), provide clinical leadership to other ... **Job Title:** Senior Clinical Research Director **Location:** Morristown, NJ Cambridge,...and investigators + Responsible for the clinical part of regulatory documents, Common Technical Document for submission… more
