- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy, Design Controls and Risk Management Our company's ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists.- The successful candidate will ... Job DescriptionOur company is a global health care leader with a diversified portfolio...technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory… more
- Merck & Co. (Rahway, NJ)
- …of Biologics and Biopharmaceutics, have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Daiichi Sankyo, Inc. (Bernards, 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 ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Merck & Co. (Rahway, NJ)
- …Based Sciences and will be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position is ... bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Represent MSAT at joint technical and CMC committeesPartner closely with senior leadership to achieve global alignment on all technical Carvykti ... and external CMO sitesDrive new process version plans and content for regulatory submissionsEnsure global records are consistent and maintained to achieve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... 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
- Daiichi Sankyo, Inc. (Bernards, 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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director, Alliance Management.Tris Pharma has a long track record of successful ... alliances, from global commercial partnerships to R&D collaborations to manufacturing/distribution partnerships....departments across all stages of the product lifecycle. The Associate Director, Alliance Management will be accountable for managing… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …one of the most innovative business units within Fidelity Investments. Our global , diverse team of hundreds of forward-thinking professionals lead with agility and ... our team reshape the future of finance. As a senior level engineer you will be an integral part...offsite with maximizing time together in person to meet associate and business needs. Currently, most hybrid roles require… more
- J&J Family of Companies (Skillman, NJ)
- Senior Associate , Regulatory Affairs -...love. Science is our passion; care is our talent. Our global team is made up of ~ 22,000 diverse and ... 2407025090W **Description** Kenvue is currently recruiting for: Senior Associate , Regulatory Affairs, Dietary...and Education Act_ .) and related guidance. Knowledge of global requirements related to Dietary Supplements is a strong… more
- JPMorgan Chase (New York, NY)
- …managing emerging risks and promoting responsible business growth. As a Compliance - Executive Regulatory Briefings - Senior Associate in our Regulatory ... LOBs/Functions including Control Management. Candidate will develop expertise on the firm's regulatory agenda as well as a deep understanding of how regulatory… more
- Publicis Groupe (New York, NY)
- …the stability and experience of a global leader. **Job Description** The Senior Associate , Regulatory Promotional Operations is a project-level lead ... for promotional materials to be reviewed through the client Medical, Legal, Regulatory (MLR) process. This role requires maintaining a strong working knowledge of… more
- Publicis Groupe (New York, NY)
- …the stability and experience of a global leader. **Job Description** The Senior Associate , Regulatory Promotional Operations must follow the protocol ... by our pharmaceutical company clients when submitting marketing materials for regulatory review. This includes preparing completed editorial content to the… more
- Publicis Groupe (New York, NY)
- …| Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Senior Associate , Regulatory Review must follow ... Description** Digitas Health is the Agency of Now: the first global connected-health agency, purpose-built for marketing today. Digitas Health specializes in… more
- Catalent Pharma Solutions (Somerset, NJ)
- …Friday,** **8:00AM - 5:00PM** Catalent Pharma Solutions in Somerset, NJ is hiring a Senior Regulatory and Compliance Specialist for the Compliance Group. The ... Senior Regulatory and Compliance Specialist candidate must...of Supplier and Customer Quality Agreements + Participate in global supplier and regulatory meetings and effectively… more
- Publicis Groupe (New York, NY)
- …stability and experience of a global leader. **Job Description** The Senior Manager, Regulatory Promotional Operations, is a subject matter expert ... materials to be reviewed through the client Medical, Legal, Regulatory (MLR) process. Acting as a lead for a...pertinent information. + Manage multiple direct reports at the Associate , Senior Associate , and Manager… more
