- Daiichi Sankyo, Inc. (Bernards, NJ)
- …2009) o FDA Guidance for Industry and Investigators - Safety-Reporting Requirements for INDs and BA/BE Studies (December 2012) o Japan Ministry of Health, ... areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas...o 21 CFR § 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs -… more
- Lundbeck (Philadelphia, PA)
- …and transform lives. Join us on our journey of growth! As a Neuroscience Account Manager , this is an incredible opportunity to join the growing promotion of our CNS ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… more
- Lundbeck (MA)
- …transform lives. Join us on our journey of growth!As a Psychiatry Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.REQUIRED… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …that these systems are compliant with global regulatory and Daiichi Sankyo requirements , and business expectations. Executes the Global DX Computer System Validation ... Contribute to the Daiichi Sankyo validation strategy by considering regulatory requirements , industry best practices and company policies and procedures. Provide… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to FDA .RelationshipsThe fellow will report to the fellowship track manager within the Regulatory Affairs - Therapeutic Area team throughout the one-year ... investigational or marketing application in accordance with applicable SOPs and FDA regulations/guidances.Maintain up-to-date knowledge of data requirements and… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary: Exela Pharma Sciences is seeking an experienced and dynamic Senior Manager , IS Quality to build and lead our IS Quality function. The ideal ... candidate will be responsible for ensuring compliance with regulatory requirements , industry best practices and internal standards as well as managing quality… more
- Insmed Incorporated (San Diego, CA)
- …GMP stability studies across all phases of drug development.Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA ) as they relate to drug ... join the Quality Control leadership team. As the QC Stability and Sample Management Manager , you will be responsible for the daily oversight for the QC stability and… more
- Merck & Co. (Lenexa, KS)
- …response to product inquiries and adverse reports in accordance with internal, FDA , CFIA and USDA regulatory policies.The successful candidate for this position will ... work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …documents where necessary with supervision.Health Authority Interactions: Leads US FDA /EU EMA interactions with support from higher-level manager .Regulatory ... the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support,...the meeting minutes. This position develops awareness of global requirements through support of global submissions and this position… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …in the treatment of multiple myeloma.Legend Biotech is seeking QA Manufacturing Excellence Manager as part of the Quality team based in Raritan, NJ. Role OverviewThe ... QA Manufacturing Excellence Manager role is an exempt level position with responsibilities...therapy manufacturing plant to support both clinical and commercial requirements in a sterile GMP environment. This role will… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical communications; responses ... health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …when required, , moves and changes. For example: Training center and divisible room requirements for FDA and training department - manage the reassignment of ... tasks and areas of support are determined by the Manager Facilities Services based on demand of each functional...or More Years in a corporate environment preferred Physical Requirements Able to lift and move boxes weighing up… more
- Novo Nordisk Inc. (Durham, NC)
- …production goals, while adhering to applicable cGMPs & SOPs. Relationships Shift Manager . Essential Functions Setup, operate, monitor & control equipment, systems & ... production data in BPR & associated forms Follow all safety & environmental requirements in the performance of duties Other accountabilities, as assigned Physical … more
- Aequor (Thousand Oaks, CA)
- …(LSC), and under the supervision of the Therapeutic Area Lead, the Labeling Manager is responsible for supporting the facilitation and management of the end-to-end ... & post marketed products over the product's life cycle. The Labeling Strategist, Manager will lead the development of the Core Labeling documents. and US Labeling… more
- Novo Nordisk Inc. (WA)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... approach, leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships with… more
- Merck & Co. (Rahway, NJ)
- …members of study teams, including external CROs/Vendors, to incorporate study team requirements into all deliverables. You will also be involved in developing ... and coordinating CDS technical initiatives. Supporting the clinical database manager /supervisor in project planning, manpower projections, and resource allocation… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Relocation assistance is available for selected candidate.RelationshipsReports to: Manager , Compliance & InvestigationsNumber of subordinates with direct/indirect ... impacted by outstanding deviationsEnsure investigations will comply with internal NN requirements and are compliant with cGMP regulationsUpdate SOPs or other… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …Releases product based on Quality Assurance record review and approval by QA Manager Performs regular internal audits of NNUSBPI facilities as a lead auditor Works ... Way and 10 Essentials in all activities and interactions with others Physical Requirements Local and International travel: 0-5%. The ability to stand, crouch, walk,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …or material handling tasks in a backup role, as needed. Updates supervisor/ manager of work status or problems with recommendations for improvement or correction. ... in a manner consistent with the safety policies, quality systems and cGMP requirements . Other duties will be assigned, as necessary. Key Relationships: Works in a… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …production of a personalized cell therapy to support both clinical and commercial requirements in a sterile cGMP environment. Job duties will be performed within a ... records and ensure safe and compliant manufacturing operations according to cGMP requirements .Lead the daily start of shift operations meetings, the daily wrap up… more
