- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as other research areas centered around rare diseases and immune disorders.Summary The Manager of Data Governance Stewardship will work in areas required for the ... o 21 CFR § 312.32: IND Safety Reports o FDA Guidance for Clinical Investigators, Sponsors, and IRBs -...IRBs - Improving Human Subject Protection (January 2009) o FDA Guidance for Industry and Investigators - Safety-Reporting Requirements… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH) ... guidelines. The Senior Clinical Study Manager will have routine interaction with key internal and...academic, community and industry organizations. The Senior Clinical Study Manager role is primarily a tactical study delivery role,… 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
- 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 ... 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)
- …related to pharmaceutical operations. required- 1 or More Years Direct dealings with FDA , EMA, PMRA, other regulatory agencies. preferred- 1 or More Years Strong ... appreciation of the impact of regulatory bodies on pharmaceutical operations. preferred- Experience auditing software vendors is preferred. preferred- International experience preferred; at minimum, experience working with diverse cultures and employees is… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …appropriate Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations/EU Directive, and International Conference on Harmonization (ICH) ... guidelines. Facilitate successful execution and adherence to timelines and clinical milestones of GOMA clinical activities as appropriate.Responsibilities Clinical Operations Study/ Program ManagementCompany Sponsored Studies (CSS) Support the preparation,… more
- Aequor (Thousand Oaks, CA)
- …experience in operations/manufacturing environment Direct experience with regulated environments ( FDA , OSHA, EPA, etc.) Working knowledge and experience with cGMP ... procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments and equipment Experience implementing risk-based verification on major GMP process equipment / automation projects, including… 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 ... solutions.Required Skills: Proven success leading cross-functional teams in an FDA regulated environment, excellent communication and interpersonal abilities, and… more
- Insmed Incorporated (San Diego, CA)
- …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 ... of drug development.Extensive knowledge of regulatory requirements and guidelines (ICH, CFR, FDA ) as they relate to drug substance and drug product stability… 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 ... be required to maintain contact with key industry professionals including veterinary and academic individuals and groups. Additional duties will include attending and often presenting research-based information at prominent industry/scientific meetings. The… 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 ... and this position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC matters. 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...years must include MSAT experience.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals. Experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support ... two-year program and will also have a reporting relationship with a manager /preceptor in the respective functional areas during their rotations. Additional key… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Facilities Management. Daily tasks and areas of support are determined by the Manager Facilities Services based on demand of each functional area, and the individual ... security by following procedures, monitoring logbook, and issuing visitor badgesWork with manager to ensure all procedures are followed to process visitors and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on desk registration system- Backup to leader of Facilities Services for FDA inspections- Manage Facilities home page on intranet, review content regularly, upload ... and responsibilities- Track and prioritize daily and weekly tasks, escalate issues to Manager - Run reports to monitor and track service tickets- Provide ad hoc… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Division of the Company. [Specific assignments to be determined by direct manager of the role.]- Creates, implements, and presents training programs and materials ... product promotion, scientific exchange, and disease state communications (including FDA regulations, False Claims Act, Anti-Kickback Statute, OIG guidance, the… 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 & ... demonstrated performance in the role/relevant area in lieu of work experience FDA regulated industry & solid dose manufacturing experience preferred Ability to read,… 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 ... products over the product's life cycle. The Labeling Strategist, Manager will lead the development of the Core Labeling...Knowledge of labeling within a Therapeutic Area Knowledge of FDA , or EMA, or other international regulations for 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
