- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight. This role fulfills the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Internal Process Audits is responsible for end-to-end GxP relevant audit ... effectively. Ensure the internal systems auditing program fulfills regulatory requirements performs audits, identifies compliance issues and trends, reviews systems… more
- Lundbeck (Fresno, CA)
- …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 ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight. This role fulfills the… more
- Lundbeck (Fort Wayne, IN)
- …the way in creating positive customer experiences! As a BioPharmaceuticals Account Manager , you lead the promotion of our infusion product, driving demand creation ... and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Lundbeck (Waco, TX)
- …to stakeholders in the primary care and neurology settings. As an Account Manager , you lead the promotion of our psychiatry portfolio, executing sales and marketing ... including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical products.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy ... and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) oversight and deviations management.… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Manager Audits & Compliance, GCP/Document Audits supports end-to-end audit activities ... or more years proficiency in ICH GCP Guidelines, US and European regulatory requirements for the conduct of clinical trials and creation of regulatory submission… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disordersJob Summary: The Regulatory Process Manager will be a key member of the Global Regulatory Affairs (GRA) ... in quality management in the pharmaceutical industry and quality (GxP) requirements Experience with process mapping, process redesign and SOP authoring/coordination… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …create an engaged workforce.GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global regulatory requirements for pharmaceutical ... personalized cell therapy to support both clinical and commercial requirements in either a Grade C or sterile cGMP...have 3-6 direct reports ranging from Associate Director, Senior Manager , and Manager .Oversee the hiring, development, and… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …and processes are verified and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross functional teams to ... candidate will be commensurate with experience. Relationships Reports to: Manager , Process Support (Downstream) Essential Functions Assist with coordinating… more
- Genmab (NJ)
- …from/to business partners in collaboration with the programmer and the data manager , as applicableEnsures state of the art statistical work which includes but ... in biologics, targeted therapies, and companion diagnostics preferredExperience working with FDA , EMA, and ICH guidance for drug development pertaining to… more
- Eisai, Inc (Nutley, NJ)
- …speakers and related aspects of speaker programsCollaborate with Promotional Program Manager for speaker usage and issuesOffer feedback on nominating new speakers ... etc.Remain on the cutting edge of data readouts (consistent with FDA -approved labeling), medical congress meeting outputs and podium & symposia… more
- Eisai, Inc (Nutley, NJ)
- …Associate Director must be a highly specialized individual contributor or functional manager with advanced knowledge and expertise to analyze assess and initiate ... area need in terms of program development and propose/implement solutions. Requirements Bachelor's degree in computer science or related field required.Must have… more
- Cytiva (Pensacola, FL)
- …Engineering preferred.Regulatory and Quality Expertise: Strong knowledge of ISO standards, FDA regulations, cGMPs, CFR requirements , and quality management ... about the Danaher Business System, which makes everything possible.As the Senior Manager , Site Quality you will collaborate closely with cross functional leadership… more
- Leica Biosystems (Miami, FL)
- …Use Only (RUO) product development and sustainment.This position reports to the Senior Manager , Regulatory Affairs and is part of the Global Regulatory Affairs Team ... the opportunity to:Develop and execute global regulatory strategies, including FDA 510(k), Pre-Submissions, Health Canada filings, and Technical File… more
- Cepheid (Miami, FL)
- …identify and implement improvements. This position will work with the Senior Manager Quality Systems Compliance.This position is part of the Quality department and ... manner with effective corrective action. Participate in external audit management (eg FDA , ISO, Danaher Corporate, foreign governments), in either a supporting or… more
- Cepheid (Miami, FL)
- …Regulatory Compliance, and operations systems and processes to include GMP and QSR requirements for medical devices. (ISO 13485, FDA 's QSRs, EU's MDD, Canadian ... therapies, clinical impacts to patients and latest Post Market Surveillance requirements . You will have growth opportunities within Post Market Quality, and… more
- Beckman Coulter Diagnostics (Miami, FL)
- …skills in automation, integration, and Generative AI.This position reports to the Senior Manager Innovation DBSL and AI and is part of the Quality, Regulatory and ... developer and business integrator, translating business challenges into technical requirements and actively participating in the full solution development… more
