- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... of country labeling deviations for assigned Daiichi Sankyo products ensuring compliance with all applicable Health Authority (HA) regulations and guidelines,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Title -Director/ Principal Scientist, Regulatory Compliance Department - Device Quality & Regulatory Brief Description of Position- This ... (GRACS). The primary responsibility for this position is to ensure regulatory compliance for the company's portfolio of medical devices and medical device… more
- Tris Pharma (Monmouth Junction, NJ)
- …Complaints (PQC) documentation, compliance efforts, quality operations, etc. Responsibilities:Assures compliance with all SOPs, cGMP, FDA , as well as all ... degree in science or related field and minimum 6 years quality and/or cGMP compliance experience in the pharmaceutical or biotechnology industry in positions of… more
- Merck & Co. (North Wales, PA)
- … advisory letters, enforcement letters and policy issues affecting the pharmaceutical /biologics industry. Communicate significant changes in FDA perspective to ... business objectives.Serve as the liaison and manages correspondence with FDA 's promotional review divisions Office of Promotion and Advertising… more
- Merck & Co. (Rahway, NJ)
- …involves strategic partnering with Development Quality, Process Research & Development, Pharmaceutical Operations, and other parts of the AR&D organization in ... aspects of quality control and compliance . Your main responsibilities will include: - Strategy and...hold one of:- PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …documents (eg, clinical overviews, formulary dossiers, online evidence repository). Ensure compliance with FDA requirements as they affect medical ... 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)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... to build a phase appropriate quality system that supports quality and compliance of Good Clinical Laboratory Practices and Good Laboratory Practices. Proactively… more
- Merck & Co. (Durham, NC)
- …operations also required. Must possess strong understanding of the current pharmaceutical industry and applicable regulations ( FDA /EU/ICH), with emphasis in ... facilities, utilities, manufacturing, packaging, labeling, and laboratories to ensure compliance with company policies, procedures, and regulatory expectations. Be… more
- Merck & Co. (North Wales, PA)
- …Immunology, or PAH (Pulmonary Arterial Hypertension) experience.-Strong understanding of the compliance landscape, including FDA , OIG, and CMS regulations ... their lifecycles, offer structuring for copay programs, ensuring government compliance , managing high-impact vendor relationships, leveraging consumer data analytics,… more
- Lundbeck (Boston, MA)
- …customers and patients including the full range of treatment options available. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of ... and regulatory environment, including Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical… more
- Eisai, Inc (Dallas, TX)
- …preferably in a biopharmaceutical manufacturer capacity)Strong understanding of pharmaceutical manufacturer compliance & regulatory requirementsDemonstrated ... relationships across multidisciplinary matrix team within Eisai.Advanced understanding of pharmaceutical manufacturer compliance & regulatory requirementsAbility to… more
- Tris Pharma (Monmouth Junction, NJ)
- …capabilities, when needed. The incumbent ensures timeline, quality and compliance with applicable Standard Operating Procedures (SOPs)/current Good Manufacturing ... packages per International Council for Harmonization (ICH)/Food and Drug Administration ( FDA ) guidance and provides technical guidance within and outside R&D for… more
- Merck & Co. (Rahway, NJ)
- …and accurate information and status updates to project sponsors and management.Champion compliance and safety; promote a culture of diversity, inclusion, and equity. ... leadership and project management, and regulatory knowledge in the Pharmaceutical /Biotech industry OR Master's degree in Chemical Engineering, Bioengineering,… more
- Eisai, Inc (Los Angeles, CA)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... of representatives selling efforts in accordance with strategic plans and compliance , monitoring and driving sales goals, and coaching Sales Representatives on… more
- Merck & Co. (Rahway, NJ)
- …as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.The ... qualify new CMOs/CROs/CDMOsQualifications: Education: Ph.D. in chemical engineering, chemistry, pharmaceutical sciences, pharmaceutics, biochemical / biomedical engineering, or relevant… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... Independently leads cross functional teams through all labeling discussions with the FDA /CHMP while ensuring management alignment. Strategizes and plans for FDA … more
- Lundbeck (San Diego, CA)
- …payer access issues (IDNs, Medicare, Medicaid, Commercial) using Lundbeck resources. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of ... environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical ... legal issues pertaining to assigned business areas. Work collaboratively with Compliance colleagues to develop and implement training to internal clients, partners… more
- Lundbeck (Detroit, MI)
- …landscape in addition to other payer channels including Medicaid and Commercial. Pharmaceutical Environment/ Compliance - Ability to apply knowledge of ... environment, including accountability and adherence to Lundbeck policies and procedures and FDA regulations regarding the promotion of pharmaceutical and medical… more
- Eisai, Inc (Providence, RI)
- …and caregivers is Eisai's human health care (hhc) mission. We're a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong ... speaker programs for meaningfulness, effectiveness, educational in nature, and compliance with company policies. Key responsibilities include:KOL Engagement Engage… more
