- 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
- BioAgilytix (Durham, NC)
- …related discipline Not less than two (2)years' experience in pharmaceutical /GxP/regulated environment Direct hands-on experience with computer systems validation ... qualifications Direct hands-on experience with local/international GxP regulations and industry guidance( FDA , EPA, EU, ICH, USP, ASTM and ISO) Skills: Ability to… 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 ... regulatory process optimizations on relevant topics.Responsibilities- Supports CMC regulatory compliance activities for portfolio biologics to meet US, International… 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
- 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 ... area including functional representatives, corporate representative, IT, privacy, legal, compliance , IT security, etc.Responsibilities- In conjunction with the Director… more
- Merck & Co. (Rahway, NJ)
- …This research opportunity is fast paced and contributes to the Pharmaceutical Sciences and Clinical Supplies (PSCS) deliverable which is the development ... and Research and Development division- - in particular Discovery Pharmaceutical Sciences, Biologics Analytical Research and Development (BAR&D), Bioprocess research… 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
- Novo Nordisk Inc. (West Lebanon, IN)
- …option 12 weeks Paid Parental Leave Free access to Novo Nordisk-marketed pharmaceutical products At Novo Nordisk, you will find opportunities, resources and ... Deviation Response Team team and a champion for quality priority principles and compliance within the organization.This role is a full-time onsite based role at our… more
- Lundbeck (Cincinnati, OH)
- …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
- Lundbeck (Stamford, CT)
- …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
- 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 ... validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider Outsourcing).… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …implementation and validation of IT systems using best quality practices in compliance with FDA regulations, including cloud technologies and IT ... IS Quality function. The ideal candidate will be responsible for ensuring compliance with regulatory requirements, industry best practices and internal standards as… more
- Eisai, Inc (Charlotte, NC)
- …marketing, managed markets, sales/business analytics, etc.)Strong understanding of pharmaceutical manufacturer compliance & regulatory requirementsDemonstrated ... 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… 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 ... school experience required- 4 or More Years experience in regulatory, compliance , and legal matters relating to investigational products, product promotion,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA , GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure ... compliance with testing SOPs and specifications.Participate in proactive functions...lab equipment, and quality and regulatory requirements important to pharmaceutical and combination drug manufacturing labs.Help with plant audit… 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 ... relevant Standard Operating Procedures (SOPs), Food and Drug Administration ( FDA ) regulations, EU Directives, and International Conference on Harmonization (ICH)… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Operating Procedures, Work Instructions, Deviations, and other quality documents for cGMP compliance and consistency with FDA regulations. Aiding members of the ... the efficient execution of critical quality tasks. Fostering efficiency, maintaining compliance with cGMP and other relevant regulatory requirements, and fostering… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ... responsible for quality and maintaining the highest standards in compliance within company policies, procedures, and all applicable regulations.Key Responsibilities… more
