- Merck & Co. (CT)
- …leadership. - Key Functions Work Independently and as a Team member with Integrity - Precision - Accomplishment - Motivational Ambition - Respect - Inclusion ... Research & Development Division's leadership, including our Company's Investigator Study Program (ISP), by acting as the primary liaison to investigators interested… more
- Insmed Incorporated (NJ)
- …shared purpose-to transform the lives of patients through bold innovation, collaboration, and integrity in everything we do. We are seeking an experienced leader to ... operations, enterprise risk management, and Computer Systems Validation (CSV) program . This role will manage cross-functional teams and ensure compliance… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …universe for GMP relevant activities involving but not limited to supplier qualification program , CMC audit, clinical/IMP vendor audits and overall GMP vendor audit ... program . Establish lessons learned from audits/inspections to drive continuous...risks and provide good solutionCreate an atmosphere of trust, integrity and ethics. Qualifications: Successful candidates will be able… more
- Insmed Incorporated (NJ)
- …compliance with company policies and regulatory standards, and the quality and integrity of all reviewed materials. By driving process excellence, governance, and ... global-to-local handover of medical materials, ensuring consistency and scientific integrity in local adaptations.Develop, maintain, and enforce SOPs, work… more
- Butterball (Dudley, NC)
- …transfers, organizational changes, pay changes, etc.). . Helps maintain affirmative action program , reports, and logs to comply w/EEO/AAP & OSHA regulations. . ... Assists with data maintenance and integrity of data. Runs reports to review data for...and turkeys is everyone's responsibility and everyone's jobs. . Integrity : We trust each other to do the right… more
- Eisai, Inc (Dallas, TX)
- …and DME/MAC personnel.Essential Functions \tConsistently demonstrate uncompromised integrity while working cross-functionally and collaboratively with internal ... of legal and regulatory parameters related to patient access and support program services. Comply with all Eisai promotional and administrative policies and… more
- Insmed Incorporated (NJ)
- …technical expertise and business acumen to ensure regulatory compliance, system integrity , and alignment with business objectives across multiple IT platforms.What ... technical ownership, change control, and documentation while ensuring system integrity and regulatory adherence throughout the system lifecycleEnsure systems meet… more
- Insmed Incorporated (NJ)
- …escalation for all issues identified which may affect the quality and integrity of clinical studies.Perform medical monitoring, coding, and data cleaning, and ... SAE reports in collaboration with Clinical Operations.Ensure the medical integrity of clinical study reports and data interpretation/communication.Author or oversee… more
- Insmed Incorporated (NJ)
- …Part 11, Annex 11, GAMP 5, GMPs, Good Clinical Practices, Data Integrity .Strong technical writing skills for authoring, reviewing and approving validation plans, ... Computer Software Assurance (CSA) fundamental concepts.Basic understanding of data integrity (ALCOA+) principles.Strong customer service skills for internal and… more
- Genmab (NJ)
- …are determined to be the best at what we do; and we work with integrity -we do the right thingOversee direct report compliance with the Genmab Code of Conduct, ... Field Medical Affairs/CORE and synthesize medical insight to enhance program strategiesRequirementsAdvanced/scientific medical degree strongly preferred (PharmD, PhD, MPH,… more
