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They are accountable, with the Precision Medicine Technical Lead to support BMS product Development Teams (DT) to successfully shape and execute the various translational and diagnostic strategies, projects, and lifecycle plans.
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In this role, the CMC Regulatory Manager will serve as the primary interface between Global Regulatory Sciences (GRS) & Global Product Supply (GPS) The GRS-CMC senior manager will assess Manufacturing Change Controls for global impact & guide technical teams on practical aspects of global change management.
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Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules, biologics and cell therapy submissions. Experience with CMC regulatory documents (IND/CTAs, BLA/NDAs, MAAs, responses, variations and briefing documents) Knowledge of FDA, EMA and/or ICH guidelines and CMC regulations Experience in drug development processes and post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a solution-oriented approach to problem solving Ability to plan/prioritize work of group members and guide/develop others.
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Experience and solid knowledge of Pharmacovigilance specificallyProficiency in one or more of these additional areas is a plus: CMC/Mfg., Clinical development and trial execution, Regulatory, Real-World Data and Real-World Evidence, Cell and Gene Therapy, Medical Device, IVD/CDxExperienced in understanding and interpreting regulatory guidelines and documents.
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Technical Leadership: Provide technical leadership and mentorship to front-end development teams, guiding them in best practices, coding standards, and modern React. Minimum of 8-10 years of experience in front-end development, with at least 5 years of hands-on experience in React.
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Support the enhancement, development and expansion of QA processes, including regular assessments and reviews in various departments/domains, such as, Behavioral Health, Dental, Perinatal Health and Ryan White program.
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The Department of Professional Psychology and Family Therapy within the College of Human Development, Culture, and Media at Seton Hall University invites applications for a full-time Lecturer, with essential teaching assignments in the graduate Applied Behavior Analysis and School Psychology programs.
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Job DescriptionPOSITION SUMMARY:The MNR Manager upholds the quality of the Equinox experience through education, programming and trainer development. Skill development of the fitness assessments, Complimentary PT sessions, and results review conversations through coaching, clearance, and feedback.
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Participate in ongoing professional development opportunities to stay current with best practices in science education and pedagogical strategies. Proven experience teaching AP Biology and AP Environmental Science; experience in teaching electives such as Human Anatomy and Physiology, and Forensic Science is highly desirable.
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Digital Product Owner must possess a broad base of skills and knowledge spanning digital technology, search engine optimization, campaign integration, a/b testing, analytics, strategy and business planning, user experience design, engineering and agile/lean development practices.
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Activity Aide Benefits: Competitive Wages and Benefits Package Paid Time Off Opportunities for professional development and continuing education. NOW HIRING: Activity Aide Part-time- days during the week and every other weekend Activity Aide Qualifications: High school diploma LTC/SNF experience Serious applicants Complete Care at Cedar Grove (former Genesis) is an equal-opportunity employer.
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Qualifications: At minimum, a Bachelor’s degree in Chemistry, Biology or related science with a strong background in DMPK and BA including knowledge of the FDA GLPs. + years of Regulatory drug development experience Experience with CTD documents and nonclinical study reports for submission to global regulatory agencies.
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Join Chick-fil-A and be part of a dynamic team that offers great opportunities for growth and development. Chick-fil-A is hiring a highly skilled Back of House Team MemberAre you passionate about working in a fun and loving environment where teamwork and leadership are valued.
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As a certified PMP with a breadth of hands-on project management experience in the Pharma/Biotech/Cell Therapy regulated environments, the CTDO Sr. PM is expected to perform with minimal supervision and effectively facilitate the successful delivery of a wide process development and commercialization activities within the CTDO organization from initiation to completion while remaining aligned with company strategy, commitments and goals.
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At Atlantic Health System, Our Promise To Our Communities Is That Anyone Who Enters Anyone Of Our Facilities, Receive The Highest Quality Care Delivered At The Right Time, At The Right Place, And At The Right Cost. That Commitment Is Also Echoed In The Respect, Development And Opportunities We Give To Our More Than 18,000 Team Members.
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product development front jobs in Florham Park, NJ
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