- Legend Biotech USA, Inc. (Raritan, NJ)
- …Compliance will be responsible for providing quality oversight over the compliance program within the global quality organization to ensure harmonization, ... and auditing teams for continuous improvement projects.Support the enhancement and Global harmonization of the supplier qualification program , including… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …CMC sections or regulatory submissions, risk assessments, validation impact assessments, global change controls, draft industry guidelines , specification & ... Legend Biotech is a global biotechnology company dedicated to treating, and one...process validation activities in support of the commercial Carvykti program both within Legend but also externally with our… more
- Insmed Incorporated (NJ)
- …affairs, drug development, FDA and regulatory guidelines (ie, PhRMA guidelines , OIG, AMA, ACCME, Sunshine Act, etc.) Global mindset with understanding ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...of people leadership experience E xpert knowledge of relevant guidelines including, but not limited to medical and regulatory… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... you'll have a critical role in hands-on execution and oversight of global regulatory submission activities across assigned programs and market. Under the guidance… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... Communications & Publications, you'll lead the development and implementation of global Medical Communications Strategy across regions. You will have high visibility… more
- Insmed Incorporated (NJ)
- …meetings, etc. Global Pharmacovigilance experience, including robust knowledge of global PV regulations and applicable ICH guidelines .Experience in preparing ... so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of...designed for the people behind it. You deserve a workplace that reflects the same care you bring to… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... both clinical and commercial supply chains.Your responsibilities will include supporting global CMC regulatory strategies that align with our clinical and commercial… more
- Genmab (NJ)
- …treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive ... thingOversee direct report compliance with the Genmab Code of Conduct, guidelines and all policiesResponsible for timely completion of administrative duties (ie:… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …building future capabilities. We're responsible for regulating accounting, upholding workplace safety, managing our supply chain and sampling, supporting ... have the opportunity to build a career in a global business environment. We encourage our employees to make...deal while fully compliant with all legal and regulatory guidelines (in collaboration with legal counsel). Develops solutions which… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... with an MD or DO preferred, along with 10 years of global experience in ophthalmology clinical development within the pharmaceutical/biotech industry. Additionally,… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …functions such as Pharmacology, CMC, Regulatory Affairs, Clinical, and Program Management.Maintain up-to-date knowledge of evolving regulatory guidelines ... Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... operations, enterprise risk management, and Computer Systems Validation (CSV) program . This role will manage cross-functional teams and ensure...Part 11, EU GMP Annex 11, and GAMP 5 guidelines a plus .Experience collaborating with Quality, IT, and… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... 11, Electronic Records and Electronic SignaturesExperience with GAMP 5 guidelines and validation lifecycle processesIT System Project managementExperience managing… more
- Genmab (NJ)
- …treatment and serious diseases. We strive to create, champion and maintain a global workplace where individuals' unique contributions are valued and drive ... Tabulation Model (SDTM) standards that support the scientific need of a study/ program while ensuring quality, consistency and compliance to CDISC standards and other… more
- Insmed Incorporated (San Diego, CA)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... and resolution guidance. Train, coach, and mentor GxP system owners. Provide CSV program trainings, lunch and learns and guidance to new stakeholders as well as… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... lab business processes is preferred.Solid working knowledge of CSV guidelines and FDA/EU regulations: 21 CFR Part 11, Annex...designed for the people behind it. You deserve a workplace that reflects the same care you bring to… more
- Insmed Incorporated (San Diego, CA)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... to the clinic.Strict adherence to environmental, health, and safety guidelines .Pay Range:$89,000.00-119,267.00 AnnualLife at InsmedAt Insmed, you'll find a culture… more
- Insmed Incorporated (NJ)
- …patient counts - and so does every person who joins in. As a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare ... preferred.Experience with Veeva QualityDocs /QMSSolid working knowledge of CSV guidelines and FDA/EU regulations: 21 CFR Part 11, Annex...designed for the people behind it. You deserve a workplace that reflects the same care you bring to… more
- Amazon (Seattle, WA)
- …within the Global Centers of Excellence and includes the disciplines of Global Design, Workplace Guidelines , Business Development, Global Integrated ... best practices, technology, and innovations are adopted into the program . About the team The Global Real...owns the creation, implementation, and ongoing refinement of Amazon's Global Workplace Design Guidelines and… more
- Cushman & Wakefield (O'Fallon, MO)
- **Job Title** Global Climate Risk & Workplace Safety Manager **Job Description Summary** POSITION SUMMARY The Global Climate Risk & Workplace Safety ... Manager oversees the delivery, coordination, and quality control of global climate risk and workplace safety audit programs. This role manages three regional… more
