- Merck & Co. (North Wales, PA)
- …the necessary processes to ensure high quality individual case and aggregate safety reporting. Interpret PV regulations related to drugs, vaccines, biologics, and ... and external stakeholders with processes that ensure compliance with local and global PV regulations.Ensure that PV activities are supported by robust procedures… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …or a life sciences/pharmacy nursing degree with 15+ years' experience in global safety surveillance and/or clinical/ drug development Excellent verbal ... the US East Coast Development Hub comprised of Senior Global Safety Leads, Global ...external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development… more
- Merck & Co. (Rahway, NJ)
- …drugsAnalyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionThe Clinical Director (Principal Scientist) has primary responsibility for planning and directing clinical research activities involving… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Team (SMT) materials- Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), ... research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Management Team (SMT) materialsSupports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), ... areas centered around rare diseases and immune disorders. Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …be the Clinical Science Group Lead in late phase development in the Global Clinical Science function. He/she will be responsible for managing the multiple Clinical ... Science Asset Leaders (CSALs) at the Senior Director level for each respective program. This Clinical Science...clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …as well as alliance partners, promoting a cohesive team approach.Regulatory and Safety Compliance: Understand study conduct from supply chain/ drug forecasting to ... for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (North Wales, PA)
- …drugs;-Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... an environment of mutual respect, encouragement and teamwork. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated… more
- Merck & Co. (Boston, MA)
- …leader to join the Boston Discovery Chemistry Leadership Team as a Director (M3). The successful candidate will be responsible for multidisciplinary portfolio ... support the sustained delivery of a multi-modality portfolio. In addition, the Director will participate in department- and network-wide activities such as resource… more
- Merck & Co. (Rahway, NJ)
- …commercial formulation development and GMP clinical supply manufacture of our company's drug product pipeline.- The FLEx Non-Sterile Production Lead will steer this ... Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have...based in New Jersey and reports to the Executive Director of FLEx Non-Sterile Operations in Pharmaceutical Operations &… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Merck & Co. (Rahway, NJ)
- …and inclusive work environment.Essential Knowledge, Duties & Responsibilities for the Director Include:Sterile drug product development concepts, tools, and ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...for the research and development of sterile & parenteral drug products for biologics including monoclonal antibodies (mAbs), di-… more
- Merck & Co. (Rahway, NJ)
- …experience Preferred Experience and Skills: Knowledge of Investigational drug regulatory requirementsAudit experience: safety , environmental, ... Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New… more
- Merck & Co. (North Wales, PA)
- …and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... of generating early clinical development plan and Investigational New Drug applicationsDeveloping clinical development strategies for investigational or marketed… more
- Merck & Co. (Rahway, NJ)
- …drugs.Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionOur company in the United States and Canada, is a global health care leader with a diversified portfolio of prescription medicines, vaccines, and… more
- Merck & Co. (Rahway, NJ)
- …drugs;Analyzing and summarizing the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications, clinical ... Job DescriptionOur company is a global health care leader with a diversified portfolio...and dedicated colleagues while developing and expanding your career.--The Director (Principal Scientist) has primary responsibility for the planning… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for cardiovascular diseases, under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily ... Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Proven track record in senior Leadership roles, such as Director or Senior Director of a drug development function such as Clinical Drug Development ... ensure M&S area is a strategic partner in the projects and clinical drug development activities. This includes actively driving innovation and taking a broader and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... the opportunity to build a life-changing career in a global business environment. We encourage our employees to make...Position This position will support company compliance to the Drug Supply Chain Security Act (DSCSA). This includes Line… more
- Fidelity TalentSource LLC (Merrimack, NH)
- Job Description:The Director in Global Product & Markets Information (GPMI) is part of the Fidelity Fund & Investment Operations group. Global Product & ... business partners and business. The Purpose of Your RoleThe Director will be joining the global team...weeks). At Fidelity, we value honesty, integrity, and the safety of our associates and customers within a heavily… more
