- Merck & Co. (Rahway, NJ)
- …Sustainable Access Solutions (SAS) teams within GMAx to inform access strategy development .Provide access assumptions into business development assessments ... pricing and reimbursement strategy for our ophthalmology products. In this role, the Director will lead the development and execution of global market access… more
- Eisai, Inc (Nutley, NJ)
- …If this is your profile, we want to hear from you. The Executive Director , Global Clinical Development resides within the Oncology at Eisai. This Executive ... and oversight of the associated studies being conducted globally. The Executive Director will champion transformational business changes that deliver sustainable… more
- Genmab (NJ)
- …Associate Director will primarily be responsible for leading the development and maintenance of global labeling documents (eg, Core Data Sheet, USPI, ... employees.Our people are compassionate, candid, and purposeful, and our business is innovative and rooted in science. We believe... EU SmPC and related patient information) for the Genmab… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …provide input and updates within internal cross-functional teams (eg, Diagnostic Development Teams) and to external diagnostic business partners specifically:Use ... immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance… more
- Merck & Co. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division (Associate Director ).-This role serves as a Virtual Plant Manager - responsible for ... all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong … more
- Eisai, Inc (Nutley, NJ)
- …to ensure effective achievement of regulatory/ business objectives. The Executive Director will direct the development and submission of investigational drug ... and oncology, with a strong emphasis on research and development . Our history includes the development of...want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Implementation Services Lead plays a key role in overseeing the development , validation, implementation, and integration of GxP-regulated systems across the ... Leads and Technical Leads to ensure validation and technical implementation align with business priorities, GxP regulations (eg, Part 11), laws (eg, GDPR), and DS… more
- LanceSoft (Cambridge, MA)
- …of prior data and relevant comparisons. Perform program/project management and business development . Education, Behavioral Competencies and Skills: Graduate ... Job Title: Director , Signal Management Location: Cambridge, MA 02139 -...highest standards by working cross functionally and leading the development of required processes (eg, with Global Regulatory Affairs,… more
- Scholar Rock (Cambridge, MA)
- …and follow @ScholarRock and on LinkedIn. Summary of Position: The Sr. Medical Director , Drug Safety & Pharmacovigilance is a key position within the company and ... safety department, with significant impact on the development and life cycle of drug development ...pre- and post-approval for assigned products, the Sr. Medical Director will drive the proactive implementation of risk management… more
- Eisai, Inc. (Nutley, NJ)
- …to ensure effective achievement of regulatory/ business objectives. The Executive Director will direct the development and submission of investigational drug ... and oncology, with a strong emphasis on research and development . Our history includes the development of...want to hear from you. Job Summary The Executive Director , Regulatory Affairs will provide leadership and direction for… more
- Axon (Scottsdale, AZ)
- …matters at a company where you matter. Your Impact As ITAR Compliance Director , you will oversee Axon's International Traffic in Arms Regulation (ITAR) program. ... Do Location: DC, Boston, or Scottsdale offices with expected M-F standard business hours Reports to: Assistant General Counsel, Dedrone Direct project management of… more
- Azurity Pharmaceuticals - US (Woburn, MA)
- …collaboration with the Franchise Portfolio Management (FPM) and Commercial teams. The Medical Director Strategist will lead the development of the global medical ... rigor and creativity. As part of the Medical Affairs team, the Medical Director Strategist is responsible for providing medical input throughout the product life… more
- GenScript/ProBio (Piscataway, NJ)
- …as a Life Science CRO, enzyme and synthetic biology products, biologics development and manufacturing, and cell therapy. GenScript is committed to striving towards ... therapy, vaccine, biologics discovery and antibody protein drug to accelerate drug development for customers. ProBio's total cell and gene therapy solution covers… more
- Kyowa Kirin North America (Princeton, NJ)
- …adequate treatments currently exist, working from drug discovery to product development and commercialization. In North America, we are headquartered in Princeton, ... California, North Carolina, and Mississauga, Ontario. Summary: The Associate Director , Regulatory Affairs, Advertising and Promotion Compliance will independently… more
- Medtronic (Boston, MA)
- …Life of a Post-Market Risk, Quality Engineering Manager - reporting to Director of Post-Market Risk, Surgical Operating Unit. Responsibilities may include the ... and endorsing Production Post-Production Risk Assessments (PPPRAs) for Change Development Projects (CDPs) *Consults on New Product Development...and expertise in FDA 21 CFR 820 & 806, EU MDR (Regulation ( EU ) 2017/745), ISO 14971,… more
- SQA Services (Los Angeles, CA)
- …and CAPA. Create and maintain Quality and Technical Agreements in alignment with EU /FDA and global regulatory standards. Provide structured business planning to ... part of the Field Engineering team who manages the technical design, development and deployment of Life Sciences clients consulting, audit, remediation, and… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …of pharmaceutical development , medical affairs and GCP/GVP regulations including FDA, EU , MHRA, PMDA and ICH. Experience must include successful development ... assess the needs for functional processes and system enhancements Lead the development of internal functional processes and training and ensure alignment with global… more
- LanceSoft (Bothell, WA)
- …- $101/hr on W2 Job Details: The Clinical Development Scientist reports to the Director of Clinical Affairs in the business . To succeed in this role, you ... Title: Clinical Research/ Development Hybrid role Duration: 12+months contract Work location:...and dissemination, including Good Clinical Practice (GCP), FDA requirements, EU MDR (ISO14155, CFR Part 812, Med Dev 2.7.1… more
- WuXi AppTec (DE)
- **Overview** This position is responsible for leading the business development activities within STA, WuXi's CMC small molecule development and manufacturing ... This position manages sites for key accounts and is also responsible for business development for any new accounts. This position works proactively with other BU… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for the ... development and implementation of labeling content and strategy of...or creation of a new TLP, CCDS, USPI and EU SmPC. **How you will contribute:** **Management of Labeling… more
