- Millipore Corporation (Billerica, MA)
- Global Regulatory Affairs , Oncology is actively involved in the development and life-cycle management of medicinal products thereby contributing to ... In this role you will support the preparation and execution of global regulatory strategies and to manage the submission and approval of applications for clinical… more
- Millipore Corporation (Billerica, MA)
- In the Global Regulatory Affairs , Oncology group you will be actively involved in the development and life-cycle management of medicinal products thereby ... agency interactions (FDA)Experience in IND / CTA / eCTD requirementsKnowledge of regulatory affairs applicable to location of residence (US and EU)Experience… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …molecule structure-guided R&D center in Berkeley, CA.Job Summary:This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... during 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno- oncology and small molecules in Japan, and Plexxikon Inc., our small… more
- Jazz Pharma (Philadelphia, PA)
- …development and with cross-functional team members including in clinical operations, regulatory affairs , drug safety and pharmacovigilance, and quality to ... expertise. Our therapeutic areas of focus include sleep and hematology/ oncology - areas in which we have a deep...and get to know Jazz Pharmaceuticals. Responsibilities: The Associate Director , Clinical Development, will join a growing team in… more
- Michael Page (Waltham, MA)
- …from minorities, women, the disabled, protected veterans and all other qualified applicants.SummaryThe Director of Regulatory Affairs will be accountable for ... delivery of regulatory affairs for the product portfolio, both strategy and operations....clinical aspects of regulatory preparation, delivering a regulatory strategy for novel therapeutics in oncology … more
- Millipore Corporation (Rockland, MA)
- …and marketing communications and activitiesWorks collaboratively with colleagues in the Regulatory Affairs , Medical, Legal, and Commercial team members during ... Your Role:The Director , Global Regulatory US Advertising and...related scientific disciplineA minimum of 8 years experience in Regulatory Affairs (3 in promotion and/or labeling… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …heart and kidney diseases, and other rare diseases. Job Summary:The Director /Associate Director , Global Medical Affairs Oncology (GMA), Rare Disease will ... MD degree in a relevant scientific field Minimum of 5 years of Medical Affairs experience, preferably as an Associate Director ; 8 years of professional medical… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …collaboration across functions, stakeholders and vendors. As required, the Associate Director provides operational input into regional Medical Affairs studies. ... measures set forth by the Study team. The Assoc. Director will be expected to work in a collaborative,...company, or Contract Research Organization (CRO). Experience in Medical Affairs and oncology desired; EAP experience highly… more
- Merck (Boston, MA)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... the way we approach serious diseases. The Director reports to an Executive Director in the Oncology Clinical Research Group. Under the guidance of a… more
- Aerotek (Florham Park, NJ)
- …products through approval in US and EUIn this position, the Regulatory Affairs Scientist-Strategy (Sr Manager to Director ) will lead execute strategy and ... Strategy, Fda, Regulatory , Nda, Regulatory submission, Cmc, Compliance, Oncology , PharmaceuticalTop Skills Details: regulatory affairs , regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Reviews regulatory documents from cross functional, ... 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno- oncology and small molecules in Japan, and Plexxikon Inc., our small… more
- Merck (Kenilworth, NJ)
- Job Description Under the guidance of an Executive Director , CORE Oncology , the incumbent has the primary responsibilities for developing the integrated evidence ... strategies to ensure that product value is defined and developed. The Director also works closely with Product Development Teams, Franchise Teams, Regional Product… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …in creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Reviews regulatory documents from cross functional, ... 2018 to 2025. Our powerful research engines include two laboratories for biologic/immuno- oncology and small molecules in Japan, and Plexxikon Inc., our small… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …heart and kidney diseases, and other rare diseases. Job Summary:The Director /Associate Director , Global Medical Affairs Oncology (GMA), Rare Disease will ... or MD degree in a relevant scientific fieldMinimum of 5 years of Medical Affairs experience, preferably as an Associate Director ; 8 years of professional medical… more
- Covance (Durham, NC)
- …simultaneously - Working collaboratively with Country and Regional Operations; Pharmacovigilance, Regulatory , Global Medical Affairs and Global Human Health ... Overview:Clinical Research Manager - Oncology Home-Based in the USA Why settle for...activities and has ownership, oversight and impact on local regulatory and financial compliance, at a country operations level… more
- The Clover Group (Cambridge, MA)
- …Apply. Global Medical Affairs Medical Director The Global Medical Affairs Medical Director to support immuno- oncology product activities related to ... of responsibilities include: Reviewing and approving medical and scientific content of Regulatory , Safety, Scientific Affairs , Medical Affairs , and… more
- Agilent (Carpinteria, CA)
- …to work with the Director of this group to ensure all Regulatory Affairs and Quality Design Assurance systems are established, implemented, and maintained ... global registrations in Companion Diagnostics in the field of Oncology . In this role you will have opportunity to...to closely work with the group of approximately 20 Regulatory Affairs and Quality Design Assurance professionals,… more
- Genentech (Pleasanton, CA)
- The Position Director Medical Affairs , Pharma Services: Medical and Scientific Affairs , Roche Sequencing Solutions Who we are At Roche, 91,700 people across ... in San Jose, CA and/or Pleasanton, CA, USA. Essential Functions of your Director Medical Affairs , Pharma Services role include the following: Represent Medical… more
- Millipore Corporation (Billerica, MA)
- …a functional budget of over $5 million. Reporting to the Head of Global Regulatory Affairs , you will work closely with key internal stakeholders including ... devices and innovative technologies in therapeutic areas such as Oncology , Neurology and Fertility. Our teams work together across...related scientific discipline You gained 15+ years' experience in Regulatory Affairs (8+ in US Ad/Promo and… more
- Genentech (San Francisco, CA)
- The Position Title: Principal/Senior Medical Director - Oncology PHC Function: US Medical Affairs Location: SSF "Before posting, we considered the business, ... and fill only those roles that are absolutely critical" Purpose The Principal/Senior Medical Director for Oncology PHC at Genentech puts patients and science at… more
