- Olympus Corporation of the Americas (Westborough, MA)
- …Global Head of Clinical Research and collaborates closely with the leadership of Clinical Affairs to lead clinical strategy activities and oversee ... @Olympus.com, it is likely not legitimate. **Job Description** The Global Lead of GI/ET reports directly to...strategic and operating planning activities in partnership with the Global Head of Clinical Affairs ,… more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. The Head of Global Regulatory Affairs Labeling is a key leadership role in the ... medical, and regulatory data and information. + Actively participates on the PDT Global Regulatory Affairs Leadership Team, providing input on key strategic,… more
- Takeda Pharmaceuticals (Boston, MA)
- …in medical affairs and Neuroscience.** **Experience successfully leading global cross-functional teams.** **Demonstrated ability to create, lead , and ... **Leads and expands Neuroscience Therapeutic Area (TA) including hiring of Global Medical Affairs (GMA) professionals covering different therapeutic indications… more
- Takeda Pharmaceuticals (Boston, MA)
- …**Job Description** Takeda Development Center Americas, Inc. is seeking a Manager, Global Regulatory Affairs , Marketed Products in Cambridge, MA with the ... Health Canada, and other international health authorities - Support regulatory team and Global Regulatory Lead (GRL) in preparations and timely delivery of… more
- AbbVie (Boston, MA)
- …data, guidelines and value proposition). Responsibilities: + In collaboration with Global Medical teams, Clinical Development, Commercial, Market Access, HEOR ... endpoint selection aligned with TPP. Works cross functionally to lead the development of the asset Phase 3b/4 strategy.... business strategy. + Proven ability to run a clinical study or medical affairs cross-functional team… more
- AbbVie (Boston, MA)
- …Engagement Plan generation in line with TA plan. Lead the individual ( Global ) Conference planning and execution. + Generates clinical and scientific data per ... (promotional material generation and product launches) and market access. Collaborates with clinical development on Medical Affairs support of priority trials.… more
- Merck (Boston, MA)
- … to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external ... **Job Description** Our Regulatory Affairs team bring new medical advancements to the...with a growth mindset. **Position Description:** The Senior Director, Global Regulatory Lead , is responsible for development… more
- Philips (Cambridge, MA)
- …outline proposal for balancing the project risk to project teams and Regulatory Affairs Management. + Lead communication and negotiation efforts with regulatory ... The Principal Regulatory Affairs Specialist will play a critical role in...market changes within Philips' Ultrasound business. **Your role:** + Lead business critical new product development projects, provide regulatory… more
- Edwards Lifesciences (Boston, MA)
- …negotiating deliverable timelines, and resolving project-related issues with cross-functional partners (eg, Clinical Affairs , Quality, R&D, etc.) + Act as a ... to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex international regulatory… more
- Pfizer (Cambridge, MA)
- The Global Clinical Lead is accountable for late-stage clinical development strategy, oversight and execution. The successful candidate will support ... & Operations to meet clinical development program deliverables. In this role you will lead the Global Clinical Team towards the common goal of approvable… more
- Pfizer (Cambridge, MA)
- …+ Represents TA Clinical Affairs and may take the lead on company-wide, global process improvement initiatives, and champions process enhancements and ... either as Pfizer-sponsored or as ResearchCollaborations.The CS is a global position and may support all types of Evidence...of complex solutions, and/or escalates as appropriate working with Clinical Affairs Lead , Clinical… more
- Sanofi Group (Cambridge, MA)
- …of what you thought was possible. Ready to get started? **Main responsibilities:** + As Global Regulatory Affairs Lead (GRL), you will be the fully ... **Job title: Global Regulatory Lead ** + Location: Bridgewater,...R&D, including at least 10 years of relevant Regulatory Affairs experience (regionally and/or global ), in early… more
- Takeda Pharmaceuticals (Boston, MA)
- …to bring life-changing therapies to patients worldwide. Join Takeda as Associate Director, Global Labeling Lead where you will be responsible for the development ... issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk...functions represented at the Labeling cross functional teams including clinical , safety, medical affairs , and commercial, to… more
- Olympus Corporation of the Americas (Westborough, MA)
- …for this role include: 1.) Infection Prevention disease state, procedural, clinical , and technological market knowledge & experience, 2.) Comprehensive mastery of ... clinical infection prevention & control proficiencies (eg, infection surveillance...a highly matrixed environment to architect Olympus' infection prevention global strategy encompassing all therapeutic areas and IP activities… more
- Pfizer (Cambridge, MA)
- …minimum of two in neurology. Biopharmaceutical experience as a medical monitor and clinical lead across therapeutic areas is desirable. Good understanding of ... **ROLE SUMMARY** The purpose of the Senior Director of Clinical Research role is to coordinate and lead...for Ph3 development. **ROLE RESPONSIBILITIES** The Senior Director of Clinical Research will develop a disease specific global… more
- Merck (Boston, MA)
- …* Collaborates internally with HQ functions, regional and local operations, EU Clinical Development, Pharmacovigilence, Global Medical Affairs to align ... goals, purpose and mission of our company's Research Labs, Global Clinical Development (GCD) and GCTO. *...Ability to identify problems, conflicts and opportunities early and lead , analyze and prepare mitigation plans and drive conflict… more
- Merck (Boston, MA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs , and global clinical trials operations) for ... between departments and therapeutic areas as part of a global team. **Primary responsibilities for the Principal Scientist include...the design and execution of early clinical development strategy + Taking a lead … more
- Sanofi Group (Cambridge, MA)
- …Location: Bridgewater, NJ or Swiftwater, PA or Cambridge, MA **About the job** The Global Regulatory Affairs Device team is a globally diverse team supporting ... portfolio of products. The team is part of the Global Regulatory Affairs , Regulatory CMC and Device...projects. You will work closely with key stakeholders including clinical , medical affairs , Industrial Affairs … more
- Sanofi Group (Cambridge, MA)
- …Ready to get started? The Clinical Research Director (CRD) is the primary clinical lead for programs and responsible for leading successful clinical ... to drive and deliver on multiple operational tasks. **Key responsibilities:** + Plans global clinical development strategy and generates the Clinical … more
- Merck (Boston, MA)
- …closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development projects; ... **Job Description** The **Senior Clinical Director (Sr. Principal Scientist)** has primary responsibility for the strategic planning and directing clinical … more