- Merck & Co. (Boston, MA)
- … Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory Affairs and Clinical Safety (GRACS) function of Our Company's ... projects and teams as assigned.Key Accountabilities:Directs activities of the General Medicine global regulatory therapeutic area and team leading to global… more
- Amazon (Reading, MA)
- …Amazon Robotics (AR) Regulatory Compliance team ensures all AR products meet global safety and regulatory standards. As a shared service organization, we ... fulfilling and fun. Amazon Robotics is seeking a safety focused Regulatory Compliance Engineer with experience fielding industrial machinery with an emphasis… more
- Merck & Co. (Boston, MA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... pediatric vaccines in the Therapeutic Area. The incumbent will be expected to lead multiple programs that are in various stages of development therefore requiring… more
- Merck & Co. (Boston, MA)
- …(including discovery research, biostatistics, drug metabolism, modeling and simulation, regulatory affairs, and global clinical trials operations)Provide ... point in the drug development process, working closely with scientific, regulatory , statistical, and modelling colleagues across the organization to translate the… more
- Merck & Co. (Boston, MA)
- …other pharmacometric analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, ... PKPD Modeling, Population Pharmacokinetics, R-Studio, TeamworkPreferred Skills:Drug Discovery Process, Global Regulatory , Machine Learning, Multidisciplinary Collaboration, Multiple… more
- Amazon (Reading, MA)
- …systematic approach to identify, mitigate and manage risk to meet Amazon, regulatory and industry standards. This role will functionally partner internally with ... specifications for Manufacturing/Production System and Innovation labs based on Amazon, regulatory , and harmonized industry standards *Develop and drive safety and… more
- Azurity Pharmaceuticals - US (Woburn, MA)
- …market priming and products' share of voice (eg, scientific platform, key messages) Lead global Advisory Board meetings to inform and validate medical strategy ... Franchise Portfolio Management (FPM) and Commercial teams. The Medical Director Strategist will lead the development of the global medical strategy for assets… more
- Katalyst HealthCares and Life Sciences (Boston, MA)
- Job Description: This position reports to the Director, Global PV Quality Assurance and frequently interacts with cross-functional teams. This role is a member of ... the GVP QA team providing Quality oversight of global post-marketing pharmacovigilance system, including clinical safety, full application of EMA Good… more
- ZwitterCo (Woburn, MA)
- …costs. This role requires strong analytical skills, strategic thinking, and the ability to lead and mentor a team. Key to this role is the ability to develop ... industrial sectors. We are rapidly investing in our technology, equipment, and global services platform to help our industrial customers achieve their most ambitious… more
- State Street Corporation (Boston, MA)
- Who we are looking for The Global Liquidity Management (GLM) Group, within the Global Treasury organization, oversees State Street's liquidity planning, ... monitoring, analytics, and regulatory reporting globally. The group manages regulatory ...and associated public disclosures. We work collaboratively with the Global Treasury Risk Management (GTRM) function to ensure we… more
- Curaleaf (Wakefield, MA)
- …cannabis company by consistently delivering superior products and services and driving the global acceptance of cannabis. Our Values: Lead and Inspire. Commit to ... strong commitment to quality, expertise, and innovation. As a leading global cannabis provider, our brands-including Curaleaf, Select, and Grassroots-offer premium… more
- Wellington Management Company (Boston, MA)
- …compliance frameworks and processes, with a primary focus on the global screening program. Lead initiatives to enhance enterprise-wide technology ... comprehensive investment management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the unique return… more
- Cedent (Boston, MA)
- …CFR Parts 11, 50, 54, 56, 312/812), ICH GCP guidelines (E6(R3)), and global regulatory requirements. Key Skills & Competencies Technical Expertise Regulatory ... CRO Regulatory Specialist Job Description The Regulatory ...adherence Conduct GCP compliance assessments and site readiness evaluations Lead the implementation of risk-based monitoring strategies Coordinate CAPA… more
- LanceSoft (Cambridge, MA)
- …cross functionally and leading the development of required processes (eg, with Global Regulatory Affairs, Data Sciences). Ensures that Client Signal Management ... and activities are compliant with EU regulations and EU regulatory authority and inspectors' expectations. Principal responsibilities include: Technically fully… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …is true to the best of my knowledge. Job Description OBJECTIVES: Global Evidence and Outcomes (GEO) contributes to the successful development and commercialization ... development and evidence generation programs Key position objectives are to: Lead the design, conduct, analyses, interpretation and communication of real-world… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …you to shine? Join us as a Product Manager, Data Quantitative Sciences & Global Regions Data, Digital & Technology (DD&T). At Takeda, we are transforming the ... people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for… more
- Deciphera Pharmaceuticals (Waltham, MA)
- …in the Waltham office. The Medical Director is responsible for global pharmacovigilance (PV) for marketed and/or investigational products, including review and ... and external meetings. May be appointed as the Safety lead for a specific compound / product. The successful...drive conclusions and develop next steps Work closely with Regulatory Affairs, and other cross functional team members to… more
- Takeda Pharmaceutical Company Limited (Boston, MA)
- …development of internal functional processes and training and ensure alignment with global processes and regulatory requirements and expectations. Drive the ... and tools to enable execution of CPMQ activities, ensuring alignment with global processes and regulatory requirements. Create and deliver training solutions… more
- Medtronic (Boston, MA)
- …at the link below: Medtronic benefits and compensation plans About Medtronic We lead global healthcare technology and boldly attack the most challenging health ... and innovation, while helping champion healthcare access and equity for all. You'll lead with purpose, breaking down barriers to innovation in a more connected,… more
- DynamiCure Biotechnology (Waltham, MA)
- …contributing to the medical function, including designing, implementing, and communicating global clinical development plans for our vascular normalization and tumor ... interactions with key academic advisors, principal investigators, patient groups, regulatory authorities, academic and industry collaborators as well as DynamiCure's… more
