- Repligen (Waltham, MA)
- …mitigation strategies.Build and maintain strong relationships with external auditors, regulatory agencies, and industry peers.Operational Excellence: Lead root ... the SOX program. Shape and execute compliance strategy across a global company Lead SOX risk assessments, audits, and remediation efforts Partner with senior leaders… more
- Merck & Co. (Boston, MA)
- …leading squads and maintaining product lifecycle Manage scientific applications and lead squads to build user-friendly scientific data and technology ... in R&D IT brings together product management, engineering, and data science expertise. We enable data , technology...the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line.… more
- Merck & Co. (Boston, MA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... Director will perform job duties independently with minimal supervision and/or lead QP2 efforts on drug/vaccine development programs, and author or co-author… more
- Merck & Co. (Boston, MA)
- …and Diagnostics, in this role, you will serve as the translational lead on late-stage immunology programs, driving the Precision Medicine objectives in alignment ... be the authority in defining and interpreting the translational experiments and data generated respectively from our clinical trials, and understanding the potential… more
- Lundbeck (Boston, MA)
- …Join us on our journey of growth! As a Psychiatry Account Manager, you lead the promotion of our psychiatry portfolio, executing sales and marketing strategies with ... Planning & Account Leadership - Ability to use digital tools and apply data -based insights to create opportunities, develop strategy & tactics, allocate resources to… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Lead , Regulatory Data **Location** : Cambridge, MA, Morristown, NJ **About the Job** Are you ready to shape the future of medicine? The race ... Lead role is the business owner for the regulatory data migration at an operational level...**Main Responsibilities:** Primary areas of responsibility include: + The Lead , Regulatory Data role provides… more
- Takeda Pharmaceuticals (Boston, MA)
- …following job opportunity: **JOB LOCATION:** Cambridge, MA **POSITION** : Associate Director, Regulatory Data Governance Lead **POSITION DESCRIPTION** : ... Takeda Development Center Americas, Inc. is seeking an Associate Director, Regulatory Data Governance Lead with the following duties: Oversee the… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …product-related issues; Direct US and Global ENTYVIO issues and crisis management. + Lead communications for data and regulatory milestones, including ... company that will inspire you and empower you to shine? Join Takeda as the Lead (Associate Director), ENTYVIO(R) Communications in Cambridge, MA. + As the Lead … more
- Takeda Pharmaceuticals (Boston, MA)
- …therapies for patients with immunologic, hematologic, and other complex diseases. The Regulatory Lead is accountable for recommending and implementing ... activities across the portfolio of PDT products. The Global Regulatory Lead , Director, in PDT R&D: +...meets budget and deadlines + Builds a culture of data driven decisions + Ability to challenge self and… more
- Takeda Pharmaceuticals (Boston, MA)
- …life-changing therapies to patients worldwide. Join Takeda as Associate Director Global Regulatory Lead , GRAD Oncology. You will provide strategic and tactical ... staff responsible. + May serve as global and/or regional regulatory lead as a member of a... requirements and strategy. + Understands and interprets scientific data as it relates to regulatory requirements… more
- Takeda Pharmaceuticals (Boston, MA)
- …influence in or leads departmental and cross-functional task-forces and initiatives. + Lead regulatory reviewer in due diligence for licensing opportunities. + ... and business needs and anticipates such changes to lead adaptations to regulatory strategy. + Ensures... requirements and strategy. + Understands and interprets scientific data as it relates to regulatory requirements… more
- Sanofi Group (Cambridge, MA)
- **Job Title:** Global Regulatory Lead **Location** : Morristown, NJ, Cambridge, MA **About the Job** Are you ready to shape the future of medicine? The race is ... Your skills could be critical in helping our teams accelerate progress. The Global Regulatory Affairs Lead (GRL) is the fully accountable decision maker for the… more
- Deloitte (Boston, MA)
- …Limited immigration sponsorship may be available Preferred: + Understanding of pharmaceutical regulatory data and regulatory filing requirements and ... to build, deploy, and operate integrated/verticalized sector solutions in software, data , AI, network, and hybrid cloud infrastructure. These solutions are powered… more
- Avanade Inc. (Boston, MA)
- Lead the Future of Data , AI,...two industry events to amplify Accenture's market voice. * Regulatory & Compliance Advisory - Guide clients on HIPAA, ... data , AI, and bold digital experiences. As our Data , AI, and Digital Experience Advisory Presales Lead...coaching, OKR roll outs, and Prosci/ADKAR adoption programs. * Regulatory & Risk Advisory * Advises boards/CROs on AI… more
- Sanofi Group (Cambridge, MA)
- … Affairs (GRA) Device Head, Specialty Care Device and Combination Products will lead a team responsible for device regulatory activities associated with Sanofi's ... was possible. Ready to get started? **Main Responsibilities:** + Lead , supervise and coach a team of regulatory...project strategies + Ability to synthesize and critically analyze data from multiple sources + Ability to travel internationally… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …Manager works under the Director of Clinical Regulatory Compliance to lead initiatives related to compliance, including data analysis and reporting for ... + Evaluate and Implement New Regulatory Requirements: Analyze new regulatory requirements, prepare summaries and recommendations, and lead initiatives to… more
- Takeda Pharmaceuticals (Boston, MA)
- …our Global Regulatory Affairs organization, based remotely. + Partners with the Global Regulatory Lead (GRL) on Global Regulatory Teams (GRTs) to ensure ... you will contribute:** + Partnering with the program Global Regulatory Lead (GRL), co- lead and...regulatory information management systems, preparing, checking and tracking regulatory data and lists etc.) + Prepare… more
- Deloitte (Boston, MA)
- …implementation and automation of reporting processes, testing and validating reporting data , developing quality assurance programs, and remediating regulatory ... industry perspectives, lead generation materials, and proposals The Team Our Regulatory & Financial Risk offering supports clients' regulatory and compliance… more
- Sanofi Group (Cambridge, MA)
- …Regulatory Team (GRT) for the Innovation Franchise and strategic partner to the Global Regulatory Lead (GRL), the Regulatory Strategist (RS) will play a ... thought was possible. Ready to get started? **Main Responsibilities:** + Enables the Global Regulatory Lead (GRL) by providing quality regulatory input and… more
- Takeda Pharmaceuticals (Boston, MA)
- …with influence in departmental and cross-functional task-forces and initiatives. + Lead regulatory reviewer in due diligence for licensing opportunities. ... + Partner with global market access colleagues to Lead interactions with joint regulatory /health agency/HTA bodies... requirements and strategy. + Understands and interprets scientific data as it relates to regulatory requirements… more
