- Repligen (Waltham, MA)
- … public company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting ... processes including all global subsidiaries. Reporting directly to the VP Corporate Controller,...accordance with GAAP.Ensure timely and accurate financial reporting to senior management and external stakeholders, including quarterly and annual… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …application is true to the best of my knowledge. Job Description Associate Director , Clinical Research, Value & Evidence Generation, US Medical Lexington, MA Hybrid ... on issues and focus on effective contingencies; interfacing with senior management and influencing decision-making, monitoring slippage and developing strategies… more
- Leica Biosystems (Boston, MA)
- …digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission work ... Biopharma sector.This position reports to the Director , Regulatory Affairs and is part of the Global...issues, and risks in written and verbal format to regulatory senior leadership team and other governing… more
- Vertex Pharmaceuticals (Boston, MA)
- Job Description General Summary: The Senior Director of External Manufacturing Operations (Drug Product), provides vision, leadership and management of Vertex's ... and execute creative solutions to organizational opportunities and challenges. The Senior Director of External Manufacturing Operations reports directly to… more
- Wellington Management Company (Boston, MA)
- …that aligns our perspectives with those of our clients. About the Role The Director , Global Benefits Operations is a strategic and hands-on leadership role ... management capabilities that span nearly all segments of the global capital markets. Our investment solutions, tailored to the...Head of Total Rewards, HR Business Partners, Finance and senior leadership to ensure benefit programs align with the… more
- Fidelity Investments (Boston, MA)
- Job Description: Senior Associate - Global Financial Controls Center of Excellence The Global Financial Controls Center of Excellence (GFC-CoE) is an ... processes, and systems. This role will report to a Senior Manager or a Director within the...financial activities and the rules and regulations of numerous self- regulatory organizations, including FINRA, among others. Those laws and… more
- BioSpace (Cambridge, MA)
- …Knowledge Therapeutic area knowledge relevant to mechanism of action Regional/ global Regulatory requirements Emerging research in designated therapeutic ... of your future at Takeda. Join us as a Senior Medical Director - GI & Inflammation- Rheumatology,...Director leads and drives strategy for the overall global (US/EU/Japan) clinical development taking into consideration the medical,… more
- Glycomine (Boston, MA)
- …of life for patients, caregivers, and families. Job Description The Senior Clinical Project Manager/Clinical Project Manager is a team-player role responsible ... through all phases of clinical trials (Phase I-III). The Senior Clinical Project Manager/Clinical Project Manager is a role...prior to each site activation. Work closely with the Director of Clinical Operations to review the study timelines… more
- Vertex Pharmaceuticals (Boston, MA)
- Job Description General/Position Summary The Director , CMC Inspection Management as part of the Vertex Quality Assurance Organization is responsible for the ... (CAPAs) in response to audit and inspection findings. Collaborates with the Global Quality Audit and Inspection Management to enable execution and maturity of… more
- Azzur Group (Boston, MA)
- Senior Manager, Infrastructure Operations & Security (Contract/Hybrid*3 days per week in the Office) Senior Manager, Infrastructure Operations & Security (Temp ... to Perm) Reporting to: Associate Director , IT Operations, Infrastructure and Security Do you have...much left to do! We are continuing to explore global opportunities for mavorixafor in its first indication, while… more
- Goodwin Procter LLP (Boston, MA)
- Join Goodwin's Global Operations Team, and make a real impact on a global scale. At Goodwin, we work with some of the world's most successful and innovative ... technology and financial industries, and where they converge. As part of the Global Operations Team - all business professionals at the firm - you'll collaborate… more
- Bristol-Myers Squibb Company (Devens, MA)
- …to the Devens site. This position will report to the Associate Director , Process Technical Operations. The successful candidate will leverage technical ability, ... concepts for all aspects of investigations. Actively participates in global investigations process activities (eg SOP review, improvement initiatives). Proactively… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory Teams (GRTs) and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead ... order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs, Neuroscience...success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US… more
- Takeda Pharmaceuticals (Boston, MA)
- …my knowledge. **Job Description** **_Objective / Purpose:_** + Defines, develops and leads global strategies to maximize global regulatory success towards ... and influencing the field as applicable. + Provides leadership and development for other global regulatory leads responsible for the design and execution of … more
- Takeda Pharmaceuticals (Lexington, MA)
- …and approves - as needed - technical protocols, reports, etc. to ensure alignment with global regulatory requirements and standards. + When in a GRA CMC Product ... timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality...regulatory guidance to product teams in line with global regulatory strategies. Accountable for development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …of the Global Regulatory Affairs CMC team, you will report to the Senior Director Global Regulatory Affairs CMC. **How you will contribute:** + ... meetings, international experience preferred. + Understanding of scientific principles and regulatory CMC requirements relevant to global drug development and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be ... coordinates the process to obtain labeling approval by Labeling Senior Management Cross-functional team ( Global Labeling Oversight...issues to Global Labeling management and the Global Regulatory Lead (GRL) and proposes risk… more
- AbbVie (Waltham, MA)
- …. Job Description The Director , Oncology Business Development and Global Regulatory Strategy is responsible for developing and implementing globalstrategies ... maintain market approval for product(s) in the assigned therapeutic area. Leads the Global Regulatory Product Team (GRPT). Continually expands TA knowledge, and… more
- Takeda Pharmaceuticals (Boston, MA)
- …possible in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA ... promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Fresenius Medical Center (Waltham, MA)
- …+ ** Regulatory Strategy Leadership:** + Lead the development of global regulatory strategies for the company's pharmaceutical portfolio, including IND/CTAs, ... NDAs, NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership...potential risks to inform decision-making across the organization. + ** Global Regulatory Submissions:** + Oversee the planning,… more
