- Repligen (Waltham, MA)
- …global public company is looking for a strong, experienced, and technically sound Senior Director , Assistant Controller, who will own the Company's accounting ... reporting (ICFR) in compliance with Sarbanes-Oxley (SOX) requirements.Ensure compliance with accounting standards and regulatory requirements, including SEC… more
- Repligen (Waltham, MA)
- …, Quality - Quality Network Leader, Chromatography & Proteins.ResponsibilitiesThe Director , Quality will be responsible for:Maintaining site compliance ... OverviewWe are seeking an experienced Director of Quality candidate to lead Repligen's Waltham,...deviation support, root cause analysis, customer complaint management, hosting customer/ regulatory audits and Certificate of Quality generation at an… more
- Repligen (Waltham, MA)
- …(including foot notes); knowledge relating to SEC filing requirements and regulatory compliance advantageous.Strong technical accounting skills with expertise in ... role requires expertise in SEC reporting, US GAAP, and financial controls. The Director will work closely with senior leadership, auditors, and cross-functional… more
- Merck & Co. (Boston, MA)
- …leader to drive pipeline impact and lead a talented group of pharmacometricians.This Senior Director is expected to be an experienced pharmacometrician with a ... and Simulation (M&S) tools in decision making to drive pipeline impact. The Senior Director will take on primary responsibilities for identifying emerging areas… more
- Clinical Dynamix, Inc. (Waltham, MA)
- …need for a Contractor to be in place asap)! Reporting to the Sr. Director , Clinical Excellence Operations the Senior Manager/Associate Director , Records ... all therapeutic areas of development at Company. The Associate Director of Records Management will provide direct management and...ensuring goals and timelines are met with quality, in compliance with SOPs and regulatory guidelines. Identifies… more
- Takeda Pharmaceutical Company Limited (Lexington, MA)
- …IIR within assigned TA in accordance with all applicable internal legal and compliance policies as well as external US-specific regulatory guidelines. Partners ... development (eg, thru Patent Exclusivity expiration). Thorough understanding of legal, compliance , and regulatory guidelines related to the conduct of… more
- TransMedics (Andover, MA)
- …and testing for the Next Generation Organ Care System while ensuring compliance with project requirements and regulatory standards. Provide leadership, oversight ... developed to maximize the utilization of donor organs in the US. As our Director of Electrical & Systems Engineering at TransMedics you will have the unique… more
- Ardelyx (Waltham, MA)
- …for GCP/GLP/PV regulatory inspections. Other responsibilities include the provision of regulatory compliance and QA guidance to clinical and drug safety ... Pharma. Knight Therapeutics commercializes IBSRELA in Canada. Position Summary: Reporting to the Senior Vice President of Quality, the Executive Director of GCP,… more
- Glycomine (Boston, MA)
- …ensuring adherence to contractual agreements, timelines and quality standards Ensure compliance with regulatory requirements, ICH-GCP requirements, and company ... of life for patients, caregivers, and families. Job Description The Senior Clinical Project Manager/Clinical Project Manager is a team-player role responsible… 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 ... be responsible for the development of an inspection program for site compliance and maturity, inspection preparation, consistent state of readiness and inspection… more
- Applied Research Solutions (Bedford, MA)
- ARS is seeking a Senior Program Execution Group (PEG) Manager supporting the NC3 Contract, specifically the AFNWC/NC3 Integration Directorate (NC). The NC3 ... at Kirtland AFB, NM, supports the Program Executive Office (PEO), the Deputy Director , Deputy AFPEO NC3, and staff with acquisition and administrative control across… 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...drives our values, behaviors, and creativity. Your Responsibilities: The Senior Manager of IT Operations, Infrastructure, and Security (SM… more
- Manchester School District (Manchester, NH)
- …Core Function: Work within the Human Resource area to support in maintaining compliance with Human Resources policies and procedures, work with all levels of ... Areas of focus include recruiting, onboarding of new hires, reporting and compliance , workers compensation and managing employee medical leaves such as FMLA,… more
- Takeda Pharmaceuticals (Boston, MA)
- …and representing the regulatory function on cross-functional Global Program Teams. The Senior Director also will lead discussions of regulatory strategy ... order to bring life-changing therapies to patients worldwide. The Senior Global Regulatory Affairs, Neuroscience is responsible...success for the mitigation strategies proposed. + The Sr Director / Director will be accountable for all US… more
- Takeda Pharmaceuticals (Boston, MA)
- … strategies in collaboration with their regional counterparts. **_Accountabilities:_** + The Senior Director will be responsible for complex or highly complex ... regulatory strategy is updated and executed, ensuring global regulatory compliance . + Ensures global regulatory...or oversees direct reports or other staff responsible. The Senior Director will lead all submission types.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …and guidelines. Apply and adapt this understanding to projects to enhance probability of regulatory success and regulatory compliance . Ability to draw from ... a GRA CMC member, ensures and / or enhances regulatory compliance . + Ensures project team colleagues,...timely manner. Acts as an advisor and liaison to senior management. + As a member of the modality… more
- Takeda Pharmaceuticals (Boston, MA)
- …Regulatory , and Pharmacovigilance domains. + Strong understanding of global regulatory and safety compliance requirements and technologies supporting ... **Objective / Purpose:** The Head of Design & Delivery, Development & Regulatory will lead the global technical product strategy across Takeda's development… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. Join Takeda as Director , Global Regulatory Labeling Strategy where you will be responsible for ... alignment of the labeling strategy and labeling content. **Interface with Senior Management Cross-Functional Team (GLOC)** + In alignment with TAU/MPD Labeling… more
- Takeda Pharmaceuticals (Boston, MA)
- …in order to bring life-changing therapies to patients worldwide. The Associate Director , Global Regulatory Affairs Advertising and Promotion (GRA A&P) Review ... promotion. **How you will contribute:** + As our Associate Director , Global Regulatory Affairs Advertising and Promotion...if there is new data or campaigns that require senior level management input or alignment. + Strategic business… more
- Sumitomo Pharma (Boston, MA)
- …seeking a dynamic, highly motivated, and experienced individual for the position of ** Director , Regulatory Advertising & Promotion** . The Director is ... encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and… more
