- WM (Boston, MA)
- …Stability. Growth Opportunities. People-First Culture (https://www.wm.com/us/en/inside-wm/who-we-are) . **About the Regulatory and Compliance Manager Role** ... The Regulatory and Compliance Manager for WMSS PharmEcology Services is responsible for leading...+ Apply EPA, DEA, DOT, and OSHA regulations to pharmaceutical waste to ensure compliance standards are… more
- Takeda Pharmaceuticals (Boston, MA)
- …CCDS, USPI and EU SmPC enabling the most up-to-date information and in compliance with labeling requirements to be provided to patients and Health Care Providers ... negotiations with Health Authorities. + Ensures labeling content conform to regulatory requirements. Management of Local Exceptions and LOC Interactions + Manages… more
- Boston University (Boston, MA)
- …standards and adheres to best practices. The Clinical Research Resources Office (CRRO) Regulatory Education Manager will manage two important aspects of the ... (PIs and study staff). Education will promote understanding and compliance with the regulations, guidance's , policies and best...of the clinical/human research team. The Human Research Education Manager works within the CRRO (under the Office of… more
- Takeda Pharmaceuticals (Boston, MA)
- …regulations to ensure CMC compliance within the organization + Lead regulatory compliance assessment with respect to filing requirements for assigned ... bring life-changing therapies to patients worldwide. Join Takeda as a Director, Regulatory Affairs Vaccines CMC where you will provide program leadership and develop… more
- Hologic (Marlborough, MA)
- …degree preferred. + Minimum of 5-7 years of experience in medical device/ pharmaceutical compliance , with a strong understanding of applicable laws, regulations, ... Manager , Compliance Operations Marlborough, MA, United...program and will be responsible for ensuring adherence to regulatory requirements and industry standards and overseeing and managing… more
- Fresenius Medical Center (Waltham, MA)
- … compliance . Develops, coordinates, reviews and prepares documentation packages for pharmaceutical regulatory submissions (Primarily US). May act as FDA ... + Ensures that all submission documentation, record keeping and reporting remain in compliance with regulatory filings and in accordance with current … more
- Gilead Sciences, Inc. (Boston, MA)
- …motivated, passionate individual to join the US Site Qualification team as Senior Manager , Quality Assurance in the exciting new area of CAR-T cancer immunotherapy. ... centers (ATCs). + Perform a variety of audits to qualify and monitor compliance to ATC qualification requirements. + Represent Quality in the routine management of… more
- Nanobiosym, Inc. (Cambridge, MA)
- …knowledge of applicable regulations, providing consultation to staff regarding regulatory compliance . Qualifications Qualifications * Minimum 8 years' ... and requirements are below. The CLIA (Clinical Laboratory Improvement Amendments) Quality Manager will provide quality and compliance oversight to the Nanobiosym… more
- Takeda Pharmaceuticals (Boston, MA)
- …Brand teams prioritization, forecasting and budgeting process. + Liaise with legal, regulatory and compliance to ensure all marketing activities are compliant ... As a member of Takeda Oncology, as a Senior Manager , your work will contribute to our bold, inspiring...Values & Access, Customer Experience and Insights, Ethics and Compliance , and external partners. **How you will contribute:** +… more
- AbbVie (Waltham, MA)
- …R&D, or Industry-related experience. + Preferred Experience: 2-3 years in pharmaceutical regulatory activities + Demonstrates excellent negotiation skills, ... products with multiple driver indications within a Therapeutic Area and supports the Manager (Global Regulatory Lead (GRL), Associate Director, or Director), in… more
- Sumitomo Pharma (Boston, MA)
- …employee encounters is considered confidential. ** Compliance ** :Achieve and maintain Compliance with all applicable regulatory , legal and operational rules ... **Title: Sr. Manager , Medicaid Contract Administration** **Location: Remote/occasional onsite (if...with internal departments (Internal Audit, Commercial Insights, Contracting, SOX Compliance , and Legal) to clarify policy compliance … more
- Pfizer (Cambridge, MA)
- … Compliance , R&D Legal, Corporate Compliance , Worldwide Safety & Regulatory and Pharmaceutical Sciences and other key study team members such as ... Description** Drive GCP quality in documentation, operational data and withstanding regulatory scrutiny. This position will focus primarily in Trial Master File… more
- Pfizer (Cambridge, MA)
- …with others within clinical teams, partner lines (such as, Development Operations, Pharmaceutical Sciences, Safety Risk Management, Regulatory ), and external ... Ensure that all study and project level statistical activities are conducted in compliance with relevant regulatory requirements and Pfizer standards. + Provide… more
- BioLife Plasma Services (Boston, MA)
- …the business and industry, and build your skills by contributing to regulatory compliance , donor suitability, product release, inspection readiness, employee ... application is true to the best of my knowledge. **Job Description** ** Manager ** **Trainee -** **Quality** **(Travel and Relocation Required)** Here is your… more
- Takeda Pharmaceuticals (Boston, MA)
- …and document CRO site qualification visits to monitor programs, study quality and compliance with site SOPs, regulatory and animal welfare guidelines, as ... you and empower you to shine? At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …charge of your future at Takeda. Join us as aR&D Digital Health Product Manager in our Cambridge, MA office. At Takeda, we are transforming the pharmaceutical ... strategy and bring relevant stakeholders together. + Coordinate, align, and ensure compliance , user- experience, scalability, quality, and guide the teams towards a… more
- Editas Medicine (Cambridge, MA)
- …Summary The Editas Facilities & Engineering team is looking for a Senior Manager of Metrology & Lab Systems Maintenance. This individual, reporting to the Senior ... good documentation is executed. Key Responsibilities: As the Senior Manager , you will be responsible for: + Responsible for...managing personnel. + Thorough knowledge of cGMP in the pharmaceutical industry + Expert knowledge of pharmaceutical ,… more
- Actalent (Lexington, MA)
- …Testing + Biologics + CMC Soft Skills + Collaboration + Troubleshooting + Regulatory Compliance + Quality Assurance + Documentation Management Job Type This ... transfer of testing methods and assays, and troubleshoot as necessary. Ensure strict compliance with regulatory standards including FDA, EMA, and other agencies.… more
- Ophthalmic Consultants of Boston (Waltham, MA)
- Ophthalmic Consultants of Boston (OCB is currently searching for a Practice Manager to join the Retina division. Summary of Responsibilities: The Practice Manager ... patient care, and fulfillment of OCB's objectives and goals. Practice Manager establishes effective strategies to maximize patient, provider, and staff satisfaction.… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- The Business Analysis & Operations Senior Manager will drive consistency across the Global Development (GD) IT team & IT community. This role will be a key team ... & Procedures and Research IT teams members. As a Global Development IT Sr Manager (Business Analysis & Operations), a typical day might include: + Function as point… more