- Actalent (Cambridge, MA)
- Job Title: Regulatory Submissions Specialist Job Description We are seeking a highly skilled Regulatory Submissions Specialist to manage ... leads to create content plans and submission timelines for regulatory submissions . + Organize and facilitate kick-off...+ Serve as the point of contact and alliance manager for selected regulatory vendors, ensuring timely… more
- Dana-Farber Cancer Institute (Boston, MA)
- …established timelines. The AROM is directly responsible for closely managing all regulatory submissions reaching the activation phase to ensure both Clinical ... The Assistant Regulatory Operations Manager (AROM) is a...manage the delegation of quality assurance checks for iRIS submissions and assist with Regulatory -Coordinator onboarding, training,… more
- Medtronic (Woburn, MA)
- …Program Manager will lead the strategic planning and execution of regulatory submissions and compliance initiatives within the Advanced Surgical Technologies ... cross-functional teams, including R&D, Quality, Clinical, and Marketing, to drive regulatory submissions and maintain compliance throughout the product… more
- Takeda Pharmaceuticals (Lexington, MA)
- …across the business. **How you will contribute:** + Develops, executes and oversees regulatory submissions preparation per the GRA CMC Product Team CMC strategy. ... With minimal supervision, develops, plans, executes and manages regulatory submissions per the GRA CMC Product...according to agreed business priorities. + As a line manager role, provides project and administrative oversight to support… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager , Clinical Research Manager and / or ... of the clinical research project. The RC coordinates aspects of protocol submissions , prepares and submits regulatory documents, and maintains records on… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …of the clinical research project. The RC coordinates aspects of protocol submissions , prepares and submits regulatory documents, and maintains records on ... guidance and or local policies + Assists Clinical research Manager with regulatory based training and implementation...consent design and development and FDA IND and other regulatory required submissions **KNOWLEDGE, SKILLS, AND ABILITIES… more
- Actalent (Boston, MA)
- …to avoid deficit spending. As necessary, work with investigators and RAD to manager deficits. + Responsible for managing all time and effort reporting for defined ... proposal submission process including budget development for new and non-competing submissions . Advises investigators of grant policies, due dates for progress… more
- Dana-Farber Cancer Institute (Boston, MA)
- …of their program's research activities, providing training to research staff, regulatory submissions , and participant accrual tracking and reporting. The ... The Clinical Research Manager (CRM) will work within the Cohort Studies...clinical trials. + Identify and manage operational, logistical, and regulatory challenges related to the conduct of clinical trials… more
- Nanobiosym, Inc. (Cambridge, MA)
- …timely and compliant generation of clinical and validation data required to support regulatory submissions for all new products and modifications to existing ... up its operations. Nanobiosym is looking for a Quality Manager for its High-Complexity Testing CLIA LAB. The role...program for the CLIA laboratory in accordance with the regulatory standards and the quality management system at Nanobiosym.… more
- Dana-Farber Cancer Institute (Boston, MA)
- …startup activities, providing training to participating site research staff, regulatory submissions , safety event tracking and reporting, deviation/violation ... at Dana-Farber Cancer Institute is seeking to hire a motivated Research Project Manager to work within the Clinical Translational Research Program (CTIP) on trials… more
- Harvard University (Cambridge, MA)
- …monitoring of ongoing clinical research studies to ensure protocol and regulatory compliance with Good Clinical Practices and other applicable regulations. + ... and submit documents to Institutional Review Boards (IRBs) and other governing/ regulatory bodies, including, but not limited to, reliance agreements, research… more
- Fresenius Medical Center (Waltham, MA)
- …management system. + Manages document producing, publishing and tracking for company regulatory submissions and submissions -complaint documents in support of ... legacy to electronic submissions . + Coordinates with regulatory staff to compile regulatory submissions...years' related experience. + 3+ years' experience as a Manager preferred. + Demonstrated ability to manage one or… more
- Dana-Farber Cancer Institute (Boston, MA)
- …research assistants / coordinators, and study clinicians. + Responsible for regulatory submissions to institutional review board. + Responsible for ... **Division of Population Sciences** is seeking a **Senior Research Project Manager ** to oversee a portfolio of research testing behavioral interventions designed… more
- Dana-Farber Cancer Institute (Brighton, MA)
- …start-up activities, coordinating and managing site activation, research staff training, regulatory submissions , event tracking and reporting, deviation and ... The Research Project Manager (RPM) is responsible for assigned day-to-day coordination...field is preferred. + Must have strong knowledge of regulatory affairs, research ethics and the responsible conduct of… more
- Dana-Farber Cancer Institute (Boston, MA)
- …managers and scientists. 9. Drafts business plans and strategic documents. 10. Performs regulatory tasks related to IND submissions and annual reports for ... The Translational Research Project Manager (TRPM) oversees the management of the Pediatric and Young Adult Cancer Cell Therapy Program at Dana-Farber Cancer… more
- Philips (Cambridge, MA)
- …EMR data, for clinical and/or pre-clinical product portfolio decisions, marketing, regulatory agency submissions , and product reimbursement strategies to drive ... ** Manager Health Economics & Outcomes Research** (Cambridge, MA....negotiations, reimbursement, and patient access with global payers and regulatory decision makers. Support the development of cost-effectiveness and… more
- Unilever (Boston, MA)
- Brand Manager Boston, MA (http://maps.google.com/maps?q=One+Design+Center+Place+Boston+MA+USA+02210) Description Diversity is a core value at Living Proof. We are ... deliver solutions. Equal Opportunity/Employer/Veterans/Disabled. Living Proof is seeking a Brand Manager . This position is responsible for working with the team on… more
- Sumaria Systems, Inc. (Bedford, MA)
- Senior Program Manager - Department: SAS DAYTON, OH Office: Hanscom AFB - SAS Location: Bedford, MA START YOUR APPLICATION ... (https://apply.hrmdirect.com/resumedirect/ApplyOnline/Apply.aspx?req\_id=3247574&source=3247574-CJB-0) Job Title: Senior Program Manager Job Description: Sumaria prides itself on delivering efficient… more
- Guardian Life (Boston, MA)
- …government exchanges. **You Will:** In this role, the Retail Channel Operations Manager will be responsible for supporting the Partnerships and Exchange channels of ... segment + Conducting competitive analysis on pricing, features, and impact of regulatory trends + Providing operational support for the partnerships channel, which… more
- Editas Medicine (Cambridge, MA)
- …knowledge + Author and review of technical reports, SOPs, work instructions and regulatory submissions as needed + Maintain abreast latest industry trends for ... passion to educate and collaborate with others. Characterizing Your Impact: As the Manager , mRNA Process Development you will: + Drive the execution of Process… more