- BioAgilytix (Durham, NC)
- …you enable life-changing, life-saving therapeutics to the patients who need them.The Regulatory Affairs Manager is responsible for coordinating the regulatory ... and life cycle management. This includes development and implementation of regulatory strategies and timelines as well as the preparation of submissions.Essential… more
- DivIHN Integration Inc (North Chicago, IL)
- …regulatory support Stakeholders: Direct interaction with RA functions including Regulatory Operations, Submissions Execution, Regulatory Project ... interactions to expedite approval of pending registration. Participates/ Awareness on project plans, regulatory submission strategy, any risks management.… more
- DivIHN Integration Inc (Green Oaks, IL)
- … scientific affairs, operations, or related area. Experience with Regulatory history, guidelines, policies, standards, practices, requirements and precedents; ... Talent Specialists Meghna at ### Rashi at ### Title: Regulatory Affairs Specialist Location: Abbott Park, IL Duration: 7...creativity and latitude is expected. Typically reports to a manager or head of a unit/department. Main purpose of… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division ... organization of our company.- Position Description/Summary: The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or Late… more
- DivIHN Integration Inc (Lake Forest, IL)
- …Forest, IL Duration: 7 Months Description Exempt/Non Exempt: Non exemptYears. Duties: Manager regulatory submissions ot ensure timely regulatory approval ... project teams. Ensure all client product and procedures comply with applicable regulatory agency requirements and guidelines. Manager is Insun Ho Start date… more
- DivIHN Integration Inc (Chicago, IL)
- …Talent Specialists Rashi | 630 8471027 Divya | 224 369 2969 Title: Medical Manager Location: Remote role but need local to Illinois Duration: 11 months Start Time ... development, contract negotiation, site recruitment, support program management for project reviews, budget and timeline development, establishing relationships with… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …about grant activity to stakeholders in an accurate and timely fashion. The Grants Manager will rely heavily on their strong project management skills; ability ... through Northeast Georgia Medical Center graduate medical program. As the research manager , responsible for project management of many projects in different… more
- Novo Nordisk Inc. (Durham, NC)
- …the stability portfolio for all products, and writing and maintaining regulatory documentation. Relationships Director. Essential Functions Lead, drive & coach teams ... & oral communication skills & the ability to author scientific & technical reports is required Organization/Planning: Proven expertise...members & other teams Ability to lead task & project teams Ability to manage a changing work environment… more
- Merck & Co. (Rahway, NJ)
- …of resources by setting priorities (in agreement with line function & Project Manager ).-Ensure availability of regular reports concerning results, costs, budgets ... represent the group in internal meetings, in meetings with regulatory agencies and in scientific meetingsWorking knowledge...and provide updates (line function and Project Manager ) routinely.-Ensure an overall high quality… more
- Sunrise Systems Inc (New Brunswick, NJ)
- …CMC regulations Experience in post-approval requirements Experience in developing CMC regulatory strategy Experience in project management Have a ... PREREQUISITES BS/BA degree in Scientific Discipline (master's or higher preferred) with 5+...in the pharmaceutical industry, preferably with 3+ years CMC regulatory experience Skills/Knowledge Required: Experience with CMC regulatory… more
- Southwest Research Institute (Ann Arbor, MI)
- …control and data acquisition solutions.Coach your team to develop technical, project management and business development skills.Develop and grow your engineering ... and emission reducing technologies. Daily and Monthly Responsibilities: Guide and support project managers and engineers to ensure projects are completed on-time and… more
- Novo Nordisk Inc. (San Antonio, TX)
- …of quality clinical research (patient safety, rights and wellbeing; data reliability; scientific integrity; regulatory and process compliance) for monitoring and ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...leveraging competencies, tools and technology. Relationships Reports to a Manager (or above) within NACD. Manages mutually beneficial relationships… more
- Northeast Georgia Health System, Inc (Gainesville, GA)
- …in-services.Performs related responsibilities as required.Consults with the Research Manager regarding the study implementation process.Study Initiation: Plan, ... completion of the study. Manage and communicate effectively with Research Manager regarding proposed projects for feasibility, including, analyzing scope of work,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Project Manager within the Strategy Realization Office (SRO) function of GMSA at our company, the successful applicant will play a critical ... and timelines are consistently met.Facilitate the creation and approval of all project deliverables, including maintaining detailed Project Plans, Risk Plans,… more
- Integrated Resources, Inc (Woodbury, NJ)
- …in training hospital management and/or staff and is responsible for evaluating the project effectiveness and outcome. Manager is a key player in performance ... Woodbury, NJ Duration: 18 Months+ Job Description: . The Hospital Laboratory Manager is responsible for all Hospital Laboratory Management and delivering on contract… more
- Jacobs (Scoville, ND)
- …full-time Subcontractor Quality Representative (SQR) who will report directly to the Project Quality Assurance Manager (PQAM) and support the field-related ... Jacobs provides a full spectrum of professional services including consulting, technical, scientific , and project delivery for the government and private sector.… more
- George Washington University (Washington, DC)
- …and can perform a variety of research tasks. This position typically reports to a project supervisor or project manager and may provide guide to lower-level ... the Principal Investigator. This position will assume general responsibility for general scientific operations in the lab, and/or provide guidance to junior staff,… more
- Careerbuilder-US (Houston, TX)
- …detail and organizational abilitiesFamiliarity with quality management systems and regulatory requirementsStrong project management skillsStrong problem solving ... Overview Job Title: Technical Trainer & Writer Reporting Relationship(s): Engineering Manager and VP of Operations Job Summary: Responsible for documenting and… more
- ThermoFisher Scientific (Wilmington, NC)
- … Delivery is vital to helping our customers deliver life-changing therapies. Role: Senior Project Manager OR Project Manager Location: Remote, Homebased, ... North America Discover Impactful Work: We are seeking a Project Manager /Lead in within our Functional Service... team compliance with organization policies, SOPs, ICH- GCP, regulatory and project specific requirements. Keys to… more
