Reporting to the Director of Regulatory Affairs, responsible and accountable for developing and implementing sound strategies for complex regulatory submissions for functional unit. Assesses regulatory pathways for new product platforms and product modifications; develops regulatory strategies and t...
Develops regulatory strategies for moderately to highly complex submissions to FDA and other regulatory agencies. Provides risk assessments of strategies and regulatory options to business teams and to product development/support teams. Represents the business in interactions with regulatory authori...
The Compliance Analyst will also support the LGA Compliance team with regulatory filings, training and L&G Group related deliverables as assigned. The Compliance Analyst is responsible for maintaining producer red flag guidelines and revising these guidelines in partnership with Licensing and Distri...
THE ARMY HEALTH CARE ADVANTAGE.As a member of the Army health care team, you’ll receive benefits that you won’t be able to get in a civilian career.Feel inspired with great case diversity and over 40,000 visits coming into the U.Army medical facilities and clinics around the world every day.See and ...
Quality Assurance Specialist IV. The Vaccine, Immunity and Cancer Directorate is seeking an energetic, collaborative and seasoned Quality Assurance professional with experiences preferably in Serology laboratory setting with strong knowledge in GCLP to lead and support laboratory quality activities....
As a Staff Pharmacist, you have a critical role at the forefront of delivering our purpose, modeling our values, and demonstrating genuine, authentic care for our patients. This includes:Patient SafetyPharmacy Professional PracticeRegulatory RequirementsQuality AssuranceCustomer ServicePersonnel Man...
The honor of providing those in need with prescription medical services is yours as a Navy Pharmacist. As a Pharmacist and Navy Officer, you will be responsible for:. To qualify for active duty employment consideration as a Pharmacist in the Navy Medical Service Corps, you must meet these basic requ...
We are seeking a highly motivated, dedicated, and results driven Quality and Regulatory professional to join the team to fill a new leadership role supporting ancillary and cellular starting materials for the development and further manufacture of advanced therapy products in domestic and global mar...
The preferred candidate is a skilled project manager with 9 years of experience managing electrical design projects as prime or a subconsultant to other disciplines. Manage a team of engineers, designers, and project managers. Be responsible for project delivery of complete design packages, includin...
The Quality Assurance Compliance Specialist will work closely with the QA Manager and QA Supervisor to ensure company compliance with approved procedures and applicable regulatory standards. The Compliance Specialist will also work closely with clients and company suppliers to ensure quality standar...
The Senior Manager of Programs, Aviation will lead a team of Program Managers that oversee, coordinate, manage, and execute all activities associated with our Aviation vertical. Reports program status to all stakeholders, prepares and presents periodic status reports and monthly Program Management R...
As a Staff Pharmacist, you have a critical role at the forefront of delivering our purpose, modeling our values, and demonstrating genuine, authentic care for our patients. A key component of the Staff Pharmacist role is keeping your customers and patients healthy through adoption and management of ...
The Quality Assurance Specialist will ensure compliance with the quality system's procedures and identify and assess regulatory and quality risks in activities and processes according to regulatory agency guidelines and company quality objectives. Experience: </p> <ul> <li>BA/...
The Program Manager, Wellbeing Education and External Partnerships at the MedStar Health Center for Wellbeing (MCW) supports education strategy and implementation of internally and externally facing education, training, and certification programs at MedStar Health. MedStar Health is looking for a Pr...
The Pharmacy Program Manager position is a 100% remote role requiring a HIPAA-compliant workspace. A Pharmacy Program Manager is a Clinical Pharmacist providing pharmacist support for an interdisciplinary care management team and members under assigned plan sponsors through conducting comprehensive ...
We are looking for a Program Manager with a Public Trust that will serve as the Government’s primary point of contact for the coordination between the contractor, the Product Owner, as well as the CO and COR / ACOR single program focal point with responsibility and authority for directing and managi...
Perform quality planning, quality control activities, and quality assurance audits and reviews. Chimera Enterprises International is seeking a Quality Assurance Specialist to support the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO- CBRND) JPEO-CBRN...
ESSENTIAL DUTIES AND RESPONSIBILITIES.Works with the pharmacy manager on controlling inventories by helping track weekly sales, may order various pharmaceutical stock in order to meet customer demand and maximize profits.Weighs, measures, mixes drugs and other medical compounds and fills bottles wit...
Residential Program Manager-FLSA Status: Exempt -Hours: Full-Time. Position Summary: The Program Manager is responsible for the management of 5 licensed homes, residential supervisors, and direct care staff. Write outcomes, goals, and strategies as part of the Individual Planning process, work with ...
We are seeking a highly motivated Virtual Reality Project Manager to lead our team in the successful. Knowledge of programming and 3D modeling. ...
Position: Quality Assurance Specialist I</b></div> <div><b>Location: Frederick, MD, 21704</b> </div> <div><b>Duration: 6 Months </b> </div> <div><b>Job Type: Contract </b> </div> <div><b>Work Type: Ons...
The HR Project Manager is responsible for leading key HR Initiatives. Develop detailed project plans, timelines, and budgets, ensuring that projects are delivered on time, within scope, and within budget. Serve as the primary point of contact for project stakeholders, providing regular updates on pr...
The Assistant Project Manager is responsible for assisting the Project Manager with planning, directing, and coordinating, daily construction management activities. Reviewing project budget and timeframe with the Project Manager, and ensuring a good understanding. Knowing the status of the Project a...
The Associate General Counsel, Regulatory & Quality, will support a wide variety of FDA regulatory and quality matters related to the design, manufacture, distribution, and sale of Getinge medical devices worldwide, including product submissions, premarket activities, quality system regulations, man...
PotomacWave Consulting is seeking a Technical Writer to join our team supporting a Federal client in Frederick, MD. Responsibilities : Edits, reviews, composes, and conducts research in support of non-technical and technical products to include executive PowerPoint presentations and briefings, newsl...