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Design and implement the functional Medical Affairs strategy plan, oversee IIS and expanded access programs, lead publication strategy, lead the writing of selected publications and Grant applications. Oversee the Strategy plan and implementation of scientifically sound Investigator Initiated Studies, manage publication planning and execution to ensure that all data gener
Posted 2 days ago
The Manager, Data Management is responsible for managing all aspects of data management activities and assigned direct reports to ensure all time frames and targets are met. The Manager, Data Management may serve as portfolio level oversight or as Biometrics Project Manager for data management and biostatistics stand alone programs. Responsibilities Onboarding of new empl
Posted 3 days ago
The Vice President, Business Development, is accountable for leading daily performance management and the results of the business development staff assigned. Through daily coaching and training, in addition to leading enterprise level accounts and business opportunities, this role drives sales outcomes as well as the development of existing staff. The Vice President, Busi
Posted 1 day ago
Develops scientific understanding of assigned program and protocol requirements Supports protocol design and development strategy for clinical trials Manages protocol development process; including writing support, reviewing, adjudication/resolution of cross functional comments, and ensuring high quality final document Contributes to the development of Informed Consent Fo
Posted 3 days ago
OVERVIEW We are currently searching for a skilled professional to join a well known client's team as an Occupational Health Nurse in Plymouth, MN. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES Provide occupational health services including treatment and care to site pop
Posted 4 days ago
Develop a robust timeline and plan for the overall program. Development or improvement of program processes to drive program efficiency Update program trackers and program update reports Assist with PMO deliverables for program health improvement initiative Take on project management remediation process which includes coordinating with program workstream leaders to manage
Posted 5 days ago
OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Medical Technical Writer, Remote. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES Manages and writes/edits relevant sections of global clinical documents, required for a
Posted 9 days ago
Independently perform the following responsibilities under the direction of the Product Development Manager and/or Program Head to coordinate, manage, and lead the overall execution of clinical studies or group of clinical studies while following appropriate GCPs and SOPs Provide scientific insight into study design and disease process; Lead protocol development and writi
Posted 10 days ago
Serves as the Regulatory Affairs lead on cross functional MDR project teams Ensures compliance with EU Medical Device Regulations (MDR) and EU guidance throughout the project. Actively participates in EU MDR project teams by attending meetings, collaborating with the project manager and cross functional team members, and communicating regulatory requirements and guidance
Posted 10 days ago
OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Clinical Trial Assistant in South Portland, ME. The Clinical Trial Assistant role will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES To provide general administrative support to the M
Posted 10 days ago
OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a QC Technician III in Saint Joseph, MO. Their work will have a direct impact on the organization and the larger clinical industry, making this an amazing career opportunity. RESPONSIBILITIES Performs bio analytical methods (Chemistry lab) for various Bio QC Tests on raw ma
Posted 10 days ago
Executes fundamental unit operations in Downstream manufacturing related to the manufacturing of bulk drug substance in a multi product facility. Performs duties under limited supervision and according to standard operating and manufacturing procedures. Executes independently with adequate training non complex fundamental operations as parts cleaning, weigh and dispense,
Posted 10 days ago
OVERVIEW We are currently searching for a skilled professional to join a well known client's team as a Medical Safety Reviewer in Columbus, Ohio. The Medical Safety Reviewer role will support the medical safety team by collecting, assessing, processing adverse events for clinical or post marketed products in compliance with applicable regulations, guidelines, researching,
Posted 12 days ago
The Senior Director, Business Development, effectively identifies and pursues new and existing business opportunities while enhancing relationships with existing clients, keeps abreast of industry trends, competitors' services and acquisitions, and works in conjunction with leadership to develop and respond to new and existing business development opportunities. The Senio
Posted 1 day ago
Responsible for the management of assigned clinical trial(s) and the physician training events by leading cross functional teams that may include tasks specific to study start up, regulatory, contract and budgeting, safety, medical monitoring, training event planning, etc. Serves as the clinical trial/project point of contact and the liaison with the CRO, third party vend
Posted 5 days ago
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