Roles & Responsibilities: 8 yrs of experience on clinical trial data analysis using SAS. Preferably in UNIX environment Familiar with UNIX command and environment. Deep knowledge on CDISC Standards and solid ADaM programming experience. ...
Responsibilities: Support the planning, setup, and acquisition of external clinical data at the study level, assisting in managing study start-up, conduct, and closeout activities. Assist in creating external data transfer agreements, en...
Roles & Responsibilities: Bachelor / master's degree in electrical engineering preferred. 6+ years of engineering experience. Strong Organizational and communication skills. Proficient problem-solving skills. Strong Interpersonal...
Responsibilities: Drive process validation activities to ensure compliance with medical device regulations. Design and develop equipment and tooling to support production needs. Provide hands-on production support to address and resol...
of project and life-cycle reports and review/approve all other documents to ensure compliance with SOP. Ensuring...
Roles & Responsibilities: 8 yrs of experience on clinical trial data analysis using SAS. Preferably in UNIX environment Familiar with UNIX command and environment. Deep knowledge on CDISC Standards and solid ADaM programming experience. ...
Responsibilities: Must Have MDR experience. IVD (In-vitro Diagnostics) is highly preferred. Support the IVDR project by revising the assigned technical files. Each technical file must be generated using the latest technical file template...
Responsibilities: Participate in the development of the CMC regulatory strategy for small molecules. These submissions include health authority briefing packages, IND/CTA, NDA, and MAA regulatory filings. Prepare and review CMC submissi...
Responsibilities: Providing quality assurance support and oversight for System Development Life Cycle (SDLC...) an average of 4 days/week; dependent on operations. Requirements: B.S. and/or M.S. degree in an appropriate Life Science, Computer...
and responsibilities, on occasion, as assigned. Requirements: Bachelor's Degree in Scientific discipline e.g. Chemistry, life Sciences...