Responsibilities: The Regulatory Manager (RM) provides regulatory strategy and development guidance for optimal conduct of clinical trials, regulatory agency meetings, orphan designations, paediatric planning, and accelerated procedures, ...
Job description: The Biologics CMC Developability (BCD) group sits at the interface of discovery and development. The core role of BCD is to deliver meaningful and actionable data to support the selection of candidate molecules to progress...
Roles & Responsibilities: Serve as the subject matter expert for planning, setup, and acquisition of external clinical data at the study level, managing study startup, conduct, and closeout activities. Create external data transfer agree...
Roles & Responsibilities: Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Client procedures and guidelines, the duties and responsibilities for this position are: I d...
Responsibilities: Provide leadership, strategic planning, direction and implementation of clinical systems for data collection which may include vendor selection, budgeting, resource planning, vendor oversight, EDC build and study timelin...
Job Description: Responsibility for the Quality and Compliance of process development and manufacturing of implantable ( Class III) Cardiac and Neuromodulation medical device related products. Initial scope of work may be focused on Inspec...
Roles & Responsibilities: Plan, lead, and execute the validation efforts for SCADA, Rockwell Factory Talk, PLC's and Ignition Talk Create/write validation documentation (VP/URS/FS/DS/Trace Matrix/Risk Assessment/IQ/OQ/PQ, etc.) for proce...
Summary: This role involves solid, hands-on CSV work in a regulated environment where good documentation, accountability, and clear communication are essential. Responsibilities: Evaluating, coordinating, and executing efforts to suppo...
Roles and Responsibilities: Strong technical writing and documentation skills. Ability to gather requirements and inputs from SMEs and project teams. Experience in Life Sciences / Pharma / Biotech. Experience as a Test Lead (Manual & A...
Job description: Collects environmental and utility samples for microbiological and chemical testing. Performs microbiological testing on water and swabs. Responsibilities: Implements, maintains, and makes changes to create global solu...