Qualifications: - Providing the validation strategy for different computer systems in life sciences industry...
, or business administration. Experience in the Pharmaceuticals or Life Sciences industry (preferred). Experience consulting...
and stakeholder groups, as needed, and works to build alignment. Requirements: Bachelor's degree in life sciences or technology... management experience in a life sciences company, or the equivalent combination of education and experience. Experience in...
. Requirements: University Degree (Equivalent to Bachelor's degree) in Chemistry, Biology, Environmental Sciences, Toxicology...
as directed including but not limited to: Review and approval of key computer system Validation Life Cycle (VLC) deliverables... Development Life Cycle (SDLC) processes such as incidents, problems, changes, releases, etc.; Ensure adequate and timely...
documentation. Requirements: B.S. or equivalent in computer science, mathematics, or life science. A minimum of 5 years...
documentation. Requirements: B.S. or equivalent in computer science, mathematics, or life science. A minimum of 5 years...
management practices and conforms to departmental application development standards and systems life cycle. Incorporates source...
as needed. Support study-level audit and inspection readiness activities as needed. Requirements: Bachelor's degree in Life Science...
+ years of Med Device or Life Science Quality Management, or Quality Engineering supporting manufacturing. Some Supervisory...
development life cycle (SDLC) and experience in coding and design. Summarizes basic elements for clinical databases periodically...
Roles & Responsibilities: The ideal candidate will have 7-8 years of validation experience and at least 3 in Salesforce Validation. Seeking a CSV resource who has experience specifically with Salesforce. They are currently seeking a Sr....
Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. This is a hybrid role (in office 3 days per week) based in Marlborough, MA. ...
Responsibilities: He/she is expected to have the potential to be the analytics lead for the assigned therapeutic area (TA) to mitigate, resolve and triage certain issues and reduce the touch point needed from the study lead. Responsibili...
Responsibilities: Responsible for managing end-to-end CSV deliverables for both new & existing applications. Draft documents, QA Review of the following CSV Deliverables: User Requirements, SOPs Application Administrative Tasks & Protoco...
Responsibilities: SAS Programming: You'll utilize advanced SAS programming skills to analyse and report clinical trial data (both safety and efficacy). If applicable, develops and provides department training for applications and standa...
Responsibilities: The role requires strong US, EU, China, and international regulatory experience that can be leveraged to help support international expansion. This is a hybrid role (in office 3 days per week) based in Marlborough, MA. ...
Responsibilities: Proficient with Computerized systems on Enterprise Level, Lab Systems, and Manufacturing Systems and provide Quality oversight on the related system projects. Take Quality ownership, participate in cross functional team...
Responsibilities: Responsible to communicate new regulatory guidelines. Lead the strategic efforts in the interpretation of relevant and new quality guidelines to ensure that the current and phase appropriate requirements and standards ar...
Responsibilities: Leads all DM lifecycle activities, from study start-up, maintenance, database lock and close-out. Independently develop DM documents including but not limited to Data Management Plans (DMP), Case Report Forms (CRFs), C...