02 Nov
Regulatory Project Manager
Massachusetts, Cambridge , 02139 Cambridge USA

Vacancy expired!

job summary:As a IT Regulatory Project Manager, you will spearhead the execution of IT for regulatory projects in support of IT roadmap. In this role, you will collaborate with various stakeholders and contributors from regulatory operations, medical writing, and regulatory strategy to advance IT projects for regulatory.

Here's What You Will Do:Act as the project manager for structured content authoring (SCA) platform deployment:Identify project deliverables such as content model and taxonomy, components artifactsMonitor and manage project risks as neededFacilitate governance meetings and status updatesCoordinate activities and timelines with external vendors and IT Centers of Excellence (Cloud operations, cyber security)Lead Artificial Intelligence (AI) projects in for regulatory in collaboration with our Data Science and AI team:Collect and organize AI project artifactsWork with AI team to scope and assign the relevant project team membersLead Integration projects which entail a solid understanding of different technical workstreams and dependencies and incorporate them in overall project timelinesEstablish and manage project timelines and project deliverableWork collaboratively across the organization to gain alignment on project goals and deliverablesEngage with Computer Systems Validation team to support validation activities (as needed)Report on projects progress and status

Here's What You Will Bring to the Table:7+ years' experience in IT project management (GxP experience a plus)Proven experience with Regulatory processes and platforms (Veeva preferred).Tangible record of accomplishment in using Agile approaches in a regulated environmentAs a technologist, you know your craft and you are fluent in the IT world. You have first-hand knowledge of SaaS (Software as a Service) technology in a GxP environment and practical understanding of data integrity requirements for systems used in the conduct of clinical trials.You have a working knowledge of regulatory business processes in a drug development contextYou work independently yet engage proactively with team members, colleagues, and stakeholders to get alignment and drive projects forward.You do not hesitate to dive in and work alongside your team. You can effectively manage conflicting priorities in a fast-paced environment, and you can navigate ambiguity and lead a team effectivelyYou put team before tasks by collaborating actively with all team members and supporting them.Bachelor's degree in Computer Science, Biotechnology or equivalent required. location: Cambridge, Massachusettsjob type: Contractsalary: $85 - 95 per hourwork hours: 8am to 4pmeducation: Bachelors responsibilities:You do not hesitate to dive in and work alongside your team. You can effectively manage conflicting priorities in a fast-paced environment, and you can navigate ambiguity and lead a team effectivelyYou put team before tasks by collaborating actively with all team members and supporting them.Bachelor's degree in Computer Science, Biotechnology or equivalent required. qualifications:
  • Experience level: Experienced
  • Minimum 5 years of experience
  • Education: Bachelors
skills:
  • Project Manager
  • Project Management
  • Pharmaceutical
  • Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com. Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility). For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

    Vacancy expired!


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