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  • ID
    #46894347
  • Job type
    Contract
  • Salary
    USD85 - USD95
  • Source
    Randstad Technologies
  • Date
    2022-11-02
  • Deadline
    2022-12-31
 
Contract

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 artifacts

Monitor and manage project risks as needed

Facilitate governance meetings and status updates

Coordinate 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 artifacts

Work with AI team to scope and assign the relevant project team members

Lead Integration projects which entail a solid understanding of different technical workstreams and dependencies and incorporate them in overall project timelines

Establish and manage project timelines and project deliverable

Work collaboratively across the organization to gain alignment on project goals and deliverables

Engage 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 environment

As 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 context

You 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 effectively

You 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, Massachusetts

job type: Contract

salary: $85 - 95 per hour

work hours: 8am to 4pm

education: 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 effectively

You 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.

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