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Project Associate (Regulatory Sciences)

Company: Voisin Consulting Life Sciences (VCLS)
Location: Cambridge
Posted on: June 22, 2022

Job Description:

Working at VCLS is more than just a job, we offer a career. VCLS welcomes junior and senior-level professionals alike, and joining the team means striving for excellence and true understanding of both the regulatory environment we evolve in and how this environment may affect the needs of our clients. If the promise of delivering effective therapies and making them accessible to patients excites you, consider applying for this opportunity.
About the Opportunity: In this junior-level Project Associate role for Regulatory Sciences project teams, responsibilities include:
(1) Project Management: As a project team member, support the prescribed activities for client projects, adhering to strategy, timelines, and milestones:

  • Project coordination and keeping track of timelines/deliverables using project management tools
  • Timely internal and external communications and updates
  • Organize and participate in project opening meetings
  • Update team member assignments and allocated time in the resource management system
  • Coordinate, organize, and participate in project team meetings, including Regulatory Agencies meetings/preparations
  • Organize travel plans and agendas for team members
  • Participate in project reviews
  • Archive project data in the knowledge management system at project closing
  • Consistently achieve billability targets
    (2) Support the preparation of Regulatory Sciences project deliverables:
    • Format document references including: abbreviation tables, automatic headings, table and figure captions, and cross-references
    • Create and bookmark PDFs
    • Prepare project deliverables for submission including: printing, binding, final QC, shipping, and tracking

      The ideal candidate will possess the following qualifications:
      • Knowledge of Project Support and Regulatory Operations/Sciences as demonstrated through a combination of work experience and/or academic background
      • Project coordination/management experience
      • Prior experience in pharma, biotech, or related life sciences industry preferred
      • Experience in a consulting environment is a plus
      • BS/BA in Regulatory Affairs or Life Sciences is a plus
        Personal attributes and skills
        • Strong attention-to-detail, organization/multitasking, teamwork, and communication (written and verbal) skills
        • Project management (planning, scheduling, documentation)
        • Problem-solving abilities and a self-starter
        • Computer skills including Windows, MS Office (Outlook, Word, Excel, PowerPoint, SharePoint), and Adobe Acrobat
        • Ability to work remote, but local to work in the Cambridge office
        • Professional and courteous work demeanor; a team player and relationship builder
        • Ability to work under deadlines to meet timelines, including the ability to modify work schedule when needed
        • Maintains company values (People, Innovation, Passion, Excellence) and demands the highest standards of conduct from self and others Additional Information
          • Equal Opportunity Employer
          • All resumes are held in confidence
          • Must be eligible to work in the US
            About the CompanyVoisin Consulting Life Sciences (VCLS) is a team of 200+ life sciences professionals specialized in consulting services to innovative life sciences companies: biotechnology, healthtech, and pharmaceutical companies. VCLS supports its clients throughout product development from the design of global development plans and regulatory strategies to their implementation and submissions to regulatory agencies and payers. Its expertise encompasses the full spectrum of health products: drugs, biologics, cell and tissue therapies, medical devices/ digital, In-Vitro Diagnostics/CDx, combination products, as well as nutraceuticals and cosmeceuticals.
            With team members based across Europe (London, UK; Paris & Rennes, France; Lausanne, Switzerland, Copenhagen, Denmark), the USA (Cambridge, MA and Somerville, NJ), and Asia (China and India (Bangalore)), VCLS is constantly searching for talented people attracted by innovation, geographical and cultural diversity of the organization and its clients, and by the very rewarding and stimulating career opportunities offered to the employees.

Keywords: Voisin Consulting Life Sciences (VCLS), Cambridge , Project Associate (Regulatory Sciences), Other , Cambridge, Massachusetts

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