Biotech Regulatory Affairs Consultant / Senior Consultant - Labeling (Contract)

Precision Life Sciences - Boston, MA

Precision Life Sciences is seeking a contract Regulatory Affairs Consultant / Senior Consultant - Labeling for our client in the life science / biotechnology industry.

As a Senior/Consultant, Regulatory Labeling, you will:

  • Collaborate with the client and their partners on an effective and efficient process for the global distribution and tracking of labeling updates for products
  • Disseminate and track approved labeling documents and supporting documentation for labeling compliance distribution and implementation requirements
  • Team with Senior Consultant and/or Labeling Strategist to:
    • Conduct international labeling operations activities to support global new product and supplemental applications from product registration, through post-approval launches for impacted international markets
    • Work with Regulatory Operations, Regulatory Affairs, Tech Ops, etc. for labeling distribution, tracking, and quality control
  • Populate and maintain labeling systems; follows FDA postings e.g., DailyMed
  • Execute quality control reviews, and track and disseminate updates to (primarily) internal labeling documents (Company Core Data Sheet (CCDS) and outward-facing local/regional labeling, as well as container and carton labels to meet regional regulatory requirements and ensure consistency between labeling and supportive documents.
  • Support SPL generation, including drug listing and establishment registration activities
  • Contribute to the continuous improvement of the end-to-end labeling process including excellent proofreading/editing skills and compiling supportive documentation
  • Support labeling inspection/audit readiness activities
  • Collaborate with the Global Labeling Team to review and monitor safety variation tracking compliance metrics for CCDS related Safety Changes
  • Prepare and review materials for recurring meetings pertaining to CCDS updates, regulatory updates, safety updates, etc.

Additionally, as a member of the Parexel Consulting team, you will be able to successfully complete the following:

Project Execution

  • Works effectively within a team environment
  • Work within broad project guidelines as directed by the project Technical Lead
  • With the guidance of the Project Technical Lead, demonstrate the ability to prioritize work to achieve specified project outcomes
  • Capitalize on opportunities to improve one’s own performance and seek feedback from the project Team Lead and colleagues
  • Apply the information provided by the project Team Lead or senior colleagues to complete assigned project activities
  • Produce quality work that meets the expectations of the project Team Lead and the client

Consulting Activities and Relationship Management

  • Follow the organization’s consulting models and methodologies under the guidance of the Project Technical Lead
  • Deliver a limited range of consulting services within the personal area of expertise under the guidance of the Project Technical Lead
  • Complete assigned activities within project scope and objectives under the direction of the Project Technical Lead
  • Identify project and internal issues to senior colleagues and Project Technical Lead
  • Interact professionally at all working levels within a client organization and within Parexel
  • Identify project and/or client needs to the Project Technical Lead

Business Development

  • Begin networking within the industry (i.e. maintain contacts and relationships with clients once engagements are complete)
  • Communicate potential new business lead to PC management and account managers

Parexel-Related Responsibilities

  • Meet established metrics as specified in the scorecard on an annual basis
  • Complete basic job-related responsibilities, including timesheets, expense reports, maintenance of CVs, project deliverable archiving, participation in internal initiatives/projects, or as a mentor as requested by management
  • Define self-development activities with the support of management to keep current within the industry

Required Competencies

  • Client Focus (Quality), Results Orientated, Interpersonal Communication, Teamwork & Collaboration, Critical Thing, and Solving Business Problems
  • At least fluent vocal and written English

Minimum Work Experience

  • Bachelor’s Degree plus at least 5 years of experience in drug development in a labeling-focused role to include a solid understanding of US labeling regulatory requirements, the requirements for tracking of labeling updates, the structure of the product labeling, the detail required to proofread labeling related documents, etc. Depending upon experience, those with a significant depth of labeling/strategy experience may be considered as Senior Consultants.

This is a home-based role; however, in the future @ 20% domestic/international travel may be required to client offices coupled with the flexibility to travel to Parexel's offices for team/client meetings

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

Posted On: Wednesday, July 20, 2022

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