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FPR Lead

Remote: 
Full Remote
Experience: 
Senior (5-10 years)
Work from: 

Indegene logo
Indegene
5001 - 10000 Employees
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Job description

Final Publication Review (FPR) Lead (Must be available to work Pacific Time Zone hours)


Responsibilities and key activities include but are not limited to:


Publication Process Support

  • Processing incoming Final Publication Review (FPR) requests
  • Performing quality checks to ensure data accuracy
  • Coordinating timely approvals of existing FPR requests
  • Maintaining publications databases and records within Salesforce
  • Assisting stakeholders by troubleshooting submission and technical issues
  • Following up on unanswered automated requests for reviews and approvals
  • Uploading final versions and metadata to publication archive
  • Maintaining an up-to-date knowledge of SOP, best practices, product team dynamics, and other outlined processes
  • Escalating compliance issues and exceptions as identified
  • Assisting with Publication Coordinator responsibilities, as needed


Leadership

  • Owning and managing guidance documents related to the FPR process
  • Training new employees on FPR processes and managing stakeholder relationships
  • Ensuring compliance and adherence to SOP, including timely communication of updates to FPR stakeholders
  • Presenting updates and key metrics in regular review meetings


Basic Qualifications:

Bachelor's degree (life sciences or related field preferred) and 1 year of medical publications, Salesforce, project management, or editorial experience

OR

Associate’s degree and 3 years of medical publications, Salesforce, project management, or editorial experience

OR

High school diploma or GED and 5 years of medical publications, Salesforce, project management, or editorial experience


Preferred Qualifications:

  • Experience working with strict compliance requirements and processes
  • Discretion in dealing with proprietary company information
  • Salesforce experience a must, including a working knowledge of Salesforce reporting tools
  • Proficiency with MS Office (specifically Outlook, Word, and Excel)
  • Excellent computer skills with strong emphasis on data entry and process adherence
  • Experience with project management tools, methodologies, and practices
  • Strong organizational, oral/written communication, and presentation skills
  • Ability to foster collaboration, work effectively on cross-functional teams, and consistently meet deadlines
  • Proven ability to thrive in a dynamic matrix environment
  • Self-starter, flexible, and enjoys helping others
  • Experience in the pharmaceutical, biotechnology, or other healthcare-related field preferred but not required


Required profile

Experience

Level of experience: Senior (5-10 years)
Spoken language(s):
English
Check out the description to know which languages are mandatory.

Other Skills

  • Quality Assurance
  • Microsoft Office
  • Organizational Skills
  • Teamwork
  • Communication

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