Manager Regulatory Review

2 weeks ago

Philadelphia, United States Digitas Health Full time

Job Description

The Manager, Regulatory Review manages a team of Associates and Senior Associates to ensure marketing materials for a client (or group of clients) follow the protocol established by our pharmaceutical clients for regulatory review. You will contribute in establishing procedures for our teams and advising on specific projects to aid smooth and fast review by clients. You will report to the Director, Regulatory Promotional Operations.

This is a hybrid role, requiring three days in-office each week. If you are contacted for an interview, your recruiter will discuss specifics with you, inclusive of any necessary reasonable accommodations.

Your Impact:

  • Manage multiple direct reports at the Associate, Senior Associate, and Manager level including responsibility for interviewing, hiring, onboarding, and career development
  • Provide estimates for SOW development
  • Work with the Director, Regulatory Review in the development of departmental SOPs
  • Oversee work of reporting employees on daily basis, providing advice on projects, and addressing problems as they arise
  • Coordinate work among reporting staff to manage workflow and ensure appropriate coverage for all client needs including vacation coverage
  • Determine the time and effort required to complete each submission
  • Establish a timeline and assign responsibility to the appropriate team members for delivering the components of the submission
  • Oversee the creation of the components and ensure they conform to client and Digitas Health guidelines
  • Maintain a comprehensive, accurate dashboard of all current and upcoming submissions including the stage of review, job codes, and deadlines
  • Follow up with client liaison promptly to ensure the submission is received on time and meet 100% of client expectations and specifications
  • Maintain to the department procedure(s) specific to the clients supported

Qualifications:
Qualifications

  • Minimum of a bachelor's degree
  • 4+ years of experience preparing complex deliverables under tight deadline constraints is required
  • Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous experience
  • At least one year of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency is required

Additional Information

Our Publicis Groupe motto "Viva La Différence" means we're better together, and we believe that our differences make us stronger. It means we honor and celebrate all identities, across all facets of intersectionality, and it underpins all that we do as an organization. We are focused on fostering belonging and creating equitable & inclusive experiences for all talent.

Publicis Groupe provides robust and inclusive benefit programs and policies to support the evolving and diverse needs of our talent and enable every person to grow and thrive. Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off.

If you require accommodation or assistance with the application or onboarding process specifically, please contact hrcompliance_usms@publicis.com.

All your information will be kept confidential according to EEO guidelines.

#LI-Hybrid

Qualifications * Minimum of a bachelor's degree * 4+ years of experience preparing complex deliverables under tight deadline constraints is required * Demonstrated knowledge of FDA pharmaceutical advertising regulations through appropriate training or previous experience * At least one year of experience in Pharmaceutical Industry, Healthcare, or Advertising Agency is required Additional Information Our Publicis Groupe motto "Viva La Différence" means we're better together, and we believe that our differences make us stronger. It means we honor and celebrate all identities, across all facets of intersectionality, and it underpins all that we do as an organization. We are focused on fostering belonging and creating equitable & inclusive experiences for all talent. Publicis Groupe provides robust and inclusive benefit programs and policies to support the evolving and diverse needs of our talent and enable every person to grow and thrive. Our benefits package includes medical coverage, dental, vision, disability, 401K, as well as parental and family care leave, family forming assistance, tuition reimbursement, and flexible time off. If you require accommodation or assistance with the application or onboarding process specifically, please contact [hrcompliance_usms@publicis.com](mailto:hrcompliance_usms@publicis.com). All your information will be kept confidential according to EEO guidelines. \#LI-Hybrid #J-18808-Ljbffr

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