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Job Details

Regulatory Affairs Manager – AdPromo

Company: RBW Consulting
Location: Cambridge, MA
Reference: raa-ramap-cma
Closing Date: 20 Mar 18
Type: Full Time
Salary (£): 100,000+
Benefits: Competitive Benefits Package

Job Summary:

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Requirements:

Regulatory Affairs Manager – AdPromo

Cambridge, MA

Summary:

Our client is looking for an experienced regulatory professional.  The Regulatory Advertising & Promotions Manager will play a key role in managing the advertising and promotions material for the company’s commercial products. The Ad/Promo Manager is responsible and accountable for the Medical, Legal and Regulatory (MLR) process. 

Responsibilities:

  • Accountable for the MLR process (project manager of the process); manage MRL compliance
  • Create and issue MLR meeting agendas and coordinate activity around MLR meetings, including scheduling
  • Coordinate with Marketing and Medical on the item prioritization
  • Confirm materials are complete and ready for MLR review (within the Veeva Vault PromoMats system)
  • Assist in management of Veeva Vault PromoMats System; track materials through the Veeva Vault PromoMats system
  • Ensure the MLR meeting is progressing according to the agenda and allotted timeframe
  • Act as note-keeper during all MLR meetings, including escalation meetings, as needed
  • Collect and report metrics on the MLR team
  • Manage the resolution of MLR review comments, including escalation meeting comments, as needed
  • Ensure materials are tracked according to final MLR disposition
  • Develop and maintain the standard language document and standard reference binders
  • Coordination with regulatory submissions for 2253 material submission
  • Provide training to new MLR participants

Requirements

  • BS/BA degree and/or equivalent experience
  • 4 years experience in regulatory affairs in the pharmaceutical/biotech industry
  • Solid understanding of the processes and interactions essential for the production and submission of regulatory submissions
  • Experience with US promotional regulatory submissions
  • Expertise in Word, PowerPoint, Adobe
  • Experience working with Veeva Vault PromoMats preferred but not required
  • Must be “hands-on” and willing and expected to take on projects and tasks to support the team
  • Able to implement and manage multiple projects simultaneously
  • Demonstrates excellent teamwork and communication skills with an ability to impact and influence the decisions of a team
  • Attention to detail and highly organized

I manage a range of other permanent and freelance positions for a broad portfolio of clients, so if the above role isn’t for you but you’d nevertheless like to discuss other opportunities currently available both now and in the near future, we are happy to get in touch at your discretion. Contact Ross Apted at 617 982 1238 today!

Apply for this job: Regulatory Affairs Manager – AdPromo

Contact Information:

Address:  US Team
210 Broadway #201, Cambridge, Massachusetts,
02139
USA
Tel:  (617) 982 1238
Website:  Visit Our Web Site

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