Promotional Review Committee Manager

Company: Planet Pharma
Location: Bloomington
Posted on: November 22, 2021

Job Description:

6 month Extendable CONTRACT
100% Remote -This role will be focused on Germany-Need a candidate who is willing to work early morning hours while dealing with teams over in Europe
MUST HAVES:-Must be fully vaccinated-Need a candidate who has the ability to own PRC submissions-Need to have material review experience in pharma
Position Summary: The Manager, EMEAC PRC plays a critical role in leading the Promotional Review Committee process and oversight of the effective review and approval of promotion materials to meet business objectives. It is a highly engaging role working across multiple disciplines where you will drive the process, systems and resources in a streamlined manner and support the launch of the client internationally. Responsibilities:

• Lead the medical and regulatory review process for EMEAC marketing. Lead the Promotional Review Committee review process of materials or information intended to be made available to health care professionals, patients, consumers, payers, or other customers, which make reference to an approved or investigational product. Also, for non-branded materials intended for external audiences such as disease awareness.
• Work across stakeholders in EMEAC region countries as well as consulting with US PRC when necessary for the successful execution of responsibilities.
• Evaluates and works with EMEAC marketing and other teams to project future material volume and associated resource needs of the PRC teams. Seeks to build and maintain collaborative relationships with all involved in the PRC process and sets a model for professional and productive interactions.
• Regularly updates with infused medicines business units and international marketing leaders to understand any current challenges and to stay current on business priorities.
• Leads the EMEAC PRC, review team and weekly tracking meetings to coordinate all relevant activities of the Promotional Review Committee which includes interaction with stakeholders (includes, but is not limited to, project owner, Medical, Regulatory, Legal, Regulatory Operations, etc.).
• Leverages and aligns on opportunities across regions (including the US) to consistently adopt best practices and lessons learned and utilize insights to drive a more holistic approach across these businesses.
• Leads the escalation forum with senior leaders for materials as needed and ensures that all elevation activities for PRC review are resolved in a timely manner, includes all relevant stakeholders and is documented appropriately.
• Partners with cross-region partners (including US) to drive continuous improvements in the process and update the international PRC process and addendums to PRC SOPs so that international review and approvals are in line with affiliate and regional regulations.
• Accountable as system owner for Veeva PromoMats for EMEAC. Regularly evaluates business needs to ensure that we seek to streamline, automate and implement new modules and changes to drive business efficiencies.
• Develops and leads forums with cross-functional stakeholders to share important information relevant to PRC and others related to international launches.
• Responsible for the technical process of pushing (uploading) EMEAC digital content (i.e., IVAs, emails) from Veeva PromoMats to EMEAC Veeva CRM successfully including troubleshooting and working with IT, agencies, marketing and others as needed.
• Responsible for partnering with Regulatory, Legal (and Compliance where necessary) to evaluate country-specific guidelines and regulations and revising PRC process and PromoMats to meet these needs. Responsible for training reviews, project owners, agencies and others within county and region to facilitate the PRC process. Qualifications and Skills Required:
  • Bachelor's degree required (or 6 years' equivalent Pharmaceutical industry experience in medical/regulatory review)
  • Strong knowledge and understanding of EMEAC country regulations in terms of ad/promo development.
  • Flexibility in working across both European and North American time zones as needed.
  • Ability to drive change and a positive culture while continually aligning with business objectives
  • Ability to build and maintain strong collaborative relationships with leaders across the organization
  • Proficient in Microsoft Office
  • Strong analytic skills
  • Professional, proactive demeanor .
  • Excellent written and verbal communication skills.

Keywords: Planet Pharma, Bloomington , Promotional Review Committee Manager, Executive , Bloomington, Illinois