Promotional Materials Review Committee Manager

Shionogi•Florham Park, NJ

17h•Hybrid

About The Position

The Promotional Materials Review Committee (PMRC) Manager is responsible for committee review activities in support of external commercial and corporate communications. The incumbent will provide committee review requirements to corporate and commercial functional project managers and external vendors generating promotional pieces while leading a cross-functional PMRC that assesses risks of promotional materials including patient, health care provider (HCP), disease state educational, sales training and press materials as well as other external communications. Within the PMRC, the incumbent will provide governance and scheduling of committee activities for developing promotional draft labeling for regulatory authority review (i.e., OPDP), and after approval, for maintaining documents.

Requirements

BA/BS
Minimum of 5-7 years of experience in the pharmaceutical industry which provided a fundamental understanding of OPDP requirements, involvement in commercial activities, and specific experience with promotional review duties
Proven ability to effectively manage interactions with internal departments and externally
Ability to interact with cross-functional teams in a matrix organization
Cross-border project management experience
Well-organized self-starter, hard-working and independent
Strong negotiation, verbal/written communication and interpersonal skills with a good awareness of global cultural differences
Maintains optimism and energy in the face of change and adversity; willing to collaborate and problem solve.
Excellent attention to detail
Proficiency in Veeva PromoMats and MS Office

Nice To Haves

Graduate Degree a plus

Responsibilities

Supports promotional and Corporate communications PMRC review activities and overall function and coordination/scheduling of committee meetings.
Manages the overall PMRC process as outlined in the PMRC SOP to ensure effective collaboration and to ensure that each internal function and external agency represented on the PMRC is achieving its intended role/goals; acclimates newly appointed team members in compliance with PMRC guidelines/processes/practices.
Effectively interacts with external agencies about related marketing and promotional pieces both new and revised.
Schedules PMRC meetings with accompanying agendas and material to be reviewed.
Confirms and leads the PMRC meetings: displays the materials to be reviewed, enters changes/comments as needed, responds to outstanding comments after discussion and secures digital sign-offs from all PMRC reviewers.
Manages movement of materials through each stage and PMRC approval process.
Reviews final production proofs provided by Commercial, conducts some functional reviews (e.g. websites, videos, etc) and if deemed acceptable, approves for submission to FDA Office of Prescription Drug Promotion (OPDP), as required.
Works closely with Regulatory Affairs department, ensuring timely submission of materials to OPDP.
Provides support for proposed changes to systems, procedures, methods pertaining to promotional materials.
Schedules Senior PMRC meetings as needed to address complex topics that cannot be agreed to at PMRC.
Ensures editorial accuracy of each item.
Contributes to organizational effectiveness initiatives, decision-making, planning, and project management; also, continually benchmarks against other companies and initiates “best practices” in relation to teams and to PMRCs specifically, to ensure that the PMRC is working at maximum efficiency.
Incorporates all approved changes/comments to promotional materials.
Ensures version control and maintains records of approved promotional pieces for field use and dissemination.
Working with the PM Regulatory representative, tracks all electronically submitted promotional pieces submitted by the Regulatory Operations to OPDP.
Leads the review process using the Veeva PromoMats system; stays abreast of software updates and new functionality and relays information to other team members.