PMRC Manager

Entrepreneurial Spirit, Rooted in Tradition. Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a U.S. subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC) in Japan, which touts a storied reputation more than 300 years in the making. Our parent company - one of Japan’s most respected - is a research-driven pharmaceutical company that has tirelessly pursued medical breakthroughs with global reach. MTPC has discovered and produced several first-in-class medicines for serious diseases, including multiple sclerosis (MS), diabetes mellitus (DM), and amyotrophic lateral sclerosis (ALS).

MTPA is rapidly expanding its operations across all functional areas. MTPA’s commitment to patients and their communities continues with a robust late-stage pipeline of investigational treatments for difficult-to-treat diseases and commercializing products with significant unmet medical needs in North American markets.  In the United States, MTPA launched rare diseases treatments including RADICAVA® (edaravone) injectables in 2017, EXSERVAN™ (riluzole) oral film in 2021, and RADICAVA® (edaravone) oral suspension in 2022.  The company handles research, clinical development, sales, marketing, medical affairs, and business development functions.  MTPA is dedicated to improving the treatment environment for those with debilitating diseases, researching on real-world evidence, and creating hope for all facing illness. 

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.

• 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.

• BA/BS
• Graduate Degree a plus
• 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
• Excellent attention to detail
• Proficiency in Veeva PromoMats and MS Office  

Our Value Proposition:

Enjoy the fast-moving, entrepreneurial spirit more typically found in a small biotech, complemented by the benefits of a global pharmaceutical/chemical conglomerate.  At this time, Mitsubishi Tanabe Pharma America offers our employees unparalleled opportunities for career success coupled with a supportive level of employee benefits.

MTP provides a competitive benefits package inclusive of Medical and Dental health benefits, short-term and long-term disability plans, Company Paid and Supplemental Life insurance and additional voluntary benefits such as Critical Illness Insurance, Accident Insurance, Legal Plan, and ID Theft Protection.  In addition, we provide a generous PTO policy based on tenure, commencing with 24 PTO days, pro-rated based on hire date.

The salary range for this position is $93,000 - $149,000. Factors such as scope and responsibilities of the position, candidate's work experience, education/training, job-related skills, internal peer equity, as well as market and business considerations may influence base pay offered. This salary may be subject to a geographic adjustment (according to a specific city and state and depending on the role), if an authorization is granted to work outside of the location listed in this posting.

This position is eligible to participate in our annual Short-Term Incentive (STI) program.  Specific information about the plan including eligibility rules and target, will be furnished upon hire.