Manager, HP Review Committee

Overview

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This role is based on-site at our Ridgefield, CT location with hybrid flexibility of 2-3 days per week on-site.

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This position offers a base salary typically between $90,000 and $147,000. The position may be eligible for a role specific variable or performance based bonus, relocation and or other compensation elements.

• Based on industry knowledge and experience, act as liaison between Brand, Field Based Medicine, medical, legal, regulatory, and Agencies; be responsible for negotiating solutions and resolving conflict. Also responsible for proactively recommending solutions that adhere to industry regulations, laws, policies, SOPs, etc. Responsible for probing for information to clarify issues and improve process
• Responsible for working with, and assisting with management of, Agency partners to align on timelines and to ensure transparent communications to all those working on the creation/review/approval of promotional materials. Spearhead weekly status meetings with agency and brand partners to ensure that promotional materials are created, approved and distributed in a timely manner
• For promotional, non-promotional, and scientific/medical communications, facilitate the review committee process for a specific brand(s)/therapeutic area, ensuring best practices and high quality of the materials, based on solid industry/therapeutic knowledge and experience
• Ensure adherence to corporate standards of excellence, company policies, compliance and ethical business practices to be compliant with all applicable SOPs and FDA regulations
• Responsible for identifying obstacles/challenges and providing solutions with clear focus on continuous improvement of the Review Committee Process or promotional, non-promotional, and scientific/medical communications
• Responsible for content reviewed in system including project initiation and verification that the projects are ready for review in accordance with corporate, brand/TA, industry standards, departmental and SOP guidelines. Ensure that all permissions, references, claims, fair balance, directional statements, etc, are acceptable and accurate to BIPI guidance and SOP. Recommend review pathway for all pieces, and judge which pieces should be reviewed on-line and which should be discussed, based on issues, in meetings.
  
  Also, what review pathway is appropriate for promotional vs. non-promotional vs/ scientific/medical communications
• Ensure that all Review Committee comments are captured and sent to the Content Owner/Agency and ensure that all required changes are made. Responsible for quality assurance of materials prior to review and proofs prior to printing/electronically publishing. If appropriate, ensures timely submission of materials to DRA for FDA 2253 submission and ensures accuracy of promotional materials “Date of First Use”
• Establish and maintain the brand library (for example, claims, copies of approved promotional pieces, fair balance, clinical references, logos, etc.) Facilitates concept reviews and disseminating their outcomes

• Bachelor´s degree from an accredited institution required
• If the candidate does not have a bachelor´s degree, then ten (10) years of progressive experience is required in the area of Pharmaceutical Review Committee of Promotional or Scientific Communications
• Four (4) years´ experience in a Pharmaceutical Marketing, Medicine, Sales, Editorial, or Agency organization, with a solid understanding of the Medical, Legal, & DRA review of promotional or non-promotional/scientific materials required
• Project management experience
• Demonstrated strong communication, organizational, time management, ability to facilitate, attention to detail, and process/systems skills required
• Demonstrated relationship management, influencing abilities, ability in conflict management and negotiation required
• History of successful performance through fast and focused execution, strategic thinking, and ability to foster a collaborative environment
• Depth of knowledge in…