Manager, Hp Review Committee

Strategic partner and the single point of contact for the TA/brand from a Review Committee Perspective and fully understand the integrated strategic brand plans in order to efficiently and effectively manage the review, approval and production of promotional, non-promotional, and scientific/medical communications. Closely collaborate with the Sr. AD, core brand team, field based medicine, extended marketing team, Medical, Legal, and Regulatory (MLR) team members as well as other internal/external partners to identify promotional/non-promotional/scientific communications that will need early alignment, review, approval, production and submission to the FDA at time of 1st use (if appropriate). Ensures appropriate TA/brand prioritization based on business needs across commercial and medicine including administration and logistics. Ensure communication of priority to Review Committee. On a daily basis, perform editorial, tracking, and follow-up functions to successfully complete the Review Committee Process. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies´ success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim´s high regard for our employees.

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

Duties & Responsibilities

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.

Requirements

• 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 Marketing and/or Medical Operations that can be applied to a wide range of standard and non-standard situations, interprets client and business needs, assesses requirements/options and identifies solutions to non-standard requests. Resolves day-to-day or routine problems using defined processes; takes a new perspective on existing solutions, Coordinates resources and sets priorities to meet short term objectives and deadlines within department.

Desired Skills, Experience and Abilities

• Demonstrated ability to manage large projects, multi-task and achieve desired results, especially under pressure.
• In depth knowledge and experience with FDA/DDMAC regulations.