Manager, HP Review Committee

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.

The Manager, HP Review Committee is a 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 Director, 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, 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.

• 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…