Associate Manager, AH Review Comm

Description

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 several 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.

The Associate Manager, AH Review Committee is a strategic partner and the single point of contact for the Species/brand from an AH Review Committee Perspective and fully understands the integrated strategic brand plans to efficiently and effectively manage the review, approval and production of promotional and non-promotional communications. The position holder closely collaborates with the Sr. AD, core brand teams, field-based teams, extended marketing teams, Technical, Legal, and Regulatory team members as well as other internal/external partners to identify promotional and non-promotional communications that will need early alignment, review, approval, production and submission to the FDA at time of 1st use (if appropriate).

The Associate Manager, AH Review Committee ensures appropriate Species/brand prioritization based on business needs including administration and logistics. This role ensures communication of priorities to AH Review Committee. Performs editorial, tracking, and follow-up functions daily to successfully complete the AH Review Committee Process.

Duties & Responsibilities

• Based on industry knowledge and experience, act as liaison between Brand, Field Based Teams, technical, legal, regulatory, and Agencies; be responsible for negotiating solutions and resolving conflict.
• 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 all aspects (development and execution) of initial and refresher training of all AH Review Committee Process users (internal and external) to ensure successful user access set up for the AH Review Committee Process tool – Veeva Vault and to ensure understanding of and adherence to the AH Review Committee 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 and non-promotional materials.
• Spearheads monthly and ad hoc status meetings with agency and brand partners to ensure that promotional materials are created, approved and distributed in a timely manner.
• For promotional and non-promotional communications, facilitates the AH review committee process for a specific brand(s)/therapeutic area, ensuring best practices and high quality of the materials, based on solid industry/brand/therapeutic knowledge and experience.
• Ensures adherence to corporate standards of excellence, company policies, compliance and ethical business practices to be compliant with all applicable SOPs and, FDA, USDA, EPA and AFFCO regulations.
• Responsible for identifying obstacles/challenges and providing solutions with clear focus on continuous improvement of the AH Review Committee Process or promotional and non-promotional communications. This includes collaborating with Information Technology and AH Commercial Operations teams for required updates and modifications to the review tool - Veeva Vault.
• Responsible for content reviewed in system including project initiation (when applicable) and verification that the projects are ready for review in accordance with corporate, brand/Species, industry standards, departmental and SOP guidelines.
• Ensures that all permissions, references, claims, fair balance, directional statements, etc., are acceptable and accurate to BIAH guidance and SOPs.
• Recommends 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 communications.
• Ensures that all AH 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 approval for production and dissemination.
• If appropriate, ensures timely submission of materials to the AH regulatory certifier for FDA 2301 submission and ensures accuracy of promotional and non-promoti