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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-promotional materials “Date of First Use”.

+ Manages and coordinates with promotional material storage and fulfillment vendor to ensure they receive necessary information to allow dissemination of approved pieces to Marketing and Field based teams.

+ Leads and collaborates with Marketing, Technical, Regulatory, Legal and Agencies to create 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 required.

+ In lieu of a degree, ten (10) years of progressive experience around Pharmaceutical Review Committee of Promotional or Scientific Communications required.

+ Four (4) years’ experience in a Pharmaceutical Marketing, Veterinary Medicine, Sales, Editorial, or Agency organization, with a solid understanding of the Technical, Legal and Regulatory requirements for promotional and non-promotional materials required.

+ 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.

**Eligibility Requirements** :

+ Must be legally authorized to work in the United States without restriction.

+ Must be willing to take a drug test and post-offer physical (if required).

+ Must be 18 years of age or older.

Desired Skills, Experience and Abilities

All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.