Sr. Manager HPRC and NTA Effectiveness

Compensation Data

This position offers a base salary typically between $111,000.00 and $183,000.00. The position may be eligible for a role specific variable or performance based bonus and or other compensation elements. For an overview of our benefits please click here.

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, diversity and inclusion, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Senior Manager, HPRC and NTA Effectiveness is a proactive strategic partner and the single point of contact for the TA/brand from a HPRC (Human Pharma Review Committee) and NTA (Non-Trial Activity) perspective and fully understands the integrated strategic brand plans to efficiently and effectively manage the HPRC review, approval, and production of promotional, non-promotional, and scientific/medical communications. This role closely collaborates with the Director, HPRC & GTM Content Lead, core brand team, field-based medicine, extended marketing team, Medical, Legal, and Regulatory (MLR) reviewers, and 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 as appropriate. The incumbent ensures appropriate TA/brand prioritization based on business needs across commercial and medicine including administration and logistics and ensures such prioritization is communicated to the Review Committee.

The SR Manager, HPRC and NTA Effectiveness performs editorial, tracking, and follow-up functions to successfully manage and complete the Review Committee Process daily. Additionally, this role ensures the appropriate, effective, and compliant management of local U.S. Non-Trial Activities (NTA). This individual will closely collaborate with the Associate Director, Non-Trial Activity Capability Enablement and serve as a key point of contact for the global NTA governance team as well as local colleagues for all NTA processes.

The SR Manager, HPRC and NTA Effectiveness will be accountable for adhering to all NTA governance requirements to ensure Boehringer NTA activities and system records remain compliant and, in an audit-ready state, including FDA inspections. This individual will be accountable for executing/fulfilling any internal and external audit requests, including being called upon as an SME interviewee during such audits.

• 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, acts as proactive strategic partner between Brand, Field Based Medicine, Medical, 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 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.
• Spearheads 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, facilitates the HPRC 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.
• Ensures 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 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.
• Ensures that all permissions, references, claims, fair balance, directional statements, etc., are acceptable and accurate to BIPI guidance and SOP. Recommend appropriate review pathway for all piece types (promotional, non-promotional and scientific/medical communications), and judge which pieces should be reviewed on-line, and which should be discussed, based on issues, in meetings.
• 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”.
• Creates, monitors, trains to and maintains HPRC and NTA process and associated HPRC and NTA systems training for all HPRC and NTA internal and external stakeholders in collaboration with other key stakeholders.
• Establishes and maintains the brand library (for example, auto-claims, copies of key, foundational approved promotional pieces, fair balance claims, clinical references, logos, etc.).
• Facilitates concept reviews and helps to mediate discussions relevant to risk, disseminating their outcomes utilizing careful communication.
• Leads local Non-Trial Activity (NTA) review and approval process and ensure process compliance according to global SOP for assigned TA’s.
• Leads and actively participates in the classification, review, and approval of NTA projects.
• Consults business NTA project owners, provides guidance and shares expertise on best practice ways of working in close collaboration with global governance team.
• Drives NTA process flow and consultation with Medicine, PV and other functions as required.
• Ensures and facilitates appropriate local NTA process trainings.
• Tracks process performance according to defined metrics (KPIs) and implements process improvements to enhance the overall effectiveness of the HPRC and NTA Process.

Requirements

• Bachelor’s degree required.
• In lieu of a degree, ten (10) years of progressive experience is required around Pharmaceutical Review Committee of Promotional or Scientific Communications.
• Three to five (3-5) 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.
• Demonstrated strong project management, communication, organizational, time management, facilitation, attention to detail, and process/systems skills required.
• In depth knowledge and experience with FDA/DDMAC regulations and solid Pharmacovigilance knowledge required.
• Demonstrated relationship management, influencing abilities, ability in conflict management and negotiation required.
• Understanding of operations process, lean six sigma and pharmacovigilance/AE reporting a plus.
• History of successful performance through fast and focused execution of competing priorities, strategic thinking, and an 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.