Description

The Regulatory Affairs Fellow - Advertising and Promotion is a post-doctoral pharmacist position that will obtain broad exposure to BI US Medical functions including, but not limited to -- Medical Affairs and Scientific Communications, clinical operations, translational medicine and clinical pharmacology, and regulatory affairs. This position will require the Fellow to develop competencies necessary to contribute to their respective functional area within a pharmaceutical company. The Fellow will be based at Boehringer Ingelheim's U.S. headquarters in Ridgefield, CT, working on a particular or multiple therapeutic areas (TAs) in the areas of cardiology, diabetes, immunology, oncology, and respiratory. Through a series of rotations either within or outside of the assigned area, the Fellow will also gain an understanding of the broad range of opportunities available to a pharmacist in the pharmaceutical industry. 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.

The Fellow will serve as the Regulatory Affairs representative on the Human Pharma Review Committee (HPRC) team, working cross-functionally with Medical, Legal and Marketing stakeholders. As a member of the HPRC team, the Fellow will build a foundational understanding of compliance with the Food Drug and Cosmetic Act (FDCA), FDA Guidance, and the current Regulatory landscape. The Fellow will review promotional claims and materials for Boehringer Ingelheim prescription drugs for compliance with FDCA and for consistency with product labeling. The Fellow will review scientific exchange communications, disease awareness campaigns, and other unbranded materials that require HPRC approval. The Fellow will actively contribute in HPRC, providing regulatory guidance on promotional communications and risk mitigation strategies across therapeutic areas. Upon completion of the fellowship, the Fellow will become proficient in Regulatory Affairs Advertising and Promotion Compliance through hands-on training and responsibilities across therapeutic areas.

Duties & Responsibilities

Under the guidance and leadership of your mentor, you will:

• Review and approval of promotional communications for consistency with product labeling and regulations related to prescription drug promotion.
• Knowledge and understanding of drug development, including phases of clinical studies, general requirements for drug marketing approval and basic statistics.
• Knowledgeable of the FDCA and its implementing regulations in 21 CFR. Routinely surveil the regulatory landscape for trends and enforcements.
• Review and signature of FDA forms 2253 with approved promotional communications.
• Develop and provide presentations on hot topics/areas of interest to the Regulatory Affairs team.

Application Requirements

1. Curriculum vitae

2. Letter of intent - focusing on how a fellowship at Boehringer Ingelheim can help further your career growth. *Please upload under My Documents, Additional Attachments.

Requirements

• Doctor of Pharmacy degree from an ACPE-accredited school or college of pharmacy earned prior to the start date at Boehringer Ingelheim
• Strong intrapersonal, active listening, and problem-solving skills with an ability to work well in a team environment.
• Highly motivated and shows initiative in contributing to team deliverables.
• Receptive to receiving and quickly implementing constructive feedback.
• Ability to work independently within provided guidance from team leads.
• Adaptable and able to contribute to multiple Therapeutic Areas as needed.
• Excellent verbal and written communication skills.
• Proven experience working in a dynamic, high volume environment handling multiple tasks.
• Strong computer skills, including Outlook, Word, PowerPoint, and Excel.
• Foundational understanding of corporate structure, regulatory considerations and the drug development process in pharmacy with an ability to quickly adapt to a changing Corporate environment that will allow the incumbent to be productive in rotational experiences.

Desired Experience, Skills, and Abilities:

• Prior pharmaceutical industry experience (e.g. internship or Advanced Pharmacy Practice Experience [APPE] rotation is preferred but not required.)