AD, Sci Affairs Med Info & Med Review
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 Director, Scientific Affairs Medical Information and Medical Review is responsible for developing, maintaining, and continuously improving Medical Information (MI) assets and for review and approval of medical and promotional materials as part of the Human Pharma Review Committee (HPRC) review team. This individual will work closely with the Medical Affairs Strategy teams and Global Medical Information (MI) to ensure the timely development of scientific content for internal and external utilization based on customer needs and aligned with global MI content. This individual is also responsible for medical review of materials utilized by commercial and medical colleagues ensuring data is medical and scientifically accurate, not misleading, supported with appropriate context and is consistent with current medical perspective. Collaborating with all HP functions is expected to ensure timely support of any medical or commercial initiatives.
Strong expertise and knowledge of medical information will ensure for accurate and regionally appropriate preparation of scientific content, U.S. MI requests, process, system, and therapeutic area (TA) knowledge management, as well as support of compliance needs, and training for internal business functions and functional area vendors. The incumbent ensures a strategic, value-added MI organization by collaborating with a team that is well aligned with business priorities, Medicine strategy, customer initiatives, and maintaining a feedback mechanism with customers to improve Boehringer Ingelheim's MI assets and distribution.
The AD, Scientific Affairs Medical Information and Medical Review is also expected to be familiar with Brand and Medical strategies, FDA guidelines for advertising and promotional review, and current therapeutic area landscape to ensure appropriate and accurate execution of medical review as part of a cross collaborative review committee.
Duties & Responsibilities
Planning:
- Works with the TA to provide actionable strategic insights on customer MI needs in real-time and as part of local Medical Affairs Planning and in response to evolving external environment demands to support the development of medical strategies.
- Seeks input from key local and global HP stakeholders to ensure the alignment of strategies with both known and anticipated customer needs.
Response Content Management:
- Responds to medical inquiries from healthcare professionals and patients via phone, email, or other communication channels.
- Researches and provides accurate and evidence-based medical information regarding the company's products, including indications, dosing, safety, and efficacy.
- Supports the development and review of medical information materials, such as FAQs, Standard Scientific Response Content (SSRCs), dossiers, and training resources.
- Collaborates with cross-functional teams, including Global Medical Information, Medical Affairs, Regulatory Affairs, Patient Safety & Pharmacovigilance and other externally facing medical functions to ensure consistent and accurate communication of medical information.
- Document Management: Maintains accurate and up-to-date documentation of review activities, including tracking changes and providing feedback to stakeholders.
- Provides medical training and support to internal stakeholders, including sales representatives and medical affairs teams.
Medical Review:
- Reviews and provides medical and scientific expertise to ensure the accuracy, clarity, and compliance of promotional and non-promotional materials, including marketing materials, educational content, sales aids, and training materials.
- Medical Accuracy: Verifies the scientific accuracy, data integrity, and clinical relevance of content, ensuring alignment with current product information, clinical trial data, and approved indications.
- Cross-functional Collaboration: Collaborates with cross-functional teams, including medical affairs strategy, marketing, sales, legal, and regulatory affairs, to provide medical input and guidance throughout the review process.
Overall Medical Expertise and Support:
- Maintains a comprehensive understanding of product information, clinical data, relevant medical and scientific advancements, regulatory guidelines, and industry best practices.
Compliance:
- Performs all Company business in accordance with all regulations (e.g. FDA, “PhRMA Guidelines, etc.) and Company policies summarized in the BIPI Medical Information SOP and all relevant Local Working Instructions.
- Demonstrates high ethical and professional standards with all customers to maintain BIPI’s reputation within the medical and pharmaceutical community.
Training and Special Activities:
- Works directly with Medical Affairs Strategy and/or the Scientific Affairs Medical Information & Medical Review Team Lead to develop, enhance, and facilitate the ambassador program to develop internal awareness of MI group for CDMA and other cross-functional partners.
- Works collaboratively with Medicine Excellence Customer Facing colleagues to support vendor training.
- Provides support for department core functions as need arises for quality review, and training.
- May participate in external activities relevant to MI (e.g., DIA) to enhance individual and Boehringer Ingelheim reputation for MI excellence.
Requirements
- Advanced Degree Related to Healthcare focus (e.g., PharmD, NP/PA, MD, PhD) from an accredited institution.
- Minimum of two (2) years of experience in a clinical practice environment (including Residency training) as well as three-plus (3+) years of industry experience, preferably with experience in development and/ or medical affairs.
- At least three to five (3-5) years pharmaceutical industry experience or completion of a two-year Boehringer Fellowship program (in MI or equivalent as defined by medical information expertise).
- Possesses clinical knowledge of the assigned TA(s), understanding of the clinical development process, medical affairs functions, product commercialization, and pharmaceutical regulations and regulatory requirements.
- International experience may be relevant but knowledge and experience with US MI practice is essential.
- Must have experience in provide leadership and supervision of staff across medical information and third-party vendors and ensure compliance with existing SOPs, policies, and work instructions.
- Demonstrated customer focus and customer satisfaction as well as demonstrated continuous improvement of processes/assets.
- Demonstrated ability to work cross-functionally at the franchise level and at all levels across the enterprise.
- Exhibits flexibility in working collaboratively across internal and external stakeholders.
- Highly developed abilities in influence and working effectively through others.
- Demonstrated business acumen and judgment with ability to balance need for maintaining high scientific standards with business relevance and impact.
- Possesses excellent communication skills.
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.
Compensation
This position offers a base salary typically between $140,000 and $222,000. 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.