Assistant Scientific Director, US Medical Affairs- Specialty Established Products

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Overview

The Assistant Director, Medical Affairs has a key role within the Established Products team. This role supports the development and execution of the therapeutic area medical strategy, specifically as it pertains to the specific asset or indication by providing scientific, strategic and operational input into core medical affairs activities including, ensuring the scientific and medical accuracy, clinical appropriateness, and compliance of advertising and promotional materials used to communicate information about our products and contributing to drug safety activities, including data analysis, risk assessment, and collaboration with internal and external stakeholders. Works closely with commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical and marketing activities (promotional material and product lifecycle management) and market access.  Collaborates with clinical development on Medical Affairs support of phase IV trials or post-marketing requirements; Collaborates with Pharmacovigilance & Patient Safety and Regulatory Strategy & Labeling Teams on Med Affairs support of label changes and review of safety reports.

Key Responsibilities:

•Responsible for performing the accurate and detailed medical review of complex advertising and promotional materials for assigned therapeutic area(s) within Medical Affairs. Provides timely and accurate reviews of promotional materials in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs.

•With oversight, contributes to the development of the therapeutic area and brand strategy.

•Represents AbbVie at external meetings including scientific meetings, etc.

•Generates clinical and scientific data (DOF) as needed to support external communication (RRTI).

•Provides subject matter expertise for commercial teams including competitive assessments and regular scientific literature reviews.

•Collaborates with GMI (Global Medical Information) to support writing new standard response letters when needed, informing GMI of approved FAQs, and review of customer inquiries to highlight any gaps in patient/HCP education

•Collaboration with cross-functional teams such as Marketing, Legal, Regulatory Affairs Ad Promo, Medical Affairs, Commercial, Pharmacovigilance & Patient Safety, Reg Strategy and Reg Labeling

•Review of Periodic Safety Update Reports (PSURs) and Periodic Adverse Drug Experience Reports (PADERs) to ensure regulatory compliance and timely delivery.  Contribute to the development and implementation of risk management strategies. Medical input into safety assessments and label updates if applicable.

•Supports clinical and scientific data generation including alignment of the Investigator Initiated Study (IIS) strategy as needed to support external communication

•Other potential duties may include contributing to the monitoring of medical literature, supporting sales training, staying updated on FDA regulations and industry trends.

Education/Experience:

•Scientific degree; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred.
•3-5 years of clinical, scientific/research, or industry related experience or equivalent required demonstrating strong leadership competencies and proven team-building skills with ability to lead in a global matrixed environment. Substantial understanding of relevant therapeutic area required.
•Good understanding of legal and regulatory guidelines (e.g. knowledge of OPDP promotional regulations, CDER/CBER regulations as they relate to drug approvals).
•Good understanding of Good Clinical Practices, ICH guidelines, PhRMA code, FDA CFR, ISO, clinical research ethics, HIPAA and patient privacy laws, EU Directive and other applicable local regulations
•Good understanding of Medical Affairs principles, study design and publications.
•Knowledge of clinical trial methodology, regulatory requirements governing clinical trials and experience in the design of protocols preferred.
•Interactions normally require the ability to gain cooperation of others, conduct presentations of technical information concerning specific projects and schedules, etc.
•Ability to interact externally and internally to support global business strategy. Ability to work effectively with different cross functional groups and have strong interpersonal and communication skills.
•Able to coordinate appropriate scientific and medical activities with internal stakeholders (i.e. commercial, clinical operations, discovery, statistics, regulatory, etc.) as they relate to on-going medical affairs projects.
•Ability to work effectively in a team/matrix environment. Ability to influence others without direct reporting relationships.

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: ​

• The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. Salary:​ $156,000 - $296,500

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.​

• This job is eligible to participate in our short-term incentive programs. ​

• This job is eligible to participate in our long-term incentive programs​

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Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law. ​

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community.  Equal Opportunity Employer/Veterans/Disabled. 

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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