Senior Scientific Manager, Medical Affairs - Gastroenterology
Provides support for assigned products within gastroenterology therapeutic area. Primary responsibilities include performing the accurate and detailed scientific review of medical content for promotional and non-promotional materials and contributing to the creation of externally facing and training materials to meet customer needs. Functions in a scientific support role within assigned TA supporting on-market products. Acquires and establishes current therapeutic expertise necessary to serve as a scientific, medical, and clinical partner to field medical teams/affiliates, TA teams, brand teams, and R&D partners. This position must be based at our Mettawa, IL headquarters location following a hybrid schedule of Tues-Thurs in office. Responsibilities Responsible for 1 or more of the following: therapeutic area project work, major or complex product, multiple diverse indications for one product, or small functional team. Maintains expert understanding of product knowledge and labeling, associated disease states, relevant literature, treatment guidelines, competitor information, and marketing strategies and tactics for assigned therapeutic area(s). As necessary, assumes responsibility for diverse and/or complex projects regardless of therapeutic area. Assumes primary responsibility for medical review therapeutic team workload and projects to support key commercial and medical strategies. Anticipates and recognizes politically sensitive situations and tactfully manages the situation. Prevents political situations from arising. Establishes and maintains cooperative relationships with US and Global counterparts across functional areas (e.g., Global Medical Affairs, Commercial, Regulatory, Legal, Risk Management, Clinical Teams, and OEC). Promotional Material Review: Responsible for performing the accurate and detailed medical review of 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. Evaluate literature, interpret data, write effectively, articulate information to a variety of internal and external audiences and effectively negotiate with counterparts from cross-divisional functional areas. In an independent manner, critically evaluates literature, interprets complex data, writes effectively, articulates information to a variety of audiences, and effectively negotiates with counterparts from cross-divisional functional areas. Functions independently in timely decision-making while considering the broader impact to the organization. Confidently executes on and communicates decisions and rationale. Acts as a subject matter expert to internal customers or appropriate stakeholders to provide them with timely up-to-date scientific and clinical information necessary to make impactful business decisions. Serves as subject matter expert on both general and specific Global Medical Review practices and provides executable recommendations to senior management. Independently anticipates risk and implements strategies to avoid potential problems. Independently resolves higher risk or complex issues having the potential for financial, legal or regulatory implications. When appropriate, elevates to manager and/or Global Therapeutic Area lead. Mentors and/or oversees the onboarding of new employees. Demonstrates leadership, communication, and people development skills, including the ability to effectively listen and provide appropriate feedback and coaching specific to the developmental needs of others. Serves as a role model to peers. Informally responsible for team in manager’s absence. Within Therapeutic area, develops strategies and resources to address customer and department needs. Participates in strategic initiative planning and implementation and assists assigned manager with execution of therapeutic team strategies. Recommendations, actions and decisions made are critical to ensure compliance with applicable regulatory standards pertinent to the promotion of pharmaceutical products. The actions of this position impact decision-making regarding company products with respect to patient safety and prescribing behavior. Aids in the broader teams ability to address educational scientific gaps identified through the gathering of feedback from multiple field sources, compile and summarize to provide relevant insights. Development of non-promotional field/affiliate resources: Develops non-promotional field/affiliate resources and ensures communications are supported by medical communication standards, pharmacovigilance standards, SOP’s and all other quality and compliance standards in Medical Affairs. Provides input into externally facing materials for use as directed: (i.e. Congress Booth, Ad Boards, Med Ed) with HCP or EE interactions (Payer, Patients, Prescribers, and Providers); educational initiatives (medical education, data, guidelines, and value proposition) Scientific degree required; advanced degree (e.g., MS, PhD, MD/DO, PharmD, NP, MSN) preferred. 2-3 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. Understanding of relevant therapeutic area required. Basic knowledge of clinical trial design, results and methodology, regulatory and compliance requirements governing development of promotional and non-promotional materials is desirable. Demonstrated analytical, conceptual and administrative skills. Excellent communication skills (written and presentation). Flexibility and adaptability to organizational change and business priorities.  Ability to work in a fast-paced corporate environment. High sense of urgency and commitment to excellence in the successful achievement of objectives. Excellent pl
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