Provides medical and scientific strategic and operational input for core HCV medical affairs activities such as strategic planning, health-care professional and provider interactions (Payers, Patients, Prescribers, and Providers); generation of clinical and scientific data (enhancing therapeutic benefit and value); educational initiatives (medical education, data, guidelines, and value proposition); safeguarding patient safety (risk minimization activities and safety surveillance activities). Works closely with sales, marketing and commercial teams to provide strategic medical input into core brand (product) strategies, and to support medical and marketing activities (promotional material generation) and market access.
Key Responsibilities include:
- Responsible for design, analysis, interpretation and reporting of scientific content of protocols, Investigator Brochures, Clinical Study Reports, real world data, updated regulatory submissions and responses and other program documents.
- Provides in-house clinical expertise for the molecule and disease, coordinating appropriate scientific activities with internal stakeholders as they relate to ongoing medical affairs projects.
- May serve on a Strategy Team with responsibility for development of a rigorous, cross-functionally-aligned, vetted Integrated Evidence Generation Development Plan with full consideration of contingencies and alternative approaches.
- Leads development of TA EE Engagement Plan. Actively solicits opinion leader interactions related to the molecule and disease area; partners with other functions in these activities as required, consistent with corporate policies, to ensure that broad cross-functional perspectives are incorporated into insights and strategy.
- Contributes to the development of brand strategies.
- Contributes to the development of and leads the execution of the Medical Education
- Contributes/ leads Advisory Board & EE Engagement Plan generation in line with TA plan
- Contribute to US Conference planning and execution.
- Generates clinical and scientific data (DOF) as needed to support external communication (RRTI).
- Responsible to manage budget for assigned projects.
- Aligns Medical education and scientific initiatives with Sci Comm Platform. Informs Investigator Initiated Study (IIS) strategy and can act as Docent for IISs.
- Contributes to the generation of MI communication content and supports training on Medical Information (MI) materials.
- Participation in design and execution of clinical trial safety, product safety and risk management plans. Track RMP implementation.
- 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.
- Stays abreast of professional information and technology through conferences, medical literature and other available training, to augment expertise in the therapeutic area.
- Ensures adherence to Good Clinical Practices, pharmacovigilance standards, standard operating procedures and to all other quality standards in conducting research.
- Advanced Degree PhD, PharmD, PA, NP highly preferred. Residency or additional post doctorate experience highly preferred.
- 8 years’ experience in the pharmaceutical industry or equivalent; substantial understanding of relevant therapeutic area required.
- Ability to provide input and direction to clinical research with appropriate supervision. 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. Must possess excellent oral and written communication skills.
- Works with minimal supervision and guidance. Exercises judgment within well-defined practices and policies.
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action employer, we do not discriminate on the basis of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, protected veteran status, or any other legally protected characteristic. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.
Significant Work Activities: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)Keyboard use (greater or equal to 50% of the workday)
Travel: Yes, 25 % of the Time
Job Type: Experienced