Manager Global Medical Communications
Abbott is a global healthcare company devoted to improving life through the development of products and technologies that span the breadth of healthcare. With a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals, Abbott serves people in more than 150 countries and employs approximately 70,000 people.
PRIMARY JOB FUNCTION:
Responsible for providing complex medical information or performing medical review of complex advertising and promotional materials for designated products from the Established Products Division (EPD).
This includes providing expert medical responses to unsolicited requests for medical information and managing the development, approval, and maintenance of medical and technical responses to inquiries on products from internal customers such as affiliates and other scientific colleagues as well as from external customers including healthcare professionals and consumers. It also includes ensuring the accurate and detailed medical reviews of worldwide commercial advertising and promotional materials. Information provided must be in compliance with global regulatory requirements.
CORE JOB RESPONSIBILITIES:
Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
Provides timely and accurate medical information or promotional reviews in accordance with established policies and practice standards, including regulatory guidelines to meet customer needs. Ensures deliverables convey a clear and appropriate medical message.
Maintains in-depth understanding of product knowledge, associated disease states and treatment guidelines, labeling, and relevant data for assigned therapeutic area.
Has solid understanding of the Pharmacovigilance and Product Quality reporting requirements and their impact on medical information and promotional review activities. Reports events as appropriate.
Establishes and maintains cooperative relationships with counterparts across functional areas (eg, Marketing, Regulatory, Legal, Clinical Teams, and Public Affairs).
Applies knowledge across multiple therapeutic areas to support departmental initiatives.
Applies solid understanding of regulations, knowledge of current regulatory opinion/guidance, political/legal climate and industry practices/ trends to the dissemination of medical information and promotion of pharmaceutical products.
Working with colleagues and manager, 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.
Leads team, departmental, or cross-functional goals and projects. Develops, implements, and evaluates appropriate work tools and methodologies to enable Global Medical Communications to continually improve processes, performance, and productivity.
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.
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.
Recognizes and resolves project risks associated with content of promotional materials, and other medical communications. Develops medical defense and alternative solutions to medical presentations to mitigate business risks. Appropriately advises management of project risks and presents recommendations for resolution.
Serves as a subject matter expert for training purposes. Coordinates training across functional and global boundaries to ensure timely, accurate and quality medical communication.
Maintains composure and demonstrates leadership during times of change.
Ensures organizational compliance, serves as ethical leader, and proactively identifies and resolves gaps.
Recognizes politically sensitive situations and brings them to management’s attention for appropriate navigation of organizational dynamics.
Provides Medical Information standard response review. Serves as a medical writing mentor to peers.
Uses problem-solving skills to identify areas for improvement and create a more efficient workflow. Makes good decisions based upon a mixture of analysis, wisdom, experience, and judgment.
Prioritizes multiple activities to accomplish individual and departmental goals, while using resources effectively and efficiently.
Identifies and employs rigorous logic and methods to independently and effectively solve difficult problems, while encouraging innovative solutions.
Probes all fruitful sources for answers, looks beyond the obvious and doesn’t stop at the first answers. Remains objective and cognizant of bias.
Can see hidden problems; is excellent at honest analysis; doesn't over-analyze.
Defends proposed or enacted solutions to more senior level management.
Identifies and anticipates potential departmental problems impacting ability to meet business goals; proactively develops and implements methods of improvement and resolution.
POSITION ACCOUNTABILITY / SCOPE:
Provides cross-functional direction and negotiation of Medical Communication responsibilities and compliance issues.
Independently recommends and implements changes to complex projects based on medical knowledge and expertise, accurate interpretation of
regulations, guidelines, and corporate policies, in consideration of management direction.
Responsible for high impact and visible departmental project(s).
Maintains expert knowledge of product data, literature, labeling, marketing objectives, and key product issues.
Develops and executes departmental and therapeutic area strategies. Responsible for supporting the division and company’s strategic direction and goals.
Ensures team compliance with regulatory and corporate requirements to avoid audits, warnings, penalties, and sanctions by regulators worldwide.
Works in partnership with applicable cross-functional areas to meet the medical communications business needs, and functions independently in high-level decision-making for project-related issues that have departmental and cross-functional impact.
In conjunction with manager, reviews both successes and setbacks to build problem-solving expertise for complex issues.
Appropriately identifies when to independently address the issue with other departments and when to elevate the issue for management involvement.
Recommendations, actions and decisions made are critical to ensure compliance with applicable regulatory standards pertinent to medical information and promotion of pharmaceutical products.
Bachelor’s degree and graduation from an accredited Nursing, Pharmacy, PhD (Health Sciences), or MD/DO program. Advanced degree preferred. Achieved licensure for professional practice, if appropriate, for field.
- Minimum of 2 years pharmaceutical industry work experience OR 2 years postgraduate training in the pharmaceutical industry. OR Minimum of 4 years of licensed clinical practice experience.
Significant Work Activities and Conditions
Continuous sitting for prolonged periods ( more than 2 consecutive hours in an 8 hour day)
- Excellent interpersonal, communication, and leadership skills, including the ability to effectively listen and provide appropriate direction on medical and technical aspects of supported products.
- Demonstrates cultural sensitivity.
- Able to coordinate and lead multidisciplinary and cross-divisional meetings.
- Solid clinical understanding of disease states and the implications of treatment. Demonstrated ability to interact with healthcare professionals.
- Strong critical thinking skills to identify medical issues, suggest alternatives, and negotiate effective solutions.
- Strong knowledge of clinical trial methodology, statistical concepts, and independent evaluation and interpretation of complex literature.
- Applies understanding of regulatory and compliance requirements to medical communications, advertising, and promotion.
- Maintains in-depth understanding of product knowledge, labeling, and relevant data. Able to apply knowledge across multiple therapeutic areas.
Yes, 10 % of the Time
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