Associate Director, Medical Information

The Associate Director (AD), Medical Information & Review will participate in the medical review and approval of external communication materials.

The AD will be responsible for providing and supporting the provision of accurate, scientifically balanced, and timely responses to inquiries received from health care professionals, consumers, and other customers about Alkermes products.

The AD will monitor the scientific literature and communicate new data to relevant internal groups. The AD will assist in the development of core medical information materials for internal and external stakeholders.

The AD will ensure medical accuracy of external communication materials related to our products. Candidates applying for this position must have the ability to take initiative and work independently, requiring minimal supervision.

This position is within the Alkermes Medical Affairs department and will report to the Director of Medical Information. Alkermes has a hybrid work environment, and this role will operate in a flexible environment with 60% of time in the office and 40% remote.

Responsibilities : Medical Information

Medical Information

• Independently research and write medical response documents, proactively update existing response documents on an ongoing basis, obtain approval for use to ensure compliance with existing regulations, policies and procedures, and train others on their content and use
• Receive, identify, document, and triage adverse events and product complaints to ensure compliance with health authority regulations and internal procedures
• Provide accurate, balanced, and timely medical and scientific information to internal and external customers such as health care professionals, consumers, and other customers
• Perform quality monitoring of inquiry handling, ensure identification and reporting of potential adverse events and product complaints, and triage accordingly to PV and QA policies and procedures
• Perform critical analysis of inquiry trends, contributing conclusions and recommendations based on findings, to medical affairs strategy teams
• Provide scientific conference support including leading pre-conference activities, attending the conference to provide medical support and to staff the medical information booth, and develop post-conference reviews and reports for internal stakeholders
• Provide guidance and training to the medical information call center pharmacists and nurses

Medical Review

• Review promotional and medical communication materials for medical accuracy and appropriateness
• Regularly collaborate with reviewer colleagues in Regulatory and Legal functions to provide expert direction for both commercial and medical document owners
• Create and / or review communications containing medical and scientific content intended for internal and external customers (eg, communications Q&A material, dear healthcare provider letters, documents for public comment)

Cross Functional / Organizational

• Apply knowledge of business strategy and inquiry activity to identify business needs, trends and emerging issues, raising awareness with appropriate Alkermes colleagues.
• Proactively monitor the literature for new scientific information, identify relevant publications, analyze, and communicate information of interest internally in an accurate, balanced, and timely manner
• Ensure compliance with company policies and procedures
• Provide medical and scientific input and contribute to assigned product and project teams
• Provide information and support for business activities such as relevant insights, knowledge of product data, etc.

Education and Experience

Advanced scientific degree (PhD, MD or PharmD) with 3-5 years of experience in medical information, medical / promotional review, and medical affairs, with increasing levels of responsibility

Minimum Requirements

• Fluent in medical information, relevant US regulations, guidelines, standards, and best practices
• Fluent in copyright and privacy standards
• Fluent in medical information related technology solutions, inquiry databases, reporting, etc.

Preferred Requirements

• Ability to travel (typically 5-15%)
• Ability to work in a fast-paced environment with competing priorities
• Ability to read, interpret, and convey complex scientific information
• Ability to work independently with minimal supervision
• Ability to collaborate cross-functionally with internal and external partners
• Excellent written and verbal communication skills
• Exceptional interpersonal skills
• Ability to work collaboratively toward a common goal with a focus on developing solutions
• Experience leading formally or informally in a team environment
• Demonstrated results-orientation and problem-solving skills

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