This position will be responsible for Medical Information (MI) and Medical Review (MLR/MRC) functions for assigned products and/or indications, including working with the MI Call Center (MICC) vendor and the development of standard response documents and medical materials, management of escalations, and ability to collaborate effectively with cross-functional teams to achieve organizational objectives. The Associate Director will play a meaningful role in the medical review process and MI content/knowledge management within Acadia. They will be required to work collaboratively with other functional areas within Acadia to communicate accurate, consistent, and fair, balanced information regarding Acadia products and therapeutic areas.

Primary Responsibilities

• Works with MI vendor on handling inquiries received by the MICC and ensures accurate and timely responses to unsolicited medical information requests received
• Manages MICC inquiry escalations and provides guidance to medical team members for specific requests that require escalation
• Leads the development of verbal responses (FAQs) and standard response letters (SRLs)
• Builds and maintains the FAQ and SRL database for products in the market and in the pipeline
• Independently evaluates literature, interprets complex data, writes effectively, articulates information to a variety of audiences, and effectively negotiates with counterparts from cross-functional areas
• Supervise the development of MI Reports to assist with the identification of data gaps
• Coordinates with Medical Affairs colleagues, vendors and/or outsourced providers in the development, review and approval of medical materials; provides medical guidance and expertise to MLR and MRC teams in the review of promotional and medical materials during MLR/MRC meetings; participates in the review of promotional materials and medical materials to ensure medical accuracy
• Maintains an 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)
• Serves as subject matter expert on both general and specific Medical Review practices and provides executable recommendations to senior stakeholders as needed
• Develops MLR/MRC trainings to provide to cross-functional subject matter experts on MRC policy and MLR responsibilities to ensure consistent review process and rapid response with the aim of delivering high-quality material
• Provide support for the surveillance of various compendia
• Ensure compliance with applicable regulations, industry standards, and company policies related to medical information
• Anticipates risk and implements strategies to avoid potential problems. When appropriate, elevate to supervisor and other appropriate functional leaders as needed
• Other duties as assigned

Education/Experience/Skills

• Requires a PharmD, MD, or PhD in a scientific field
• Targeting 5 years of prior MI and MLR experience in pharmaceutical or biotech industry or relevant experience in medical affairs, medical communications, scientific affairs or similar area
• Previous experience in neurology or rare disease is preferred
• An equivalent combination of relevant education and experience may be considered

Key Skills:

• Collaborates cross-functionally to align Medical Information deliverables with the needs of the stakeholders (MSLs, Commercial, HEOR, R&D, etc.)
• Maintains expert-level understanding of product knowledge and labeling, associated disease states, relevant literature, treatment guidelines, competitor information, and brand strategies and tactics for the therapeutic areas involved
• Ability to work effectively, coordinate, and lead a multi-disciplinary, cross-functional team
• Experience in literature searches, literature evaluation, and drug information concepts
• Strong analytical and problem-solving skills
• Understanding the legal and regulatory environment of the pharmaceutical industry is desired

Physical Requirements

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, see, talk or hear in a standard office environment and independently from remote locations. Employee must occasionally lift and/or move up to 20 pounds. Ability to travel independently overnight and work after hours if required by travel schedule or business issues.

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