Job Description

Role Summary

The Associate Director, Medical Information and Review works closely with the Head of Global Medical Affairs Excellence to lead a high performing team responsible for medical information and medical review activities across Deciphera's portfolio. This individual is responsible for providing high-quality, timely, balanced and up-to-date medical and scientific information to internal and external customers, globally. The Associate Director is responsible for the management of Medical Review personnel providing the medical and scientific accuracy review of promotional and non-promotional materials across the portfolio. As necessary, this individual may support broader activities within Global Medical Affairs. The employee carries out this role in accordance with departmental SOPs, corporate policy, and other legal and regulatory requirements.

Key Responsibilities
Management of the Medical Information function - 75%

• Responsible for the creation, review, and approval of standard response letters (SRLs), FAQs, and other scientific materials
• Ensures scientific accuracy, compliance, and alignment with product labeling and regulatory requirements
• Oversight of the third-party contact center as it relates to: Compliance with workflow procedures and standards; Inquiries requiring escalation or customization; Conducting quality review of medical information cases and responses to ensure consistency and accuracy; New hire or ongoing therapeutic area/product training, as applicable
• Perform critical analysis of medical inquiry trends to identify key insights, develop evidence-based conclusions, and provide actionable recommendations that inform Global Medical Affairs strategic plans
• Lead medical information launch planning and execution for new products and indication expansion
• Ensure all medical information activities comply with applicable laws, regulations, and industry standards (e.g., PhRMA, FDA, EMA)
• Participate in internal audits and regulatory health authority inspections as needed
• Provide conference support including staffing the medical information booth and covering scientific sessions as needed
• Implementation of medical information best practices
• Supports various operational initiatives including development and maintenance of SOPs; training modules; database/system enhancements; identification of new innovative opportunities for dissemination of medical information.

Medical Review Process - 25%

• Oversee personnel tasked with ensuring medical accuracy of Deciphera's advertising, promotional and scientific materials as part of Promotional Material Review Committee (PMRC) and Medical Material Review Committee (MMRC), in collaboration with the Medical Affairs Medical Directors
• Ensure team is providing fact-checking of data points and verification that all claims and statements are adequately supported by appropriate references and properly cited in materials submitted to the PMRC/MMRC in a timely manner

Other duties and responsibilities as assigned.

Qualifications

Required Qualifications

• Advanced scientific degree in pharmacy (PharmD) or related science (PhD) with 5+ years of experience or MS with 10+ years of experience
• Deep understanding of regulatory and compliance frameworks (FDA, EMA, OIG, PhRMA)
• Understands the process for developing medical information response documents through the use of regulatory label, published medical literature, clinical study reports, posters, and abstracts
• Excellent written, verbal, and interpersonal communication skills
• Detail-oriented and self-motivated to drive for results
• Must be a strong team player with the ability to effectively collaborate with cross-functional team
• Ability to travel to meetings / conferences (domestic and international) approximately 20% of the time

Preferred Capabilities

• Prior experience working with medical information systems/databases (e.g., Salesforce) or promotional/medical review systems (e.g., Veeva PromoMats)
• Adept at learning new software / applications
• Training or past experience in rare disease or oncology therapeutic areas
• Experience working on product launches
• Working knowledge of US, European, and international regulatory requirements, guidelines, and compliance standards applicable to medical information operations

Additional Information

Deciphera is committed to fair and equitable compensation practices. The base salary pay range for this role is $167,000 - $230,000. Actual compensation packages will depend on various factors, including, but not limited to depth of experience, education, skillset, overall performance and/or location.

Deciphera believes in providing a competitive compensation and benefits package to all employees. Our base salary is just one component of Deciphera's competitive total rewards strategy that also includes annual performance bonus, a long-term incentive plan, full range of benefits and other incentive compensation plans (if applicable)

Benefits:

• Competitive salary and annual bonus.
• Comprehensive benefits package including medical, dental, vision insurance, 401(k) retirement plan with company match, and more.
• Generous parental leave and family planning benefits.
• Outstanding culture and opportunities for personal and professional growth.

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