Associate Director, Medical Information & Medical Review

Mallinckrodt Pharmaceuticals•Malvern, PA

2d•$160,000 - $228,000•Onsite

About The Position

The Associate Director, Global Medical Information & Medical Review at Keenova Therapeutics, is responsible for leading and driving Medical Information activities for assigned therapeutic area(s) to meet the Keenova product information needs of external customers and internal business partners across the regions. The individual contributes to the management of medical communication services of unsolicited requests for information, creation of standard medical responses, FAQs, serve as medical reviewer, and other medical information deliverables. This role also includes responsibility for oversight or management of Medical Information Specialists/Managers, budget management of assigned activities, contributing to process improvement activities, and integration activities for Keenova Global Medical Information & Medical Review. The incumbent will report to the Senior Director, Global Medical Information & Medical Review and interact with a variety of corporate departments. These departments include, but are not limited to, Legal Affairs, Regulatory Affairs, Clinical Affairs, R & D, Manufacturing, Marketing, Quality Assurance, Sales, and Customer Service.

Requirements

Advanced degree in sciences or related field with 7+ years of experience in the pharma/biotech industry OR a combination of equivalent education and experience.
Strong scientific knowledge and expertise, including evaluating and communicating clinical data and disease state information to a wide range of audiences.
Demonstrated experience in conducting scientific literature reviews, and management of medical inquiries, including the development and review of medical information deliverables (e.g., standard medical response documents, FAQs, clinical compendium submissions, etc.)
Practical experience and knowledge of FDA guidance on appropriate scientific exchange practices.
Previous experience of managing/leading teams directly/indirectly and coaching, mentoring and developing talent to build individual and team capabilities.
Proficiency with Microsoft Office Suite software, Veeva Vault, customer relationship management software, and other technology and telephony systems.

Nice To Haves

Ability to identify and implement emerging technologies to optimize workflows and deliver innovative solutions.
Experience with AI tools, digital innovation, and data analytics to enhance medical information processes and insights.

Responsibilities

Oversee and manage tactical execution of the Medical Information component for assigned therapeutic area(s).
Develop and ensure high-quality, balanced, and scientifically accurate documents in response to medical inquiries from external customers and internal stakeholders; provide feedback on quality assurance measures and handle escalated inquiries as needed.
Lead and drive the development of Medical Information deliverables, including research and analysis of the scientific literature, standard medical responses (SMRs), verbal responses to FAQs, clinical compendium
Liaise with global and regional medical affairs colleagues as appropriate.
Participate in department training, process improvement activities, quality monitoring, and metrics tracking.
As needed. serve as medical reviewer, ensuring medical accuracy and provision of feedback for advertising, promotional, and medical materials as part of Promotional Review Team/Committee and Medical Review Committee.
As warranted, serve as a SME partner to internal and external collaborators support scientific exchange activities and address critical escalations.
Can provide direct supervision of Medical Information Sr Managers, Specialists, and contractors, as appropriate
Provide mentoring, guidance, and training for new hires/team members who may be less experienced.