Associate Director Medical Review and Medical Information - Remote opportunity

Do you want to join a team where the mission is meaningful, the challenges are complex, and you can directly see the results of your hard work? Lundbeck is a global biopharmaceutical company focusing exclusively on brain health. With more than 70 years of experience in neuroscience, we are committed to improving the lives of people with neurological and psychiatric diseases. Lundbeck employees are inspired and driven by our purpose to advance brain health and transform lives. Join us on our journey of growth!

 

Remote opportunity - Open to candidates anywhere in the greater United States

 

POSITION SUMMARY:

The Associate Director, Medical Review and Medical Information, will serve as the sole subject matter expert for medical affairs. This role is responsible for delivering timely, accurate and detailed scientific/medical review, ensuring high quality, balanced, and prompt medical information deliverables. Additionally, this role is responsible for ensuring strategic alignment and proactively identifying process efficiencies as well as how technology/AI can advance our work across therapeutic areas for Lundbeck US. Importantly, this role is an integrated part of the broader business unit, necessitating strong cross functional and within function collaboration skills.

 

ESSENTIAL FUNCTIONS:

• Leverage robust experience in medical review and medical information, including experience in launches and label updates, to plan, develop, and ensure high-quality, balanced, and timely medical review and scientific deliverables
• Proficient in special projects such as drug recalls, PSUR/PBRER reporting, FAQ creation, labeling and safety committee related projects/participation, and/or REMS.
• Oversees call center support and medical writing agency to ensure all medical information inquiries are responded to in compliance with US timelines
• Demonstrates partnership and collaboration with cross-functional leads, including legal and regulatory, to define an efficient and robust medical-legal-regulatory (MLR) partnership within Lundbeck US.
• Governs the Lundbeck US Medical Affairs Review Committee (MARC) process to ensure efficient and accurate delivery of key medical materials
• Accountable, in collaboration with Scientific Communications, to ensure content meets highest quality and scientific accuracy.
• Oversees strategic assessment (gap analysis) of medical information and medical review needs within therapeutic areas and develop fulfillment strategies.
• Ensures compliance for medical affairs and cross-functional teams through awareness and training of policies and procedures, specific to medical information and medical review.
• Actively contributes and collaborates with the Medical Strategy Teams through appropriate and timely updates, reports, metrics and discussions.
• Proactively evaluate opportunities to leverage AI to elevate quality of medical communications and drive towards efficiencies. 
• Analyze medical information trends, insights and educational gaps to share with key internal stakeholders.

REQUIRED EDUCATION, EXPERIENCE, and SKILLS:

• Accredited advanced scientific degree (Pharm.D., Ph.D, MD, MS, PA etc.)

• 5+ years of experience in medical review, medical information and scientific communication
• Strong leadership skills, with a demonstrated ability to influence without authority.
• Demonstrate a working knowledge of US regulatory guidelines including FDA product promotional guidance, PHRMA Guidance and OIG, Guidance for pharmaceutical manufacturers.
• Strong communication and interpersonal skills, with the ability to collaborate effectively across cross-functional teams.
• Experience working in a regulated industry, such as pharmaceuticals, biotechnology, or medical devices.

 

PREFERRED EDUCATION, EXPERIENCE, and SKILLS:

• 5+ years of experience in medical review
• 3+ years of experience in medical information and scientific communication
• Excellent analytical, problem-solving, and decision-making skills.
• Proven track record of driving process improvements and achieving operational excellence.
• Ability to adapt to changing priorities, manage multiple projects simultaneously, and meet deadlines
• Experience within Veeva and IRMS systems

 

TRAVEL:

• Willingness/Ability to travel up to 20% domestically. International travel may be required

The range displayed is a national range, and if selected for this role, may vary based on various factors such as the candidate’s geographical location, qualifications, skills, competencies,