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? At Lundbeck, we are tirelessly dedicated to restoring brain health, so every person can be their best. Inspired and driven by our purpose, we are the only global biopharmaceutical company focused solely on brain diseases. We have a robust and innovative pipeline, bringing forward transformative therapies to address unmet needs in neurology and psychiatry. Join us on our journey of growth!

This is a remote opportunity - open to candidates anywhere in the United States

Summary:

The medical reviewer is responsible for medical review and approval of promotional and medical materials across all Lundbeck products. This individual is responsible for fact checking all materials against source documents and review to ensure scientific balance and medical accuracy of all materials. This individual will work closely with the medical, regulatory, and legal review functions. When needed lead medical information activities for specific products, including development of standard and custom written and verbal responses, clinical dossiers, standard and custom medical letters, Frequently Asked Questions (FAQs) and periodic review of inquiries and responses.

Essential Functions:

• Completes fact check of all materials for medical and scientific accuracy.
• Provides medical oversight for scientific review and approval of promotional, medical, and training materials in compliance with industry regulations
• Serves as a subject matter expert, providing medical and scientific expertise to commercial teams to support promotional claims
• Demonstrates broad knowledge of therapeutic areas, product labelling, and regulatory guidance
• Helps maintain current drug information resources by writing and/or reviewing standard and custom response documents as needed
• Provide review, editing and approval authority for standard response letters.

Required Education, Experience, and Skills:

• Accredited Bachelors degree or above in a scientific discipline (such as BS in Biomedical Sciences, BSN, Pharm.D., Ph.D,, MD, MMedSci, RN, etc.)
• 3 years of Medical Review experience with Medical Affairs or Regulatory Affairs in the pharmaceutical, biotech or medical device industry or at an agency that supports the pharmaceutical, biotech or medical device industries.

• Ability to critically evaluate medical literature and fact check materials against source documents
• Must pursue the highest level of accuracy in attention to smallest details
• Excellent communication skills (verbal and written) and the ability to convey materials on a peer-peer professional basis
• The Company requires all employees to be fully vaccinated against COVID-19 as a condition of employment. Newly hired employees must be fully vaccinated against COVID-19 and provide proof upon hire, or request a medical or religious accommodation

Preferred Education, Experience, and Skills:

• Experience in bioinformatics or Drug Informatics
• Working knowledge of regulatory guidelines
• Ability to perform complete literature searches for fulfillment of medical information inquiries
• Ability to critically evaluate, contextualize and synthesize the medical literature

Travel:

• Willingness/Ability to travel up to 10% domestically

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 and proficiency for the role. Salary Pay Range: $120,000 - $150,000 and eligibility for a 15% bonus target based on company and individual performance. Benefits for this position include flexible paid time off (PTO), health benefits to include Medical, Dental and Vision, and company match 401k. Additional benefits information can be found on our site.

#LI-LM1, #LI-remote

Why Lundbeck

Lundbeck is unique from other biopharmaceutical companies in that we are 70 percent owned by a research-focused foundation. We have a deep heritage of discovery and have brought breakthrough therapies to millions of people across the globe. And we're just getting started! Our success is driven by our great people and inclusive culture, which is guided by our beliefs of being Patient-Driven, Courageous, Ambitious, Passionate & Responsible. Are you ready to make an impact, one patient at a time? 

Lundbeck offers a robust and comprehensive benefits package to help employees live well and protect their health, family, and everyday life. Information regarding our benefit offering can be found on the U.S. career site.

Lundbeck is committed to working with and providing reasonable accommodations to disabled veterans and other individuals with disabilities during our employment application process. If, because of a disability, you need a reasonable accommodation for any part of the application process, please visit the U.S. career site.

Lundbeck is proud to be an equal opportunity workplace and is an affirmative action employer. We are committed to equal employment opportunity regardless of race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status, and any other characteristic protected by law, rule, or regulation. Lundbeck participates in E-Verify.