Associate Director Medical Review and Medical Information - Remote opportunity
Associate Director Medical Review and Medical Information - Remote opportunity
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$ 170000 - 200000
1 Vacancy
Job Description
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 highquality 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 crossfunctional leads including legal and regulatory to define an efficient and robust medicallegalregulatory (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 crossfunctional 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 PAetc.
- 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 crossfunctional teams.
- Experience working in a regulated industry such as pharmaceuticals biotechnology or medical devices.
PREFERREDEDUCATION EXPERIENCE and SKILLS:
- 5 years of experience in medical review
- 3 years of experience in medical information and scientific communication
- Excellent analytical problemsolving and decisionmaking 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 candidates geographical location qualifications skills competencies and proficiency for the role. Salary Pay Range: $170000 $200000 and eligibility for a 20 bonus target based on company and individual performance and eligibility to participate in the companys longterm incentive plan. 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 career site. Applications accepted on an ongoing basis #LILM1 LIRemote
Why Lundbeck
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 EVerify.
Required Experience:
Director
Employment Type
Full Time
