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, and proficiency for the role. Salary Pay Range: $170,000 - $200,000 and eligibility for a 20% bonus target based on company and individual performance, and eligibility to participate in the company’s long-term 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  #LI-LM1, LI-Remote

 

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 E-Verify.

.buttontext539cb4e5704cb8aa a{ border: 1px solid transparent; } .buttontext539cb4e5704cb8aa a:focus{ border: 1px dashed #a5a07b !important; outline: none !important; } About Lundbeck

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

/* Styles for mobile screens */ @media (max-width: 1199px) { .inner iframe { width: 365px; height: 205px; padding-top: 10px; padding-bottom: 10px; }} About Lundbeck

 

At Lundbeck, our most important contribution is easing the burden of the millions of people living with brain disorders. Whether it is migraine, depression, or other brain disorders, patients, their carers, and society as a whole depend on us.

Through cutting edge science and strong partnerships, we develop and market some of the world’s leading treatments, expanding into neuro-specialty and neuro-rare from our strong legacy within psychiatry and neurology.

The brain health challenge is real. Our commitment is real. Our impact is real.

.video-container{ display: flex; flex-direction: row; /* Set flex-direction to row */ max-width: 1200px; padding-top: 20px; } .column { flex: 1 1 30%; margin-right: 20px; } .column:last-child { flex: 1 1 70%; /* Adjust the last column to 60% width */ margin-right: 0; } /* Styles for desktop screens */ @media (min-width: 1200px) { .inner iframe { width: 420px; height: 235px; padding-top: 5px; }}

Apply now » Find similar jobs: Research and Development Home Contact us Careers Job opportunities Join talent community Data privacy notification

© Copyright 2024

.onoffswitch .onoffswitch-inner:before { content: "Yes"; } .onoffswitch .onoffswitch-inner:after { content: "No"; } × Cookie Consent Manager

When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer.

Required Cookies

These cookies are required to use this website and can't be turned off.

Show More Details Required Cookies Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function:
"route" is used for session stickiness"careerSiteCompanyId" is used to send the request to the correct data center"JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor"Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another Confirm My Choices Reject All Cookies Accept All Cookies /* Left align footer links */ @media (min-width: 1200px){ ul.inner { padding-right: 0px !important; margin-left: 0px !important; padding-left: 0px !important; margin-right: 0px !important; }} /* Left align footer links */ @media (min-width: 1200px){ #footerRowTop { padding-left: 0px; padding-right: 0px; }} /* Left align footer info */ @media (min-width: 1200px){ #footerRowBottom { padding-left: 0px; }} /* Left align footer info */ @media (min-width: 1200px){ #footerRowBottom > div:nth-child(1) > p:nth-child(1) { padding-left: 0px; }} /* Set the size of the icons */ .social-icon .fa { height: 35px; width: 35px; font-size: 35px; color: inherit; } /* Right align social icons */ @media (min-width: 1200px){ li.social-icons:nth-child(3) { margin-right: 0px !important; }} /* Align links and social */ @media (min-width: 1200px){ ul.inner { padding-top: 12px !important; }} // // // const jobAlertSpans = document.querySelectorAll("[data-testid=jobAlertSpanText]"); jobAlertSpans?.forEach((jobEl) => { jobEl.textContent = window?.jsStr?.tcjobresultscreatejobalertsdetailstext || ""; }); // // //