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Remote-Medical Director - Plainsboro, United States - BioSpace, Inc.
Description
Job DetailsAbout the Department
The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the organization.
From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting data to support efficacy and new product development, CMR is involved.
The one thing that keeps us all marching to the same beat is our patient-centered focus. At Novo Nordisk, you will help patients around the world.As their needs evolve, so does our challenge to find better and more innovative ways to improve their quality of life.
We're changing lives for a living. Are you ready to make a difference?The Position
The Medical Director serves as the subject matter expert for our products and related data within a Therapeutic Area (Diabetes-GLP-1, Diabetes-Insulins, Cardiorenal Diseases, Obesity, NASH, Rare Blood Disorders, Rare Endocrine Diseases, and neurodegenerative diseases).
This role will interface with key stakeholders across CMR, Marketing, and the Global organization to drive scientific exchange and communication with external Key Opinion Leaders (KOLs), Healthcare Professionals (HCPs), and other stakeholders.
The Medical Director will also assist the Senior Medical Director in the development and execution of strategic priorities within a therapeutic area, including developing the medical product and evidence generation plans based on insights from the marketplace.
This role may also lead the Core Medical Team, Project Team (co-chair), and National Advisory Board meetings for a Therapeutic Area in certain instances, at the discretion of Executive Director of Medical Affairs.
Assists the Senior Medical Director in developing agenda for and executing national advisory boards, assists with defining strategies to support medical education programs and reviews IME grant proposals, represents Medical Affairs in Promotional Review Board (PRB) activities including reviewing medical and scientific content of promotional materials, maintains KOL relationships and serves as a consultant for Marketing, FMA, SCOE, Market Access, Public Affairs, and Sales.
Assist with the development of strategies to appropriately position the Brand as part of the Novo Nordisk portfolio.Relationships
This position reports directly to the Executive Director, Medical Affairs and will assist the Executive Director and Sr. Director (where applicable) in managing multiple internal relationships within Novo Nordisk Inc. and Global HQ.
Key internal relationships include Field Medical Affairs, Medical Strategy & Operations, Medical Information, Publications, Clinical Directors, HEOR Directors, Global Medical Directors, Marketing, and Market Access.
External relationships include expert advisory board members, investigators, other consultants, and key customer groups. Contribute to PPG and Brands EBT.Essential Functions
Evidence Generation
Provide input to Product Development Plan (PDP) and Evidence Generation Plan (EGP), in collaboration with Senior Medical Director
Serve as NNI Medical Affairs representative on Medical & Science Team
Review and provide comments to trial outlines/protocols for Novo Nordisk-sponsored clinical trials
Review proposals for investigator-sponsored studies (ISS) and provide comments to RGC Chair
Attend Research Grants Committee meetings and participate in decisions for ISS proposals
Assist with identification and support of National Leaders/National Expert Panels for select clinical trials, in collaboration with Clinical Director and Clinical Operations lead
Support investigator meetings
Serve on Clinical Trial Strategy Team in collaboration with Clinical Operations point, Clinical Director, and Field Medical Affairs point to identify investigators/sites and risks to trial planning and execution
KOL and Association Engagement
Assist Senior Medical Director with planning and execution of National Advisory Board meetings (or lead planning and execution of National Advisory Board meetings, at the discretion of Executive Director)
Deliver clinical data and other presentations at National Advisory Board meetings and gain feedback from advisors
Support other advisory boards with clinical data and other medical presentations
Partner with professional associations and their leadership to identify shared goals and initiatives, in collaboration with Public Affairs/Alliance Development team
Publication Planning
Serve on Publication Planning Group, where relevant
Review and provide comments to abstracts, posters, and manuscripts, including primary, secondary and HEOR publications
Prepare and support presenting external authors
Develop local US publication plan (including encore abstracts, reviews, and supplements) in collaboration with Publications Manager
Independent Medical Education (IME)
Assist in developing medical education priorities and IME plan in collaboration with IME lead
Review and assist with selection of proposals for IME grant funding
Medical Guidance
Train Field Medical Affairs team on relevant disease state topics and clinical trial data. Review and approve resources for FMA
Train Sales Teams on clinical trial data and Prescribing Information
Train Market Access team on clinical trial data and Prescribing Information
Review and approve Medical Information letters, including standard and custom letters
Review and provide comments to AMCP dossier
Support Speakers' Bureau, including presentations at Speaker Training and Curriculum Development meetings
Provide medical review of all materials for PRB for launch products
Provide input and support to Medical Information lead for PRB for non-launch products
Provide medical guidance to Marketing, including for development of materials for PRB and serving on Extended Brand Team (EBT)
Serve on Extended Medical Team (EMT) and assist with development of Medical Product Plan (medical strategies and tactics). In certain situations, may serve as chair of Core Medical Team, at the discretion of the Executive Director
Represent NNI Medical Affairs on Global Core Medical Team (CMT)
Collaborate with HEOR to provide clinical input on HEOR projects and authorship on abstracts, posters, and manuscripts, when requested
Serve on Local Labeling Committee (LLC) and provide medical input to Regulatory Affairs
Physical Requirements
30% overnight travel required.
Position can be based anywhere in the US-Remote; Must be located near a major airport and able to travel to Plainsboro, NJ regularly.
QualificationsAn advanced Health Care or science degree required (e.g.-MD, DO, PhD, or PharmD)
A minimum of 5 years of combined clinical, research or Pharma experience
Experience in relevant therapeutic area strongly preferred (CV Renal)
Strong strategic mindset, understanding of market needs, resource allocation, etc.
Strong tactical familiarity with the design, overseeing and assessment of clinical trials and with other MA tools
Strong expertise in clinical trial methodology and conduct, GCP principles, medical product support activities, publications, ISS, med ed
Ideally experience with launches with generic market dominance or payer experience
Prior experience working with an affiliate with a global HQ
The base compensation range for this position is $[250,000] to $[285,000]. Base compensation is determined based on a number of factors. This position is also eligible for a company bonus based on individual and company performance. Novo Nordisk offers long-term incentive compensation and or company vehicles depending on the position's level or other company factors.
Employees are also eligible to participate in Company employee benefit programs including medical, dental and vision coverage; life insurance; disability insurance; 401(k) savings plan; flexible spending accounts; employee assistance program; tuition reimbursement program; and voluntary benefits such as group legal, critical illness, identity theft protection, pet insurance and auto/home insurance.
The Company also offers time off pursuant to its sick time policy, flex-able vacation policy, and parental leave policy.The job posting is anticipated to close on April 23rd, 2024.
The Company may however extend this time-period, in which case the posting will remain available on our careers website at www.novonordisk- .
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world.
We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.
We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.
Together, we're life changing.Novo Nordisk is an equal opportunity employer.
Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.
If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
