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Confidential
Indianapolis, IN, United States
Vice President, Regulatory Affairs About the Company Innovative biotechnology company specializing in Alzheimer's disease therapeutics & diagnostics Industry Biotechnology Type Public Company Founded 1996 Employees 51-200 Categories Biotechnology Pharmaceuticals Academic Research Health Care Medical Care Medical Conditions Therapeutics Medical Diag
Job Source: ConfidentialIndiana Wesleyan University
Indianapolis, IN, United States
Assistant Vice President of Academic Affairs Apply now Job no: 493863 Work type: Administrative (Full Time) Location: Indianapolis, IN, Hybrid (2 Office / 3 Remote), Remote (within United States) Categories: Administrative/Professional Job Title: Assistant Vice President of Academic Affairs Reporting Relationship: Vice President of A
Job Source: Indiana Wesleyan UniversityRun my Accounts AG
Indianapolis, IN, United States
Location Greater Boston or Indianapolis area Role Description Acumen Pharmaceuticals is seeking an experienced and dynamic Vice President, Head of Regulatory Affairs to lead our regulatory strategy and ensure the successful development and commercialization of our Alzheimer's disease therapies. Reporting to the Chief Development Officer, the suc
Job Source: Run my Accounts AGIndiana Wesleyan University
Indianapolis, IN, United States
Assistant Vice President of Academic Affairs Job no: 493863 Work type: Administrative (Full Time) Location: Indianapolis, IN, Hybrid (2 Office / 3 Remote), Remote (within United States) Categories: Administrative/Professional Job Title: Assistant Vice President of Academic Affairs Reporting Relationship: Vice President of Academic Affairs
Job Source: Indiana Wesleyan UniversityIndiana Wesleyan University
Indianapolis, IN, United States
Assistant Vice President of Academic Affairs Job no: 493863 Work type: Administrative (Full Time) Location: Indianapolis, IN, Hybrid (2 Office / 3 Remote), Remote (within United States) Categories: Administrative/Professional Job Title: Assistant Vice President of Academic Affairs Reporting Relationship: Vice President of Academic Affairs
Job Source: Indiana Wesleyan UniversityEiteljorg Museum of American Indians and Western Art
Indianapolis, IN, United States
A Diverse Staff of Dedicated and Passionate People The Eiteljorg Museum seeks to attract, recruit, and support a diverse staff of talented people. We offer competitive packages and practice equal opportunity employment policies. In this section, find listings for any open positions. Vice President of Curatorial Affairs and Collections The Eitelj
Job Source: Eiteljorg Museum of American Indians and Western ArtEli Lilly
Indianapolis, IN, United States
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our commun
Job Source: Eli Lillytresvista financial services
, IN, United States
Responsibilities: A multi-faceted role requiring the individual to independently manage the data analyst team (~30 people initially and growing YOY) and reporting to the management. Mentor, train, and lead the team while engaging with clients on a strategic level and overseeing projects at a macro level. An individual at this position will be part
Job Source: tresvista financial servicesIndianapolis, IN, United States
Job Summary The Vice President, Medical Affairs is responsible for leading the development and execution of strategic and tactical plans for Headquarter (HQ) and Field medical affairs teams pre-launch, launch, and post approval for biosimilars and biologic products. This leader is an active and collaborative member of the Biosimilar Leadership Team (BLT). Leads local and collaborates on global product and business development activities. Serves as strong medical lead working with cross-functional counterparts regionally and globally to ensure strong execution against corporate goals and objectives in line with federal, state and company compliance requirements. Strong, motivational leader who builds and leads medical affairs team to ensure high quality, compliant execution against medical affairs performance goals.
*While this position may be worked remotely, qualified candidates must be permanently authorized to work in the U.S., and must work inside the U.S. Responsibilities Develop and ensure execution of impactful medical affairs strategy and tactics for HQ and Field teams to support product development, pre- and post-launch activities as aligned with the SVP, Chief Medical Officer.
Collaborate with direct reports and MSL Senior Managers/Field Directors to align on and oversee MSL onboarding, training, resource development and impactful execution of in-field territory plans across oncology and immunology.
Lead HQ team to ensure impactful strategic and tactical execution of key medical affairs initiatives including: IIT evaluation, study design/execution, evidence generation, multi-channel medical communication/education, consulting, MRL review and Medical Information.
Maintain a high level of professional expertise by staying abreast of the current medical landscape with regard to key therapeutic areas (e.g., oncology, immunology) and related products.
Work with broader Medical Affairs team to identify, build relationships with, and provide insights from, KOLs, decision makers and influencers in the HCP community.
Medical expert for US to review, develop, and approve clinical summaries in support of BLA, NDA, and ANDA applications.
Medical expert who provides, and trains others in the organization to provide, scientifically accurate, fair-balanced, clear, concise (yet comprehensive) medical information targeted to appropriate audiences regarding disease state, business landscape and key product information to external and internal customers.
Serve as a US medical expert/point person providing due diligence on business development opportunities for products in development as well as potential acquisition targets.
Train and facilitate other members of the team to train staff regarding current knowledge of disease/treatment landscape, applicable local and global regulations, standard operating procedures, and guidelines.
Responsible for writing, and/or training team to write/review relevant Standard Operating Procedures (SOPs) as needed.
Job Requirements
Medical/clinical professional degree required (PharmD, MD, PhD).
15+ years of experience in the pharmaceutical industry (predominantly in a medical affairs or clinical development role) required (supporting Biosimilars or Biologics preferred). Clinical experience will also be considered (7+ years preferred).
Pharmacology (PK/PD) knowledge and ability to communicate key concepts and study findings required.
Ability to understand and interpret the regulatory requirements under which drugs are developed, reviewed, and supported after approval.
Experience with the clinical drug development process.
Significant experience leading larger teams including HQ and/or Field required.
Clinical and scientific research and writing skills required. Ability to critically evaluate the published medical and scientific literature and approve and write comprehensive, medically accurate and scientifically fair-balanced documents.
Ability to understand and interpret FDA BLA (351 (a), (k)), NDA, and ANDA submission requirements.
Knowledge of PC systems and Microsoft Office Suite (Word, Excel) is required.
Up to 50-60% travel required.
Base salary range: $280,000-330,000
Additional Information We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company match, andwellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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Email Alert for Vice President, Medical Affairs jobs in Indianapolis, IN, United States
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