Medical Director Medical Affairs
Deerfield, IL
Req ID 51425BR
Business Title
Medical Director, Medical Affairs
Business
Medical Products
Sub-Business
Research & Development
Country
US
State/Province
Illinois
Location of Position
Deerfield, IL
Shift_
1st
Job Description
The Medical Director is primarily responsible for medical strategies related to development programs and sustaining product activities in the Fluid Systems franchise involving intravenous (IV) solutions, containers for IV solutions and devices for delivery of IV solutions. The Medical Director is also responsible for preparation of clinical sections for registration and re-registration submissions to regulatory authorities worldwide for marketing approval as well as maintenance of existing product licenses. The Medical Director participates on strategic teams including the identification of new product opportunities as well as life-cycle management programs. The Medical Director will provide Medical perspective and expertise in the therapeutic applications of IV solutions and containers for IV solutions. The Medical Director will provide medical technical perspective to the Business Development and Portfolio Management functions in the identification of potential partnering and internal opportunities. The Medical Director provides expertise with counterparts in other functional areas such as Engineering, Quality, Regulatory Affairs, R&D, Marketing, and Clinical Development /Operations. The Medical Director develops and maintains strong scientific and medical relationships with consultants as needed to support products within the Fluid Systems Franchise.
The Medical Director will:
•Provide medical and scientific direction on clinical matters affecting preparation and submission of timely and sound information to the worldwide regulatory agencies.
•Work with product development and marketing functions to define the requirements and specifications for new products.
•Be capable of developing communication plan, including publication plans for the therapeutic area.
•Review and approve documents needed to support products, such as CCSIs, PSURs, SBRs, label updates, etc.
•Drive the development of rational strategic plans for future products and provide strategic leadership to the clinical R & D and medical affairs activities associated with technical support for products in the global market.
•Develop and maintain knowledge as to developments and trends in medical sciences, especially in the designated therapeutic area(s).
•Understand core scientific literature addressing clinical applications and safety of our products and be prepared to utilize this information in response to questions from internal and external customers, including Regulatory Authorities.
•Serve as a consultant to quality and pharmacovigilance functions in the investigation of adverse events and other product-related issues.
•Develop knowledge of regulatory, pharmacovigilance and quality assurance requirements in alignment with Baxter Global Business Practice Standards.
•Collaborate with Clinical Development and Operations in the development and writing of Clinical Trial Concept Sheets and Protocols as well as providing input to investigator's brochure and interim/final Clinical Study Reports (CSRs). Approve final clinical trial protocols, investigator's brochures and CSRs. Develop clinical sections of Regulatory submissions for CTAs and CTDs. The Medical Director has a worldwide scope and must comply with Good Clinical Practice (GCP) as practiced in different geographies.
Job Requirements
•Solid knowledge of GCP rules and regulations.
•Excellent leadership capabilities; teamwork oriented; interested in working in a multicultural and cross-functional environment.
•Strong management skills; decisive; resourceful.
•Well developed interpersonal skills; strong in providing education on complex scientific/clinical issues in a crisp and clear manner both to a peer and larger audience.
•Excellent verbal and written communication skills, public speaking and teaching skills.
•Strong Microsoft Office skills required
•Strong business acumen and impeccable integrity
•Maturity, confidence and credibility to advise and influence senior management.
Required Education and Experience include:
•MD degree, licensed physician who is Board Certified in Internal Medicine or equivalent training or experience. A solid understanding of fluid and electrolyte balance and the clinical use of IV fluids is highly desirable.
•Minimum of ten years of medical experience with five years of medical affairs/clinical development experience; or combination thereof. Experience in a biotechnology, pharmaceutical company or CRO performing most or all of the responsibilities in this position is preferred.
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
