Fresenius Kabi USA, LLC

Additionally, the Senior Director is responsible for directing the strategy for the Medical Science Liaison team and other members of the HQ PN Medical Affairs to ensure appropriate evidence generation and communication plans with healthcare professionals.. Work with the Global and US regulatory & commercial team to support pipeline advancement, on-market strategy/execution and FDA approval and post marketing commitments for parenteral nutrition (PN) products, providing medical / scientific support.. Lead team to support medical content development and review of all parenteral nutrition communication tools including marketing/promotional tools (MRL), medical/clinical inquiries, and scientific dossiers to support safe and appropriate product use.. MD, RD, RPh, PhD, PharmD, or RN degree required.. Knowledge of applicable regulatory, legal and compliance standards.

director medical affairs

Job Summary The Senior Director, Medical Affairs, Parenteral Nutrition (PN) is a critical role as this individual serves as the lead for the US PN Medical Affairs team and is responsible for developing and executing the US Medical Affairs strategy. This individual also collaborates closely with the Global business unit (BU) and the regional marketing organization to identify US nutrition insights and clinical nutrition opportunities to help advance the business. Additionally, the Senior Director is responsible for directing the strategy for the Medical Science Liaison team and other members of the HQ PN Medical Affairs to ensure appropriate evidence generation and communication plans with healthcare professionals.Responsibilities <ul><li>Work with the Global and US regulatory & commercial team to support pipeline advancement, on-market strategy/execution and FDA approval and post marketing commitments for parenteral nutrition (PN) products, providing medical / scientific support. </li><li>Mentor, manage, and ensure development of the PN Medical Affairs Team. </li><li>Lead team to support medical content development and review of all parenteral nutrition communication tools including marketing/promotional tools (MRL), medical/clinical inquiries, and scientific dossiers to support safe and appropriate product use. </li><li>Lead field (MSLs) and HQ team to ensure complaint and effective healthcare professional interaction and communication of appropriate and safe product use. </li><li>Support US clinical nutrition post marketing commitments including clinical study protocol development and review, study execution, and study report development. Evaluate IIT support requests per medical strategy alignment and scientific merit. </li><li>Lead field and HQ team to manage strategy, develop targets, and process for US Key Opinion Leader and HCP scientific exchange in PN. </li><li>Create and manage Medical Education program to support internal and external training needs for PN. </li><li>US Medical Affairs Parenteral Nutrition representative to Global Medical Committee. </li><li>Be accountable for the department budget, forecasts, and provide accurate estimates and accruals. </li> </ul>Job Requirements <ul><li>MD, RD, RPh, PhD, PharmD, or RN degree required. </li><li>12+ years of related experience required (clinical and/or industry experience; expertise in PN and/or EN highly preferred). </li><li>5+ years pharmaceutical industry experience required. </li><li>5+ years of Medical Affairs experience required. </li><li>7+ years of management experience and demonstrated leadership. </li><li>Experience leading field teams (e.g., MSLs) strongly preferred. </li><li>Demonstrated skill in writing scientific documents. </li><li>Knowledge of clinical trial design and process. </li><li>Knowledge of applicable regulatory, legal and compliance standards. </li><li>Position will require 30% travel, including overnight stays. </li> </ul>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. #J-18808-Ljbffr

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