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Clinical Research Manager OH Open (J#45414) Title: Clinical Research Manager Company: Boehringer Ingelheim Description Internal Posting Period: 8/19/11-8/26/11 Boehringer Ingelheim is currently seeking a talented and innovative Clinical Research Manager to join our Drug Regulatory Affairs-Medical Affairs department located at our Columbus, OH facility. As a Clinical Research Manager, you will be responsible for supporting the Medical team by managing various in vitro and in vivo studies required for filing new and on-going multisource ANDA products, and for working closely with the Product Development Team (PDT) on all issues surrounding the medical requirements and studies used to demonstrate bioequivalence. As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees. Duties & Responsibilities: - Participate as the medical PDT member for 4 to 5 new project starts every year. Ensure medical review for project is completed prior to PDT1 meeting and work with PDT to schedule, implement and complete all required in vitro and in vivo studies needed to support 16 to 18 ANDA filings. Work with PDT to provide medical input on formulation development and strategies. - Continue to monitor current CRO's and evaluate new analytical and clinical CRO's that can support Roxane Laboratories, Inc. (RLI) business. - Participate in FDA meetings regarding (A)NDA filings that RLI has in its pipeline. Grow technical expertise regarding PK, In-vitro, and medical studies for development of special products, such as inhalation, oncology and pediatrics. - Mentor Clinical Research Associates, student residents and other members of the medical group as appropriate. - Serve as the expert for projects to answer all medical and scientific-related questions and produce any required documents to support the development and lifecycle of products. Required Education & Experience: - Bachelor's degree in pharmaceutical or related sciences with a minimum of 6 years' relevant experience in conducting clinical studies; or Master's degree in pharmaceutical or related sciences with a minimum of 3 years' relevant experience in conducting clinical studies; or PhD or equivalent in pharmaceutical or related sciences with a minimum of 1 year of relevant experience in conducting clinical studies. - Up to 25% travel domestically (and to a lesser extent, internationally) will be required. Eligibility Requirements: - Must be legally authorized to work in the United States without restriction. - Must be willing to submit to a background investigation, including verification of your past employment, criminal history, and educational background - Must be willing to take a drug test and post-offer physical (if required) - Must be 18 years of age or older Desired Experience, Skills and Abilities: - Knowledge of phase I through phase IV development is strongly desired. - Experience in conducting studies for development of generic products is strongly preferred. - Strong written and oral communication skills. Ability to comprehend, analyze and interpret federal regulations in order to make them applicable for the business. - Ability to work independently and with minimum supervision in order to meet deadlines. - Ability to think outside the box, assess risk vs. benefit, and provide recommendations to senior management. - Ability to be a strong team player and to work closely with the PDT to provide robust medical input regarding medical strategies for current and prospective development products. - Strong scientific and regulatory knowledge of drug development. - 1-2 years of supervisory experience preferred. Boehringer Ingelheim is firmly committed to ensuring a safe, healthy, productive and efficient work environment for our employees, partners and customers. As part of that commitment, Boehringer Ingelheim conducts pre-employment background investigations and drug screenings. Boehringer Ingelheim is an equal opportunity employer. M/F/D/V

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