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Clinical Data Coordinator OH Open (J#40040) Internal Posting Period: 8/16/2010-8/20/2010. Boehringer Ingelheim is currently seeking a talented and innovative Analyst III,Drug Regulatory Affairs to join our business operations located at our Columbus, OH facility. As an Analyst III,Drug Regulatory Affairs employee, you will support both their individual and overall departmental goals regarding the number of ANDAs to be filed and approved yearly by planning, managing, compiling, and assuring the quality of Abbreviated New Drug Applications (ANDAs) that are filed on time and responding to subsequent deficiencies completely and on time. You will mentor and provide regulatory support to other analyts within the group. 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. Responsibilities: Prepares and submits Annual Reports to the FDA. Review, assess, and approve all regulatory documents to ensure decisions are made using regulatory knowledge and FDA guidance documents. Works with other departments and teams to obtain the appropriate documents. Writes, analyzes and submits Abbreviated New Drug Applications (ANDA's) or New Drug Applications (NDAs) to the FDA. Works directly with the FDA to resolve issues generated during submissions. This includes educating other departments on requirements/documents needed. Analyze information and provide regulatory interpretation to RLI and BIRI groups. Utilize critical thinking skills to review technical reports and other documentation for compliance, scientific accuracy and consistency to support ANDA and NDA filings. Manages multiple projects both new and lifecycle with minimal supervision. Evaluates processes and works towards Right First Time objectives by demonstrating leadership skills. Provides mentoring and regulatory support to Analysts I and II in order to help drive the business and increase their exposure. Attends educational courses and seminars and brings knowledge back to group. All other duties as assigned. 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 Requirements: Bachelors degree required in a Science related field. Ms in Pharmacy, pharmacology, Biochemistry, Chemistry and/or Regulatory preferred. A minimum of five (5) years of Pharmaceutical industry experience preferably in a regulatory environment. Excellent oral communication skills required to present information as well as facilitate group meetings. Excellent written communication skills. Ability to manage projects with minimal supervision. Demonstrated project management skills and the ability to negotiate positive outcomes. Ability to interact effectively across levels of the corporation. Ability to multitask, plan, organize, and coordinate tasks. Ability to analyze scientific data, recognize issues or potential barriers, and bring to resolution. Ability to participate effectively in teamwork environment. Demonstrate attention to detail with emphasis on accuracy and right the first time. Demonstrated leadership skill to mentor junior analysts.

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