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The Scientist I, Analytical Development demonstrates success in technical proficiency, scientific creativity, collaboration with others and independent thought. As a key member of the Analytical Development group provide analytical support for process development group and manufacturing.
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With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people.
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QUALIFICATIONS A scientific degree with directly relevant professional experience in small molecule development, global CMC regulatory affairs and CMC technical areas of at least 16 years with a BA/BS or 14 years with an MA/MS, PhD, PharmD, or MD. Demonstrated track record in leading CMC regulatory affairs initiatives, innovative CMC regulatory strategies, and leadership in international regulatory/industry forums for topics of external policy relevance (e.g., ICH, PhRMA, ISPE, IQ, Bios, etc.
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The CS supports the CPL and CSL in the development of the Clinical Development Plan and associated clinical trial content (e.g., protocols, IBs/IDFUs, CRFs, CSRs, regulatory submissions and publications) by contributing to scientific/clinical information aligned with the strategy.
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Apply principles of biology, chemistry and other scientific fields to the development and execution of process characterization and investigation studies. Analyze data using a combination of statistics, scientific principles and other techniques to gain insights into manufacturing process performance and control.
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The Associate Director Regulatory Affairs, Strategic Global Labeling, combines the knowledge of scientific, regulatory, and business issues to enable products that are developed, manufactured, or distributed to meet required legislation.
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By employing a worldwide certification process that’s backed by scientific research and testing, and over a century of experience. The position is eligible to participate in FM Global’s comprehensive Total Rewards program that includes an incentive plan, generous health and well-being programs, a 401(k) and pension plan, career development opportunities, tuition reimbursement, flexible work, time off allowances and much more.
$63,700 - $91,700 a yearExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
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Collaborate with multi-functional teams (i.e. Manufacturing, Process Development, Quality, Supply Chain, Maintenance, Device Engineering, Primary Container Engineering, Artwork/Labeling, Regulatory, etc.
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Provide mentorship/guidance, support, and feedback to junior medical team members, copywriters, and freelance contract writers as needed during the content development process. The Medical Director participates as a department representative at internal functions requiring scientific input, participates in strategy and scientific/medical components of new-business development activities, represents the company at client meetings at which scientific expertise is needed for the planning or acquisition of future projects, and interacts with clients, faculty, key clinical experts, and patients in support of pharmaceutical advertising/promotional initiatives.
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Evaluation Methodologies, plus at least 4 months of hands-on experience in research projects involving macroeconomic and monetary policies and provided development of data analytical skills and the efficient use of electronic and traditional research and data analytical tools such as STATA.
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Leads advanced, practical applications of scientific theory and exceptionally complex processes in the development and ongoing technical management of the unit's products; influences technology development across the company.
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Collaborate with cross-functional teams, including product development and operations to develop and implement new manufacturing processes for production by conducting feasibility studies, designing process flows, implementing scientific molding principles, optimizing cycle times, and ensuring product quality and consistency.
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Utilize tools such as lean manufacturing, Six Sigma, and Kizan to identify and implement process enhancements, cost-saving measures, and waste reduction strategies and measure the impact of process enhancements across the Division.
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Sound technical knowledge of Animal Health Medicine Associate Field Manager, familiar with Animal health sales process and related scientific knowledge. Development of good rapport with Milk union and other NGO.
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Knowledge of the drug discovery and development process, clinical trial methodology, worldwide regulatory requirements and the pharmaceutical/biotech industry. Serving as a scientific communications and publications ambassador to the cross-functional team and business partners and ensuring production and adoption of publications and communication platforms, that best position McKesson as a thought leader in the space.
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