Reporting to the Associate Director North America, the incumbent provides support to new product registrations in Merial. Implements procedures to ensure integrity of Merial research output intended for regulatory submission. The incumbent is expected to support QA management in specific areas relative to the R&D and regulatory functions and/or processes. The incumbent will be expected to prepare, track and implement quality documents and processes.
Major responsibilities include, but are not limitied to, the following:
Confer with R&D Leaders and/or clinical management regarding quality or regulatory practices or issues relative to pre-clinical and clinical studies and work with the customers to develop corrective and/or preventive action plans.
Develops processes, train and facilitate subsequent process documentation with functional R&D departments.
Ensure Pharmacovigilance (PV) data and reports are compliant to regulatory directives and data integrity is executed sufficiently for regulatory scrutiny.
Prepare, track and conduct training (study specific, GXP) to support all functional groups within and outside our organization in various areas of compliance and expertise.
Conduct mentoring for new or less experienced auditors relative to the auditing of analytical data, statistical data and pre-clinical/clinical data and reports and PV data and reports.
Identify opportunities for internal/external improvements within R&D and aid in the implementation.
May direct the activities of one or more QA auditors and/or consultants.
To all recruitment firms: Merial does not accept agency/search firm referrals for this posting, or other postings, without prior written permission from Merial Human Resources. Merial is not responsible for any fees related to unsolicited resumes.
Due to tracking regulations, only resumes submitted directly via OneMERIAL for internal employees, and Merial.com/Careers for external applicants, can be considered.
Equal Opportunity Employer M/F/D/V
The incumbent must have BS or BA Degree in the Sciences and minimum of 6 years demonstrated experience in conducting regulatory and quality audits and training in the pharmaceutical industry. Must possess detailed awareness through experience and knowledge of Merial standards and their practical application covering a broad range of examples. Knowledge of EPA, FDA (CVM), EMA and supportive guidelines/regulations that apply, i.e. VICH No. 85 GL9, Good Clinical Practice, OECD GLP, 21 CFR Part 58, 40 CFR Part 160 and PV regulations and guidelines and expertise of their practical application in R&D processes is required. Knowledge of Pharmacovigilance reporting processes in both US and EU and the QA processes associated Pharmacovigilance reporting. Ability to communicate effectively and autonomously with a wide variety of external/internal customers as well as ability to work proactively in a project or team environment. Proficiency in MS Word, Power Point, SAS, Path Data and Advanced Excel software required.
Merial is a world-leading, innovation-driven animal health company, providing a comprehensive range of products to enhance the health, well-being and performance of a wide range of animals. Merial employs approximately 5,600 people and operates in more than 150 countries worldwide. Its 2011 sales were more than $2.8 billion. Merial is a Sanofi company. For more information, please see www.merial.com.
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