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Records Management III
Ref No.: 18-13584
Location: Pearl River, New York
Job Description: Pay rate: $25.00

• Support submission ready process and records management program for the Department.
• Responsible for preparing and assuring documentation associated with regulatory submission meets current regulatory specifications
• Support colleagues on use of submission templates, act as subject matter expert for current submission guidelines and any documentation needs.

• Partnering with project teams and other customer groups (e.g., Managers, Cross functional teams, etc.) to ensure required regulatory contributions (briefing documents, IND, NDA, MAA, etc.) meet business needs and are provided in accordance with agreed time and quality standards.
• Accountable for database searches and contribute to documentation workflows.

• Strong IT skills: advanced use of MS Word, Adobe Acrobat. Knowledge of Documentum system
• Minimum 5 years of experience, knowledge and awareness of the functioning of the pharmaceutical industry (vaccine research and/or regulatory environment preferred)
• Ability to understand complex issues with appropriate support, such as global and/or regional regulatory activities involved in the regulatory filing process
• Strong written and verbal communication skills. Ability to work well with appropriate level of independence, appropriate level of supervision, and scientific and regulatory community.
• Strong problem solving skills, organizational skills, and multiple projects flexibility. Ability to work well with the team.
• Detail oriented, precise in oral and written communication. Must be able to present information effectively, both orally and/or in writing, in a concise, logical, and persuasive manner.
• Work well under pressure and a demanding workload.
Position Comments visible to MSP and Supplier: ***Please provide reference checks up front during submission! attach where resume goes ***