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Records Management III
Ref No.: 18-12627
Location: Pearl River, New York
Start Date / End Date: 10/29/2018 to 10/28/2020
Contractor Work Location: Pearl River - NY
Job Title: Records Management III
Shift: Other (08:00 AM - 04:30 PM)
Duration: 104 W, 3 D

Candidate must complete a MS word proficiency test

Job Description:

ROLE SUMMARY:
• Support submission ready process and records management program for the Department.
• Responsible for formatting and assuring documentation associated with regulatory submission meets current regulatory specifications.
Provide advanced word processing support for documents included in submissions. This requires a highly competent knowledge of word processing (e.g. MSWord) and publishing (Adobe Acrobat) applications.
• Support colleagues on use of submission templates, act as subject matter expert for current submission guidelines and any documentation needs.

ROLE RESPONSIBILITIES:
• Partnering with project teams and other customer groups (e.g., Managers, Cross functional teams, etc.) to provide advanced word processing support for documents included in submissions to ensure required regulatory meet business needs and are provided in accordance with agreed time and quality standards.
• Accountable for database searches and contribute to documentation workflows.

QUALIFICATIONS:
• 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.

Support Submission Documents for on-going VRU Licensure Projects to FDA & other agencies including but exclusively: CDiff, GBS, RSV, PNG.
Additional Skills: 2 year assignment
onsite in Pearl River
self motivator, HM is not onsite so work independent on documents but collaborate with team and check in with HM. Personable, professional, good communicator.
Must have records management experience, Pharma experience, Regulatory documention and regulatory submissions.
Date review, strong computer skills, strong word skills and some excel.
Attention to detail
flexible on education, NO PhD, experience is key
training provided and work up and take on more projects
collaborate with other team.
word processing support, data review


top skills:
Pharma experience
Regulatory documents
Attention to detail
Will overtime be needed?: Yes
If Yes, how many hours of overtime (on average) per week?: 1-2 hrs. per week
non-exempt
What is the minimum education experience required?: 2 Yrs. if College degree or 5 Yrs. Experience with no college degree