Documentation Associate

  • location: Cambridge, MA
  • type: Temporary
  • salary: $28 - $31 per hour
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job description

Documentation Associate

Documetation Associate 1 at Biotech/Phama Cambridge, MA
Position Title: Documentation Associate I
Function: Vaccine Business Division (VBD)
Department: Clinical Serology
Reports To: Associate Director, Serology Project Management
contract: One year
Responsibilities:
OBJECTIVES:
??? Logistical and operational aspects of submission preparation and related activities (up to 80%), including preparing documents for review, document formatting and managing documentation in Document Management System, as well as archiving submissions and regulatory correspondence.
??? Provide administrative office support (20%) to Regulatory Affairs Vaccines, including calendar management, processing expense reports, managing purchase orders, coordinating travel arrangements for domestic and international meetings and conferences, hosting visitors, and coordinating meetings.
??? Proactively manage operational aspects of submission schedules/timelines to guarantee established deadlines are met.
??? Independently manage document work flows based on submission plan.
??? Format submission documents as required in accordance with standard styles.
??? Prepare submission-ready PDF documents in accordance with standards.
??? Maintain paper and electronic archive files for regulatory submissions and correspondence. Ensure submission components are properly classified, indexed and submission records are complete.
??? Process archive requests within established timeframe.
??? Lead or assist with administrative and non-submission related projects and activities (appropriate for this job level) as assigned by management, in support of the Global Regulatory Operations and Compliance function.
Working hours: 8:30 PM - 5:30 PM
Skills:
ACCOUNTABILITIES
--Candidate must have strong, documented technical experience or aptitude; Ability to quickly learn new software tools and systems to support job function.
--Experience with MS Word, MS Excel, MS Powerpoint, MS Outlook and Adobe Acrobat required.
--Experience with electronic document management software (Documentum) is stongly preferred.
--Must be able to work independently and take ownership of assigned tasks and projects.
--Must possess good analytical and problem-solving skills
--Must be able to follow regulatory guidance and understand industry standards
--Must have excellent communication skills and the ability interact with people at various levels of the organization.
--Candidate will be capable of balancing submission support with administrative tasks and long-term projects.
--Must be comfortable in a high-visibility, fast-paced environment.
--Exceptional attention to detail and ability to perform routine tasks with care and attention.
--Exposure to electronic publishing preferred.
Qualifications:
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:
??? BS/BA Degree or relevant equivalent experience.
??? 2 years experience in document management and/or electronic publishing.
??? Requires strong attention to detail in document preparation, proofing own work, understanding priorities and meeting deadlines.
??? Proficiency working in Windows environment and with Windows-based desktop productivity applications. Experience in MS Word, MS Excel, MS Powerpoint, and MS Outlook required. Experience in Adobe Acrobat, MS Visio, and DMS experience preferred.
??? Demonstrates problem-solving ability, flexibility and teamwork.
??? Excellent written and oral communication skills. Must be able to interact and communicate with individuals at all levels of the organization.
??? Must have strong organizational skills.
??? Ability to work successfully within a cross-functional team.
??? Must be able to work in a fast paced environment with demonstrated ability to juggle multiple competing tasks and demands.
??? Must be self-motivated and able to anticipate departmental needs.
Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Sexual Orientation, Gender Identity, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law.
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