Assisting in maintaining the corporate Electronic Document Management System (EDMS) by:
Creating, deleting and updating user accounts to reflect personnel changes including role assignments.
Assisting global end-user support both remotely and in-person for basic EDMS trouble-shooting such as lockouts and user credential verifications.
Providing basic EDMS training and guidance to staff regarding the use of the system.
Assisting in EDMS integration activity by revising documentation, courses, users, roles, grandfathering and basic EDMS activity as necessary.
Updating and maintaining document tracking such as Table of Contents and SharePoint sites based on relevant documentation.
Revising and creating controlled documentation and placing into appropriate templates according to the SOP on Controlled documents.
Collaborating with authors on documents, attachments, forms and templates that are out-of-compliance or in need of revision.
Identifying opportunities for document Retirement, preparing the Document Retirement Form and obtain signatures. Archiving document in the EDMS and other tracking mechanisms.
Preparing and assisting in audits by providing requested information, producing and interpreting reports as required, and providing administrative support.
Identifying opportunities to improve the end-user experience for EDMS and Document Management procedures
Maintain quality service and departmental standards by
Reading, understanding, and adhering to organizational standard operating procedures (SOPs)
Assisting in establishing and enforcing departmental standards
Contribute to team effort by
Working with internal staff to resolve issues
Exploring new opportunities to add value to organization and departmental processes
Helping others to achieve results
Performing other duties as assigned
Maintain technical and industry knowledge by
Attending and participating in applicable company-sponsored training
High School Graduate or Associate/Bachelor's Degree in bioscience,computer science, information technology or related field preferred
Bachelors degree preferred
1+ years experience working with an electronic document management system (EDMS)
Working knowledge of GCP, ICH guidelines and FDA regulations.
Intermediate to advanced knowledge of Microsoft Office and SharePoint preferred
Ability to prioritize requirements and delegate tasks to meet goals
Excellent organization and time management skills are required to manage multiple projects simultaneously
Able to work independently and provide support to others
Self-motivated, flexible and adaptable to business needs.
Strong motivational skills and abilities, promoting a team-based approach
Strong interpersonal and communication skills, both verbal and written
Strong organizational and leadership skills
Ability to maintain professional and positive attitude
Founded in 2006, Synowledge specializes in providing drug safety, regulatory affairs and... related IT services to small, mid, and large sized pharmaceutical, biotechnology and medical device companies. We are headquartered in Stamford CT, USA with operational facilities across the United Kingdom, Columbus, Ohio, and Bangalore, India. Our comprehensive outsourcing solutions combine the unique strengths of both onshore and offshore services to meet all of our clients’ pressing needs.
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