Project Manager Documents Control Specialist
The Documents Control Specialist reports directly to the Document Controls Manager and supports all processes of the administered plan for controlled documents within the company. Must be Cultural and Linguistic competent, Bilingual a plus; Haitian Creole, Portuguese Creole, Spanish, Vietnamese, Chinese or Cambodian
POSITION RESPONSIBILITIES AND TASKS:
- Work with project teams in migration meetings and meetings to upload their project documentation
- Assist and support Editing and project management
- Draft correspondence, agreements, contracts, and other documentation for varied business associates
- Coordinate the external review of product proposals and product content
- Enter and maintain project status information in a project tracking system; drafting various project reports and documents
- Prepare for and attend interdepartmental process meetings
- Create subsites in SharePoint for restricted teamwork and projects
- Develop special interest sites such as Lessons Learned and work closely with those teams to meet their requirements
- Assist in identifying gaps in workflows by interviewing and working closely with all users
- Help to enhance plans to migrate files to new systems.
- Support and help to document all processes and procedures
- Participate in regular reviews of established procedures
- Assist in enforcing document control requirements and rules for standards
- Perform system administration tasks if and when required
- Participate in training programs and workshops for all users including one-on-one sessions as needed
- Assist in gathering required data for reporting status on the system
- Work with Project Management procedures to test and evaluate the system
- Know and improve processes to help ensure archiving of regulatory documents in a central repository and required access and distribution as needed
- Assist in the development of standards when/where applicable
- Must have excellent strong oral and written communication skills
- Assist with Management of the Document Control System including:
- Maintaining all internal documents in the database – configuration, routing, and the release of documents.
- Maintenance of the Master database.
- Enter Documents into Master Control, as required.
- Assist users and provide training when necessary.
- Maintain control of all external documentation/records and documents not maintained in a database
- Assist the QA department to meet regulatory and compliance requirements.
- Must be highly motivated and self-directed.
- Demonstrated ability to work within a team and to work independently
- Must have a home office (computer, fax machine, email address and cell phone)
- Attend required trainings and staff meetings
- Must be computer literate. Detailed and organizational skills critical
- Must meet state criminal background check requirements
- Pass CORI & SORI
KEY SKILLS & BEHAVIOR:
- Documentation control: 5 years (Preferred)
- Medical Industry: 2 years (Required)
- Experience working in a fast-paced environment;
- Good verbal, written and interpersonal communication skills.
- Knowledge of document control policies and practices.
- Ability to learn new software/systems quickly
- Excellent computer skills (Familiarity with many various software and file formats -Microsoft Office Suite, Acrobat and database management
- Highly adaptable
- Detailed oriented and enjoys troubleshooting and problem solving
- Be able to process ideas quickly
- Take direction well
- Work well within a team
- Have an outstanding work ethic.
Location: Randolph, Massachusetts
Job Type: Full-time
Age group: All ages
QUALIFICATION REQUIRED AND EXPERIENCE:
- Assist with large and small research projects and collects data, tracks and maintains as resources as directed
- Four years minimum of broad documentation and/or document controls, information management experience
- Bachelors degree is preferred but not required
- Understanding of ECM (Electronic Content Management) systems such as SharePoint, Documentum, FileNet, McLaren, etc. Internal Audits Procedures
- Experience in working closely with IT areas
- Desirable Background experience – IT, Electronic Publishing, Pharma document control – knowledge of all file formats, graphics and many different software programs
- Any project management experience and/or knowledge are desirable.