Document Associate Job Description
Document associate
provides technical expertise for the development of clinical documents (protocols, monitoring plans, clinical trials report, investigator brochures, etc.) and trial conduct.
Document Associate Duties & Responsibilities
To write an effective document associate job description, begin by listing detailed duties, responsibilities and expectations. We have included document associate job description templates that you can modify and use.
Sample responsibilities for this position include:
Image (Scan) and Index (Data entry) documents according to various criteria Doc Type, Account Number, Firm and Workflow Path
Managing group mailboxes and actioning and responding to email requests for service
Pro-active behavior, with an ability to understand the nature of the business and priorities within the team
Ability to work autonomously using established procedures, seeking guidance where needed
Provide strategic direction for cross-sector medical safety document strategies and alignments with GMO, Janssen and sector(s) processes in support of organizational excellence that may be leveraged to support medical safety, CSA, and sector(s) goals and associated action plans
Ensure management of document related projects ensuring organizational compliance, successful outcomes with risk mitigation and intervention
Provide oversight of staff, as needed, responsible for facilitating development of procedural documents
Provide support to Cross-Pharma Council Co-Chair and Pharma Sector Standard Council GMO representative, support document development, dissemination of information and organizational compliance through gap assessments/impact assessments
Review and approve Training Project Plans and monitor and intervene/escalate as needed to best ensure on time deliverables
Ensure timely and accurate provision of Pharmacovigilance System Master File deliverables
Document Associate Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for Document Associate
List any licenses or certifications required by the position: MS
Education for Document Associate
Typically a job would require a certain level of education.
Employers hiring for the document associate job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and High School Degree in Education, Associates, Business, Science, Engineering, Management, Technical, Arts, Literature, Project Management
Skills for Document Associate
Desired skills for document associate include:
MS Office Suite
Adobe Acrobat Reader
Clinical trial processes
Completeness and Timeliness to ensure compliance and audit readiness
EMA and other guidance documents and policies related to clinical trials and clinical trial documentation
Enterprise claims systems
FDA
GCP/ICH
Loan documents
Microsoft Excel
Desired experience for document associate includes:
Contract management and vendor management skills
Proficient computer skills in Windows-based software products such as Word, Excel, Email, and PowerPoint
Tertiary qualifications in Library, Records and Information Management, or an information-related discipline and/or eligibility to professional associations
An understanding of Electronic Document Management Systems or Records Management systems
Knowledge of records management principles including issues relating to the management of business records in paper and electronic formats
Strong Microsoft Office experience, including intermediate Excel skill
Document Associate Examples
1
Document Associate Job Description
Job Description Example
Our innovative and growing company is looking for a document associate. We appreciate you taking the time to review the list of qualifications and to apply for the position. If you don’t fill all of the qualifications, you may still be considered depending on your level of experience.
Responsibilities for document associate
- Interface regularly with Training and Document Control and CAPA and Compliance Strategy management and colleagues to discuss status of projects, issues and documents
- Interface regularly with GMO staff members related to the development, review, approval or training of assigned controlled documents and document projects
- Review, edit and format controlled procedural documents of all levels of complexity and serves as liaison with document process owners and authors to ensure that development of documents occur according to established timelines, e.g Corrective Action/Preventative Action (CAPA) timelines
- Manage controlled documents in the EDMS including peer quality reviews
- Provide EDMS support to the organization as Business Administrators
- Lead and/or participate in procedural document initiatives and projects of moderate complexity
- Facilitates Cross-pharma Reviews and Impact Assessments as needed
- Provision of departmental metrics
- Provide Audits and Inspections support (including interview backup responsibilities) and litigation request support
- Facilitate Procedural Document Committee meetings
Qualifications for document associate
- Bachelor degree required preferably in business or health related field
- Management and supervisory experience is desirable
- A minimum of 5 years’ experience in procedural document lifecycle management is required
- Experience within the pharmaceutical industry is preferred
- Knowledge of Electronic Document Management System(s) is required
- Pharmacovigilance knowledge or experience is preferred
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Document Associate Job Description
Job Description Example
Our company is looking to fill the role of document associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for document associate
- Lead committee meetings and projects/initiatives professionally
- Foster consensus and make decisions independently appropriate to subject matter and responsibilities
- Monitor all document movement including both charts collected by UnitedHealthcare resources charts from vendors and movement to appropriate abstraction team or other vendor
- Create and maintain central location to archive manufacturing documentation
- Facilitate and catalogue manufacturing documentation deviations, investigations, CAPAs, manufacturing records and batchsheets
- Manage documents movement across all functional groups
- Prepare routine progress reports on manufacturing documentation for management
- Responsible for ensuring documentation timelines are met utilizing communication and follow through with document owners
- Monitor manufacturing training reports
- Act as contact person for scheduling utility shut downs and maintenance
Qualifications for document associate
- Knowledge of quality, compliance metric, and process excellence methodologies and analysis is preferred
- Ability to act in a consultative role to analyze document needs and ensure that required document outcomes are achieved is requiredPharmacovigilance
- Bachelor degree is required, preferably in business or a health related field
- Technical writing experience of a minimum of 4 years
- Advanced knowledge of Electronic Document Management System(s) is required
- Advanced knowledge of Microsoft Word, PowerPoint, Excel, and Visio
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Document Associate Job Description
Job Description Example
Our growing company is looking for a document associate. To join our growing team, please review the list of responsibilities and qualifications.
Responsibilities for document associate
- Respond to questions from other Operations departments, retail personnel and management staff
- Understand department procedures and required accountabilities so you can accurately process and analyze income account documentation
- Assist other Operations personnel with document related questions and other projects as needed
- Obtain Windchill token and upload released documents
- Copy released documents to a CD or DVD and mail or FED-X to NASA
- E-mail document delivery status to specified e-mail distribution
- Develop standard works for document transfer activities, identifying current and historical e-mail distributions, and logging documents transferred to NASA
- Maintain records of e-mail distributions and transferred documents
- Eventually back-up Principal Document Control Associate
- Is knowledgeable and complies with all pertinent safety
Qualifications for document associate
- A minimum of two years Print and Mail & Messenger, operations experience and knowledge of best practices in this area
- Experience with organizing multidisciplinary activities
- Knowledge in pharmaceutical safety-related areas preferredRegulatory Compliance
- Minimum of 1 year of experience processing drawings comparable to a Document Assistant 3
- Knowledge in pharmaceutical safety-related areas preferredPharmacovigilance
- Requires Associate’s Degree with 2+ years of related experience
4
Document Associate Job Description
Job Description Example
Our company is growing rapidly and is looking to fill the role of document associate. Thank you in advance for taking a look at the list of responsibilities and qualifications. We look forward to reviewing your resume.
Responsibilities for document associate
- Supply required information and assist in the preparation of the departmental budget
- Resolve Intra- and Interdepartmental and intra-company reporting issues, Regulatory, Operations
- Create/issue/maintain controlled forms, logs, lot numbers, work instructions, log books, document numbers, labels, (including but not limited to SOPs, protocols, methods, reports, batch records, specifications, drawings, validation plans, and maintenance logs)
- Update templates and work instructions when necessary
- Retrieve and respond to requests for information securely and in a timely manner
- Scan all controlled document records and maintain up-to-date and accurate metadata in EDMS-ready PDFs
- Assist Visual Production in the completion of all document preparation
- Work directly with the Visual Lab team and Lab Managers to anticipate photography needs and timelines
- Assist Visual Production with Photoshop and floorset document write-ups
- Manage and complete tasks by the given deadline
Qualifications for document associate
- Scan production records into an electronic format
- Archive documents, other filing duties as necessary
- Utilize Microsoft Access databases and Excel spreadsheets inputting data used for quality tracking
- Issue Device History Records and other production documents
- Enter change requests into Change Control Databases
- Other document projects as assigned by the department manager
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Document Associate Job Description
Job Description Example
Our innovative and growing company is hiring for a document associate. If you are looking for an exciting place to work, please take a look at the list of qualifications below.
Responsibilities for document associate
- Manage the creation/issuance of controlled forms, item numbers, batch records, DHFs, MHFs, log books, PM/CAL logs, document numbers, labels
- Directly supervise temps, interns, or contractors assisting with Doc Control or Technical Writing tasks
- Prepping documents by orienting, repairing and removing objects such as staples and paperclips from documents
- Create, maintain, and file commercial loans
- Communicate with Lenders, Private Client Groups, and Loan Administration team for pending information, documents, and original files
- Process monthly loan document exception report – follow up for pending documents
- Process and track Uniform Commercial Code financing statement (UCC1) filings
- Process commercial loan files for archiving
- Utilize the Records Management System (RMS) to manage hardcopy GMP documents submitted for retention and storage (both on-site and off-site)
- Processing and coordinating orders, receiving files, imaging files, image verification, delivery and shipping of documents
Qualifications for document associate
- Minimum requirement is a HS Diploma
- Act as a primary resource for advice for all document production needs of the Client (potentially forms, document design, replenishment stock) for both litho/web printing digital print solutions Production Print Advice and Services Promotion
- Manage Business Unit relationships, working with and advising Business Unit document owners to meet document production needs in a cost effective manner -- If applicable, become active member of the Clients Form Committee
- Ensure that savings targets are met and recorded for various deliverables, where applicable Print Job Management
- Provide system administration for the forms management solution implemented for the client Forms/Document Design
- Provide forms creation and revision services