Contract Technical Writer
Data Management
US - Home or Office Based

Technical Writer is responsible for supporting key activities within Data Management that are related to the writing of controlled and internal documentation; defining, creating and documenting business processes; and generating training and learning content.
General Technical Writer responsibilities:
  • Work with Data Management and cross-functional SMEs to generate standard operating procedures, job aids and other types of controlled documentation to support required Data Management functions while adhering to the current global regulatory regulations, guidelines and best practices
  • Provide technical writing assistance with documents to ensure quality, compliance and consistency of writing
Specific responsibilities:
Process Mapping:
  • Work with Data Management and cross-functional SMEs to generate process maps that document work processes
  • Work with teams to create supplemental information to support use of process maps
Learning Content:
  • Work with Data Management SMEs to identify audience, establish training requirements and generate interactive training materials on required topics
  • Maintain all suites of documents on SharePoint in an organized manner
Qualifications and Experience:
  • Minimum Education:
    • Bachelor degree is required
  • Minimum Work Requirements:
    • 5+ years relevant work experience in pharmaceuticals, biotech, CRO or related field
  • Skills:
    • Strong organizational and project management skills
    • Ability to work independently
    • Ability to multitask in a fast-paced environment
    • Strong interpersonal, communication, diplomacy, and presentation skills
    • Proficient in Microsoft Office suite of applications
    • Ability to create and manage content on SharePoint, including functional sites and databases
    • Demonstrated attention to detail
    • Knowledge of pharmaceutical regulations and requirements (ie, cGCP)
    • Experience writing controlled documents and generating learning content
    • Experience leading process mapping and process improvement activities
    • Ability to identify and recommend ways to streamline work processes
    • Ability to establish effective business relationships
    • Solid understanding of Data Management principles such as study initiation, maintenance and close-out, database build, implementation, and lock, SAS development, coding dictionaries, data querying and cleaning, blinding/unblinding, and archival are all preferred.
Cytel Inc. is an Equal Employment / Affirmative Action Employer. Applicants are considered for all positions without regard to race, color, religion, sex, national origin, age, veteran status, disability, sexual orientation, gender identity or expression, or any other characteristics protected by law

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