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Technical Writer, Data Management

Company:
Artech Information Systems
Location:
Cambridge, Massachusetts, United States
Posted:
February 20, 2018
Description:

Description:

Job Description:

Job Title: Technical Writer, Data Management

Job ID: BIIBJP00009413

Location: Cambridge, MA

Duration: 6 Months

Description:

Technical Writer is responsible for supporting key activities within Data Management that are related to the writing of controlled and internal documentation, defining and creating business processes, and generating training and learning content.

Principal Accountabilities

1. Technical Writing:

• 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

2. 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

3. Learning Content:

• Work with Data Management SMEs to identify audience, establish training requirements and generate interactive training materials on required topics

4. SharePoint:

• Maintain all suites of documents on SharePoint in an organized manner

Requirements

• Bachelor’s degree required

• 5+ years relevant work experience in pharmaceuticals, biotech, CRO or related field

• 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

• 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 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