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Technical Writer V Technical Writer V
Ref No.: 18-13778
Location: Bridgewater, New Jersey
Title - Technical Writer V 
Location - Bridgewater NJ
Duration - 06+ Months 


Notes from Hiring manager:

This is a Clinical role and, per the released background requires the following:  Bachelor degree in a scientific/health-related field and 5 years of experience in the pharmaceutical industry, with 3 years of experience in clinical and/or quality operations-related roles (e.g., direct study management, monitoring, project management). Experience working within a global team/environment to produce operational reference standards to meet regulatory requirements across regions.
 
Someone with Clinical Trial experience who has written SOPs or other documents is acceptable. 


Interact with process improvement project teams and business representatives to review/clarify 'to be' processes and obtain additional information to finalize process maps (flowcharts).
Develop QDs (SOPs, Working Instructions and Supporting Documents – templates, checklists, etc.), using corporate templates and writing rules and according to international regulations and Good Clinical Practice ICH guidelines.
Manage QD review & approval process, follow up with business representatives and process owners, organize & chair review meetings.
Revise/update QDs according to decisions made by working group.
Peer QC of content of QDs. QC compliance of QDs against writing rules/templates and other regulations, links/references, macros and consistency across QD package.
Provide input into information letter
Status reporting & associated administration

Skills
Quality-focused with a high degree of personal accountability and commitment
Ability to analyze business processes, collect and review operational requirements/information
Excellent inter-personal skills, to communicate and collaborate efficiently with project teams, departmental associates, internal/external partners
Able to relate well to others at all levels throughout the organization, and work in an international team environment
Demonstrated ability to anticipate problems, changes, impacts, consequences, and delays; work proactively and take initiative for corrective measures
Ability to multi-task, handling a wide range of small, medium and long-term assignments in parallel and dealing with urgent issues as they arise; ability to prioritize assignments in accordance with assigned project deadlines
Excellent team leadership / facilitation skills : ability to lead effective cross-location and cross-functional meetings through discussions on complex and potentially controversial topics; ability to recognize issues that may require escalation to management level
Ideally, experience with process design (mapping) tools
Use of meeting management tools and systems, word processing software