Collabera · 2 days ago
Technical Writer/Procedure Document Specialist IV
Plainsboro, NJ
Contract
Onsite
Senior Level
$65/hr - $70/hr
7+ years expCollabera is a company focused on providing workforce solutions, and they are seeking a Technical Writer/Procedure Document Specialist IV. The role involves authoring and managing GxP-compliant documentation while collaborating with various teams to ensure compliance and quality in documentation processes.
ConsultingInformation ServicesInformation Technology
Hiring Manager
Sakshi Malviya
Responsibilities
Prior experience in pharma or biotech environments
Understanding of regulatory standards and compliance expectations
Hands-on experience authoring, reviewing, and managing GxP-compliant documentation
Familiarity with cGMP, GLP, GCP and other relevant quality frameworks
Pharmacovigilance (PV) experience preferred
Strong background in writing, editing, and maintaining Standard Operating Procedures (SOPs)
Ability to work across multiple functional areas (QA, Clinical, and Patient Safety teams) to align documentation with business and compliance requirements
Understanding of best practices in SOP creation and maintenance
Excellent writing, documentation, and communication skills
Ability to translate complex processes into clear, compliant documentation
Experience collaborating with multiple stakeholders and SMEs
Proficiency in MS Visio (for process mapping and diagram creation)
Strong skills in Word and PowerPoint
Familiarity with AI tools, including ChatGPT, for improving efficiency and document quality
Strong process-oriented mindset - able to structure and streamline documentation processes
Excellent communicator with the ability to collaborate across departments
Detail-oriented and highly organized; ensures accuracy and compliance in all deliverables
Qualification
Required
Bachelor's degree (BA/BS required)
7+ years of professional experience, preferably in the pharmaceutical industry
Prior experience in pharma or biotech environments
Understanding of regulatory standards and compliance expectations
Hands-on experience authoring, reviewing, and managing GxP-compliant documentation
Familiarity with cGMP, GLP, GCP and other relevant quality frameworks
Strong background in writing, editing, and maintaining Standard Operating Procedures (SOPs)
Ability to work across multiple functional areas (QA, Clinical, and Patient Safety teams) to align documentation with business and compliance requirements
Understanding of best practices in SOP creation and maintenance
Excellent writing, documentation, and communication skills
Ability to translate complex processes into clear, compliant documentation
Experience collaborating with multiple stakeholders and SMEs
Proficiency in MS Visio (for process mapping and diagram creation)
Strong skills in Word and PowerPoint
Familiarity with AI tools, including ChatGPT, for improving efficiency and document quality
Strong process-oriented mindset - able to structure and streamline documentation processes
Excellent communicator with the ability to collaborate across departments
Detail-oriented and highly organized; ensures accuracy and compliance in all deliverables
Preferred
Pharmacovigilance (PV) experience preferred
Benefits
Medical insurance
Dental insurance
Vision insurance
401(k) retirement plan
Life insurance
Long-term disability insurance
Short-term disability insurance
Paid parking/public transportation
Paid time off
Days/hours of paid sick and safe time
Days/hours of paid vacation time
Weeks of paid parental leave
Paid holidays annually
Any additional benefits applicable
Company
Collabera
Collabera is an end-to-end information technology services and solutions provider helping clients align their business and IT strategies.
10001+ employees
H1B Sponsorship
Collabera has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (141)
2024 (93)
2023 (120)
2022 (186)
2021 (180)
2020 (146)
Funding
Current Stage
Late StageTotal Funding
$30M2006-05-04Series Unknown· $30M
Leadership Team
Lalit Sharma
CFO
Michael H. Abraham
Chief Financial Officer
Recent News
2026-02-06
2024-04-09
2023-01-20
Company data provided by crunchbase