Aditi Consulting · 5 hours ago
Technical Writer
Plainsboro, NJ
Contract
Onsite
Senior Level
$72/hr - $72/hr
7+ years expAditi Consulting is seeking a skilled Technical Writer/Procedure Document Specialist to enhance processes within the CMR Strategic Operations, GxP Compliance & Technical Operations. This role focuses on developing procedural documentation in a GxP environment, ensuring compliance and operational effectiveness while creating training materials and job aids.
AppsConsultingInformation TechnologySoftware Engineering
Responsibilities
Lead a multidisciplinary team of subject matter experts, business process owners, and key stakeholders in the development, revision, enhancement, implementation, and maintenance of process and procedural documentation
Plan and manage multiple process development projects simultaneously, ensuring timely delivery of targeted outcomes
Create and write content for training programs, including user-friendly training materials and job aids that support process understanding and application
Utilize your knowledge of global regulations within a GxP environment to create processes and related documentation that adhere to regulatory requirements, support corporate compliance, and are inspection-ready
Contribute to compliance and audit/inspection readiness strategies and plans, ensuring all documentation meets necessary standards
Evaluate global procedural documentation against evolving industry and regulatory requirements, audit/inspection findings, and corporate policies; recommend changes as necessary based on feedback, trends, and best practices
Qualification
Required
Education: Minimum of a BA or BS required; an advanced degree in a relevant field is desirable. Degree or professional certification in process design or change management is a plus
Minimum 7+ years of experience in the design and documentation of pharmaceutical business processes and change management required
GxP environment experience required; pharmacovigilance (PV) experience preferred
Technical Writing: Background in pharmaceutical technical writing and development of Standard Operating Procedures (SOPs) is essential
Organizational Skills: Strong organizational abilities, planning, and multitasking skills; capable of prioritizing multiple projects while meeting tight deadlines
Adaptability: Ability to work effectively under pressure and adapt to changing situations with attention to detail
Technical Proficiency: Proficient in common desktop tools, including MS Word, MS Excel, MS Project, and Visio and PowerPoint
Communication Skills: Strong verbal and written communication skills with an in-depth understanding of pharmaceutical business processes, regulations, guidelines, and industry standards relating to compliance
Preferred
Experience in process training development, delivery, and/or implementation is preferred, including the creation of training content and job aids
Project Management Skills: Proven ability to manage multiple projects simultaneously; PMP certification is an advantage
Experience in a GxP environment; PV experience preferred
Strong project management skills with a proven ability to manage multiple projects simultaneously; PMP certification a plus
Ability to create training materials and job aids that facilitate process understanding and implementation
Proficiency in using Visio for process mapping and diagram creation
Ability to work on critical initiatives under pressure while maintaining a keen attention to detail
Benefits
Medical, dental, and vision benefits
Health savings accounts with qualified medical plan enrollment
10 paid days off
3 days paid bereavement leave
401(k) plan participation with employer match
Life and disability insurance
Commuter benefits
Dependent care flexible spending account
Accident insurance
Critical illness insurance
Hospital indemnity insurance
Accommodations and reimbursement for work travel
Discretionary performance or recognition bonus
Sick leave
Mobile phone reimbursement provided based on state or local law
Company
Aditi Consulting
Aditi Consulting is a firm that stays abreast of offering technological solutions, project management and digital transformation.
1001-5000 employees
H1B Sponsorship
Aditi Consulting 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 (55)
2024 (44)
2023 (25)
2022 (26)
2021 (24)
2020 (30)
Funding
Current Stage
Late StageLeadership Team
Raja Narayana
President & CEO
Pradeep Singh
Chairman
Recent News
bloomberglaw.com
2025-10-16
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