Clinical Technical Writer
5+ years
Nutley, NJ
Contract
Onsite
1 month ago
About the role
Job Title: Clinical Technical Writer
Location: Nutley, NJ (Hybrid)
Duration: 06+ Months
Position Overview:
We are seeking an experienced Clinical SOP Writer to support the development, revision, and quality review of clinical procedures and documentation within a pharmaceutical environment. This role will collaborate closely with Process Owners, Subject Matter Experts (SMEs), and key stakeholders to create clear, compliant, and standardized SOPs, forms, and templates aligned with organizational writing standards and regulatory requirements.
Key Responsibilities:
Required Qualifications:
Preferred Skills:
Location: Nutley, NJ (Hybrid)
Duration: 06+ Months
Position Overview:
We are seeking an experienced Clinical SOP Writer to support the development, revision, and quality review of clinical procedures and documentation within a pharmaceutical environment. This role will collaborate closely with Process Owners, Subject Matter Experts (SMEs), and key stakeholders to create clear, compliant, and standardized SOPs, forms, and templates aligned with organizational writing standards and regulatory requirements.
Key Responsibilities:
- Develop, revise, and maintain clinical Standard Operating Procedures (SOPs), forms, and templates
- Partner with Process Owners, SMEs, and stakeholders to gather process requirements and ensure document accuracy
- Ensure all documentation aligns with company writing style guidelines and clinical documentation standards
- Perform quality control reviews of clinical procedures to ensure consistency, compliance, and clarity
- Support process documentation initiatives across multiple clinical development functions
- Maintain document version control and support procedural updates as needed
Required Qualifications:
- Bachelor’s degree in English, Communications, Life Sciences, or a related field
- Strong professional writing, editing, and document quality review experience
- Experience working cross-functionally in clinical development within the pharmaceutical industry
- Solid understanding of the drug development lifecycle and clinical trial processes
- Working knowledge of compliance standards, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use guidelines, Good Clinical Practice, and regulatory requirements
- Proficiency in Microsoft Word and Microsoft Excel
- Strong project management, multitasking, and stakeholder communication skills
- Excellent written and verbal communication abilities
Preferred Skills:
- Experience applying writing style guides and document standardization practices
- Ability to manage multiple document projects in a fast-paced clinical environment
- Strong attention to detail with a focus on compliance and quality documentation
Skills
Writing/Editing