Position Details:

Job Title: Technical Writer/Procedure Document Specialist IV

Location: Plainsboro NJ

Duration: 12 Months

Education & Experience Requirements

• Minimum Education: Bachelor's degree (BA/BS required)
• Experience: 7+ years of professional experience, preferably in the pharmaceutical industry

Key Requirements & Skills: 1) Pharmaceutical Industry Experience

• Prior experience in pharma or biotech environments.
• Understanding of regulatory standards and compliance expectations.

2) GxP Documentation Expertise

• Hands-on experience authoring, reviewing, and managing GxP-compliant documentation.
• Familiarity with cGMP, GLP, GCP and other relevant quality frameworks.
• Pharmacovigilance (PV) experience preferred.

3) SOP Writing Expertise

• 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.

4) Technical Writing Skills

• Excellent writing, documentation, and communication skills.
• Ability to translate complex processes into clear, compliant documentation.
• Experience collaborating with multiple stakeholders and SMEs.

5) Technical & Digital Proficiency

• 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.

6) Soft Skills & Attributes

• 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.

Salary and Other Compensation

The annual [salary/hourly rate] for this position is between $65.00 - 70.00 per hour. Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.

Benefits

The Company offers the following benefits for this position, subject to applicable eligibility requirements:

[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].