Senior Technical Writer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

The Technical Writer is responsible for driving results in a fast-paced multi-faceted environment by leading the technical writing of GMP documents and investigations associated within the NJ Stability Lab Operations.

Assignments are of varying complexity, where sound judgment and self-drive/initiative are required to resolve problems and make recommendations/decisions.

This position requires technical writing and investigations to be completed in compliance with all applicable procedures, standards and GMP regulations as well as all local, state, federal and international regulations and guidelines (FDA, EPA, DEA, OSHA, etc.)

• Plan, execute, and write laboratory investigations, in coordination with laboratory supervisors and QC Technical Leads, identifying immediate/root causes and determining effective corrective and preventative actions

• Write and edit detailed SOPs, validation protocols/reports, forms, analytical and technical documents and reports from conception to utilization

• Proofread documents for content and identify non-standard format or wording, and errors within documents

• Review data where required pertaining to documents being drafted

• Participate in gap assessments of technical documentation to ensure methods are up to current standards, and that processes investigated are present and functioning optimally. Provide recommendations/solutions to remediate any recognized gaps

• Present authorship strategy to management to get pre-approval and endorsement

• Build and maintain a progress-tracking matrix on document generation, qualification execution, document review and approval (Escalate any issue/delay to management as applicable)

• Collect and trend historical data

• Responsible for preparing technical documentation for highly complex issues (i.e. high impact investigations)

• Make contributions to improved processes and templates as it relates to laboratory investigations

• Provide training and mentorship for new investigation writers and lab analysts as it pertains to technical writing

• Maintain individual training completion in a compliant state

• Complete investigation records and CAPAs in a timely and compliant fashion

• Provides information and support to escalations associated with laboratory investigations

• Support as SME for Health Authority Inspections

• Provide input to functional laboratory meetings

• Make contributions to, and occasionally lead, continuous improvement teams

• Provide leadership and insight as a member of global project teams

Additional Description for Pay Transparency: