Senior Technical Writer - QC Documentation & Standards Lead

Novo Nordisk; Clayton (NC); On-site; USD 95,000 - 125,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401K with company match

Paid holidays

Tuition Assistance

Life & Disability Insurance

Employee referrals

Job summary

Novo Nordisk's Fill & Finish Expansions (FFEx) seeks a senior Technical Writer to design, improve, and own the QC document creation and revision process at Clayton site. You will serve as the English language technical writing expert for QC documents and mentor other writers and SMEs.

You will collaborate across departments, drive document governance, ensure regulatory compliance, and support change management initiatives while delivering clear, reader-friendly SOPs and API/IFP/OFP framework

Qualifications

• Bachelor's Degree or equivalent combination of education & experience.
• Minimum five years of experience in technical writing, preferably in engineering, life sciences, software, or related fields.
• Ability to read, write & understand complicated product documentation & SOPs with attention to high-level concepts.
• Knowledge of GMP concepts; Lean/continuous improvement preferred.

Responsibilities

• Design & own the process for implementation of QC documents, including change control, creation, and routing/approval.
• Improve local change processes for revision of QC documents to ensure ease of use for owners, users, and approvers.
• Collaborate cross-functionally with other departments and maintain stakeholder relationships.
• Support authors in writing with language usage and document control processes.
• Review local QC documents to ensure clear, reader-friendly language.
• Participate in SOP Expert Network, Process Workshops, and document governance groups.
• Provide specialist knowledge on document writing to aid understanding, structure, and language usage.

Skills

Technical writing

Change management

Communication

Process improvement

Documentation control

Cross-functional collaboration

Education

Bachelor's degree

Job description

Novo Nordisk's Fill & Finish Expansions (FFEx) seeks a senior Technical Writer to design, improve, and own the QC document creation and revision process at Clayton site. You will serve as the English language technical writing expert for QC documents and mentor other writers and SMEs.

You will collaborate across departments, drive document governance, ensure regulatory compliance, and support change management initiatives while delivering clear, reader-friendly SOPs and API/IFP/OFP framework