Senior Technical Writer - Quality Control Support

Initial Therapeutics, Inc.; Clayton (NC); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

14 paid holidays

Health insurance

Dental insurance

Vision insurance (effective day one)

401(k) with company match

Parental & family leave

Life & disability insurance

Employee referral awards

Tuition assistance

Free Novo Nordisk products

Job summary

Novo Nordisk in Clayton, NC seeks an experienced QC Documentation Specialist to design, improve, and maintain QC documents. You will serve as the English language technical writing expert for QC materials and lead/coaching others in writing standards.

The role requires a Bachelor's degree and 5+ years in technical writing within life sciences or related fields. Strong collaboration across departments is essential with a focus on compliant, reader-friendly documentation.

Qualifications

• Bachelor's Degree or equivalent combination of education & experience.
• Minimum five (5) 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 high-level concepts.
• Knowledgeable in core work processes & GMP concepts; knowledge of LEAN preferred.
• Proven planning/organizing, managing, executing skills; change management experience preferred.

Responsibilities

• Design & own process for implementation of new API, IFP, & OFP QC documents, including change control, document creation, training documentation, and routing/approval.
• Improve local change process for revision of QC documents with emphasis on compliance and ease of use.
• Collaborates cross-functionally with other departments and maintains stakeholder relationships.
• Supports authors in the writing process with language usage, document control processes & tools.
• Reviews local QC documents to ensure clear & reader-friendly language.
• Participates in SOP Expert Network, Process Workshops, and other document governance groups.
• Provides specialist knowledge on writing processes to aid document type selection and language usage.

Skills

Technical writing

GMP knowledge

Change management

Documentation control

Cross-functional collaboration

Education

Bachelor's degree

Job description

About the Department

You will be joining Fill & Finish Expansions (FFEx), which is responsible for all major expansion activities within aseptic production, solid dosage forms, finished products, fill & finish warehousing, and QC across all production areas in Product Supply. The area is anchored in Product Supply, Quality & IT, which globally employ approx. 20,000 of Novo Nordisk’s 50,000 employees.

FFEx is a newly established and growing area with the responsibility to design, plan, and build all new aseptic filling capacity across Novo Nordisk to serve the needs of millions of patients. We do it by rethinking our production facilities with the use of modern technology, as we are setting the standards for the aseptic production of the future. Facilities designed today which we will still be proud of 20 years from now. FF Expansions has a global approach, where you will be working with multiple sites and cultures across the world.

What we offer you:

• Leading pay and annual performance bonus for all positions
• All employees enjoy generous paid time off including 14 paid holidays
• Health Insurance, Dental Insurance, Vision Insurance – effective day one
• Guaranteed 8% 401K contribution plus individual company match option
• Family Focused Benefits including 14 weeks paid parental & 6 weeks paid family medical leave
• Free access to Novo Nordisk-marketed pharmaceutical products
• Tuition Assistance
• Life & Disability Insurance
• Employee Referral Awards

At Novo Nordisk, you will find opportunities, resources, and mentorship to help grow and build your career. Are you ready to realize your potential? Join Team Novo Nordisk and help us make what matters.

The Position

Designs, improves & maintains the document creation & revision process for QC documents at site Clayton in order to support Process Responsible personnel on-site. Serves as English language technical writing expert for QC documents. Leads, trains, coaches & mentors other QC technical writers & SME's working to establish documents.

Relationships

Reports to Manager, QC Support.

Essential Functions

• Design & own process for implementation of new API, IFP, & OFP (Local & Framework) QC documents, to include change control, document creation, assessment of training/documentation & routing/approval process
• Improve local change process for revision of QC documents, with focus on compliance with existing procedures in a way that guarantees ease of use for document owners, users & quality approvers
• Collaborates cross-functionally with other departments & maintains stakeholder relationships
• Supports authors in the writing process with language usage, document control process & related tools
• Reviews local QC documents to ensure clear & reader friendly language
• Participates in SOP Expert Network, Process Workshops, & other document governance groups
• Provides specialist knowledge on the writing process to ease understanding, choice of document type, structure & language usage of the operational documents
• Coaches’ others in the knowledge of good communication & standards in operational documents
• Supports &/or leads QC standardization projects as needed
• Supports the document processing of revisions to API, IFP, & OFP Framework level documents in collaboration with QC process work packages
• Ensure projects are completed with metrics & timelines realized
• Other accountabilities, as assigned.

Physical Requirements

Ability to work in an open office environment with the possibility of frequent distraction. Ability to travel up to 10% of the time (% can change on a case-by-case basis based on the role).

Qualifications

• Bachelor's Degree or equivalent combination of education & experience required
• Minimum five (5) years of experience in technical writing, preferably in engineering, life sciences, software, or related fields required
• Ability to read, write & understand complicated product documentation & standard operating procedures with attention to high-level concepts required
• Knowledgeable in core work processes & GMP concepts; knowledge of process improvement methodologies such as LEAN preferred
• Proven expertise in planning/organizing, managing, executing preferred
• Revising the work plan preferred
• Schedules for complex problems solved by cross functional teams preferred
• Demonstrated strong skills in change management within NN preferred
• Communication Skills: Must be ability to communicate effectively with various stakeholders in Novo Nordisk preferred

We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.

At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and defeating diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.

Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations.

If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.