Associate Manager, Technical Writing - FFEx
Location: Clayton, United States
Job Category: Reg Affairs & Safety Pharmacovigilance
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. 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. This department will set the standards for the aseptic production of the future, using modern technology.
What we offer you:
Competitive pay with annual performance bonuses
Generous paid time off, including 14 paid holidays
Health, Dental, and Vision Insurance from day one
Guaranteed 8% 401K contribution plus individual company match option
Family-focused benefits, including 14 weeks paid parental leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition assistance, Life & Disability Insurance, and 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?
The Position
You will manage a team of technical writers, guiding the creation of high-quality Standard Operating Procedures (SOPs) for the new facility. Your role involves coordinating with central teams to ensure SOP alignment and consistency, and ensuring that technical documents are clear, accurate, and up-to-date. You will work in close collaboration with the Operational Readiness teams and Quality organization, developing a documentation strategy in accordance with the site start-up plan.
Essential Functions
Develop & maintain the SOP landscape & master plan, ensuring adequate SOPs to support operations
Manage daily activities of the technical writing team, including staff selection, process confirmation, and setting expectations
Train and coach project teams and customers to ensure efficient production of SOPs that comply with standards
Coordinate with internal stakeholders and communicate project status, risks, and changes effectively
Support implementation of training for competence in SOPs and ensure knowledge content is captured by the training team
Champion NNWay & cLEAN® thinking and behaviors within the team
Ensure all safety and environmental requirements are adhered to
Physical Requirements
Ability to work in an open office environment with possible frequent distractions
Ability to travel up to 10% of the time
Development of People
Ensure reporting personnel have individual development plans (IDP) aligned with business priorities
Manage the communication and application of Novo Nordisk policies and procedures
Qualifications
Bachelor's degree in engineering, business, communications, or related field
Minimum of 3 years of experience in a manufacturing organization (pharmaceutical manufacturing preferred)
At least 3 years of supervisory experience required
Strong project management skills, especially in SOP development
Pharmaceutical manufacturing quality system knowledge (FDA requirements preferred)
Ability to develop and implement documentation strategies and standards
Experience in coordinating documentation projects and ensuring timely delivery
Ability to collaborate with cross-functional teams, including product managers, engineers, and vendors
Novo Nordisk is an equal opportunity employer, committed to diversity and inclusion in the workplace.
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