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Documentation Area Specialist II/III

Initial Therapeutics, Inc.

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 approximately 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 Execute system administration related to document control, creation and revision for various Novo Nordisk documentation. Supports processing SOPs, System Specifications, & ownership of those documents. Relationships Reports to Manager. Essential Functions Provide specialist knowledge on the writing process to ease understanding, choice of document type, structure, style & language usage of the operational documents Review local documents to ensure clear & reader friendly language Collaborate cross‑functionally within site Provide process administrative support for data processes Coach document owners in the knowledge of good communication & standards in operational documents Support standardization projects as needed Develop & maintain internal & external stakeholder relationships Support project completion with metrics & timelines realized Proactively engage in entry‑level complexity systematic problem‑solving activities collaborating on solutions regarding document processes & quality compliance Proficient in Change Control process to support revision of standards May support & act as a backup for the Site Expert/Superuser for Quality DOCS as required Process documents via applicable NN document management tools Follow all safety and environmental requirements in the performance of duties Other duties 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 Associate’s degree in business or a technical field of study from an accredited university required with a minimum of three (3) years of experience in technical writing or document processing, preferably in engineering, life sciences, or related industries required In lieu of Associate degree and three (3) years of experience, may consider a High School Diploma or equivalent required with a minimum of five (5) years of experience in technical writing or document processing, preferably in engineering, life science or related industries required Knowledgeable in GMP concepts and SAP Plant Maintenance preferred Knowledge of process improvement methodologies such as LEAN preferred Strong communication and organizational skills preferred Highly proficient in the following software applications/tools: MS Word 2010, Adobe Acrobat Pro (latest version), Excel, PowerPoint, & Visio required Proven expertise in planning, organizing, managing, executing, & revising the work plan & schedules for complex problems solved by cross functional teams required Demonstrated strong skills in change management within NN preferred We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. 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. #J-18808-Ljbffr Initial Therapeutics, Inc.

Vacancy posted 4 days ago
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