What are the responsibilities and job description for the Documentation Area Specialist II/III position at BioSpace?
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
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 engaged 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 requiredIn 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.
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.
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
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 engaged 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 requiredIn 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.
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.