Senior Documentation Area Specialist - FFEx

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 12 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 Novo Nordisk documentation. Serves as team lead of documentation control management team, serving as technical writing expert, incident investigator, and SAP Plant Maintenance master data administrator. Leads, coaches & mentors other technical writers working to revise documents.

 

Relationships

Manager.

 

Essential Functions

• Design & own process for implementation of new & revised documents, to include change control, document creation, assessment of training/documentation & routing/approval process
• Serve as editor in documentation control process with focus on compliance that guarantees ease of use for document owners, users & quality approvers
• Provide system administration leadership for SAP Plant Maintenance data processes
• Collaborate cross-functionally & maintain productive stakeholder relationships
• Support authors in the writing process with language usage, document control process & related software
• Serve as SOP Subject Matter Expert
• Provide specialist leadership on the writing process to ease understanding, choice of document type, structure & language usage of the operational documents
• Gain technical understanding of applicable plant operation processes and apply technical knowledge during the creation and revision of documentation
• Serves as Utilities organization lead deviation investigator as part of the site incident investigation process
• Serve as mentor for junior specialists, training them in the knowledge of incident investigations & standards in operational documents
• Lead documentation standardization projects as needed
• Process documents via applicable Novo Nordisk document management tools
• Develop documentation performance indicators and drive improvement through them
• Accountable for documentation related deliverables completed with metrics & timelines realized
• Follow all safety and environmental requirements in the performance of duties
• 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 in business or a technical field of study from an accredited university required
  • May consider an Associate’s degree in business or a technical discipline from an accredited university with ten (10) years of experience in technical writing required, preferably in engineering, life sciences, or related industries
  • May consider a High School Diploma or equivalent with twelve (12) years of experience in technical writing required, preferably in e