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
Manage team of technical writers. Responsible for planning & execution the creation of high quality Standard Operational Procedures (SOPs) for the new facility. Coordinate with central teams on alignment of SOPs & use of standards. Ensure that technical documents are clear, accurate & updated. Work in collaboration with Operational readiness teams and Quality organization. Develop documentation strategy and standards according to the site start-up plan.
Relationships
Reports to Senior Manager.
Essential Functions
- Develop & maintain the SOP landscape & master plan to ensure establishment of adequate SOPs to support operations
- Manage daily activities of the technical writing team, including but not limited to staff selection, process confirmation, setting expectations & employee development
- Ensure Site technical writing processes for Standard Operating Procedures (SOPs) are followed to standard by training SOP authors & coordinating with internal key stakeholders
- Provide training & coaching to ensure project team & customers possess the required skills to work efficiently & produce SOPs that comply with the standard
- Ensure work package status, changes & on-going risks are clearly communicated & escalated with all relevant stakeholders, senior Leadership Team (SLT) & project management teams
- Support implementation of Training for Competence in SOP's by ensuring training & knowledge content is shared & captured with the training team
- Ensure projects are completed with metrics and timelines realized
- Act as a champion & role model for the NNWay & for cLEAN® thinking & behaviors
- Follow all safety & environmental requirements in 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.)
Development Of People
Supervisory. Ensure that reporting personnel have individual development plans (IDP), with annual goals and measurements that are consistent with the priorities of the business, and that interim reviews are held so that their work is focused on those priorities, and they understand their level of accountability for results and the measurement process. Ensure that the IDP forms include completed learning and aspiration plans and are in place for all reporting personnel to enable the achievement of goals and capability to assume increased levels of responsibility. Manage the application and communication of all Novo Nordisk policies, procedures, and Novo Nordisk Way.
Qualifications
- Bachelor's Degree in engineering, business, communications or related field from an accredited university required
- Minimum of three (3) years of experience in a manufacturing organization required; pharmaceutical manufacturing preferred
- Minimum of three (3) years of direct supervisory experience required
- Strong project management skills to drive development of high-quality SOPs according to project plan milestones & deliverables preferred
- Pharmaceutical manufacturing quality system knowledge, including knowledge of FDA requirements preferred
- Ability to develop and implement documentation strategy and standards to ensure consistency and quality preferred
- Develop process for content creation (write, edit and review) such as user manuals required
- Solid business understanding of manufacturing operations to assess current & future needs preferred
- Coordinate documentation projects, set deadlines and ensure timely delivery of high-quality content required
- Strong collaborating skills working closer with product manager, engineers, vendors and designers preferred
- Communicate with stakeholders to understand needs and prioritize tasks preferred
- Organizational change management preferred
- Evaluate and implement tools and process to enhance the efficiency of the team required
- Ability to set directions & deliver results preferred
- Proven expertise in mentoring/development, planning/organizing, managing execution & revising the work plan for complex problems solved by cross functional teams preferred
- 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 recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing.
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.
Top Skills
What We Do
Novo Nordisk is a leading global healthcare company, founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat diabetes and other serious chronic diseases such as obesity and rare blood and endocrine disorders. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease.
We are powered by technology. Our Global Research Technologies, Medical Devices as a software, and Data Science teams are on the cutting edge of developing and supporting our life-saving medications.
Why Work With Us
Our purpose is to drive change to defeat serious chronic diseases, built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines and working to prevent and ultimately cure the diseases we treat.
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Hybrid Workspace
Employees engage in a combination of remote and on-site work.