Pharmaceutical Technical Writer

About the Department

At Novo Nordisk, we want to make a difference. For more than 100 years, we have led the way in diabetes care. Being part of Novo Nordisk allows our employees to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world.

In NC, we operate three pharmaceutical manufacturing facilities that are responsible for fulfilling different steps in our injectable and oral treatment supply chains.  Our legacy Injectable Finished Products (IFP) facility in Clayton, NC is a 457,000 square foot aseptic "fill and finish" site that is responsible for producing innovative, injectable diabetes and obesity treatments. At IFP, you’ll join a global network of manufacturing professionals who are passionate about what they do.

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

Execute the document creation & revision process for IFP standards & other documents in support of processes, the Learning & Development team, & Quality partners. Serve as the Subject Matter Expert (SME) in local change control process to support revision of standards. Interface with technical writers on other sites & in Manufacturing Development.

Relationships

Manager.

Essential Functions

• Support document owners in the writing process with language usage, document revision process, change control process & related tools
• Write & manage deviations as well as all  documentation management, to include active DCC
• Review local QMS documents to ensure clear & reader friendly language
• Translate production floor tasks into job instructions (JIs)
• Resolve all iDoc issues
• Collaborate cross-functionally with cLEAN®, Learning & Development & Quality partners
• Provide specialist knowledge on the writing process to ease understanding, choice of document type, structure, style, & language usage of the operational documents
• Coach document owners in good communication & standards in operational documents
• Support IFP standardization projects as needed
• Support the document processing of revisions to IFP Framework level documents in collaboration with IFP process groups
• Develop & maintain internal & external stakeholder relationships
• Ensure projects are completed with metrics & timelines realized
• Engage proactively in systematic problem-solving activities & collaborate on solutions regarding document processes & quality compliance
• Follow all safety & 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

• Associate’s degree in Administrative or a technical field of study from an accredited university required
• May consider a High School Diploma or equivalent with a minimum of two (2) years of experience in technical writing, preferably in engineering, life sciences, software, or related industries
• Minimum of three (3) years of experience in technical writing, preferably in engineering, life sciences, software, or related industries preferred
• Ability to read, write & understand complicated product documentation & standard operating procedures with attention to high-level concepts preferred
• Knowledgeable in core work processes & GMP concepts, knowledge of process improvement methodologies such as LEAN preferred
• Expert in change control [CR], MS WORD 2010 & highly proficient in the following software applications/tools: Adobe Acrobat Pro (latest version), EXCEL, PowerPoint, Visio & HTML preferred
• Ability to manage multiple CRs & deadlines preferred
• Proven expertise in planning/organizing, managing, executing, & revising the work plan, & schedules for complex problems solved by cross functional teams preferred
• Demonstrated strong skills in change management 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.