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Senior Documentation Area Specialist - FFEx

Employer
Novo Nordisk
Location
Clayton, NC
Start date
May 9, 2024

View more

Discipline
Clinical, Clinical Medicine, Regulatory
Required Education
High School or equivalent
Position Type
Full time
Hotbed
Best Places to Work

Job Details

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 engineering, life sciences, or related industries
  • Minimum of eight (8) years of experience in technical writing, preferably in engineering, life sciences, or related industries required
  • Minimum of five (5) ears of experience with SAP PM and/or MM required
  • Demonstrated strong skills in change management within a regulated environment required
  • Proven expertise in GxP incident investigations and regulatory audit support preferred
  • Ability to read, write & understand complicated product documentation, standard operating procedures, & P&IDs with attention to high-level technical process concepts preferred
  • Expertise in GMP concepts & knowledge of process improvement methodologies such as LEAN and RCFA preferred
  • Proven expertise in planning/organizing and executing resolutions for complex problems solved by cross functional teams preferred
  • Strong communication and organizational skills 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.

    Company

    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. Novo Nordisk employs about 54,400 people in 80 countries and markets its products in around 170 countries. For more information visit novonordisk.com.

    Our US Research & Development hub, located in the Greater Boston area, brings together the best talent to drive life science innovation. Located in Lexington, Watertown and Cambridge, our teams reflect the full scope of R&D, from early research through late-stage clinical development. We are building for the future by creating a distinct R&D community based on collaboration, partnerships, and cutting-edge research across multiple modalities and therapeutic areas. We recognize that improving human health starts here and that patients rely on us. By combining the speed and agility of biotech with the quality, resources, and stability of a large pharmaceutical company, our US R&D hub will benefit from the best of both worlds to develop new medicines that meet the needs of patients.

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    Company info
    Website
    Phone
    617-612-6200
    Location
    75 Hayden Avenue
    Lexington
    MA
    02421
    US

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