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Associate Manager, Technical Writing- Ffex

3+ years
Not Disclosed
10 May 1, 2025
Job Description
Job Type: Full Time Education: MBA/BBA/B.Sc/M.Sc Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Associate Manager, Technical Writing - FFEx
Location: Clayton, United States
Job Category: Reg Affairs & Safety Pharmacovigilance


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. 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. This department will set the standards for the aseptic production of the future, using modern technology.

What we offer you:

  • Competitive pay with annual performance bonuses

  • Generous paid time off, including 14 paid holidays

  • Health, Dental, and Vision Insurance from day one

  • Guaranteed 8% 401K contribution plus individual company match option

  • Family-focused benefits, including 14 weeks paid parental leave

  • Free access to Novo Nordisk-marketed pharmaceutical products

  • Tuition assistance, Life & Disability Insurance, and 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?


The Position

You will manage a team of technical writers, guiding the creation of high-quality Standard Operating Procedures (SOPs) for the new facility. Your role involves coordinating with central teams to ensure SOP alignment and consistency, and ensuring that technical documents are clear, accurate, and up-to-date. You will work in close collaboration with the Operational Readiness teams and Quality organization, developing a documentation strategy in accordance with the site start-up plan.


Essential Functions

  • Develop & maintain the SOP landscape & master plan, ensuring adequate SOPs to support operations

  • Manage daily activities of the technical writing team, including staff selection, process confirmation, and setting expectations

  • Train and coach project teams and customers to ensure efficient production of SOPs that comply with standards

  • Coordinate with internal stakeholders and communicate project status, risks, and changes effectively

  • Support implementation of training for competence in SOPs and ensure knowledge content is captured by the training team

  • Champion NNWay & cLEAN® thinking and behaviors within the team

  • Ensure all safety and environmental requirements are adhered to


Physical Requirements

  • Ability to work in an open office environment with possible frequent distractions

  • Ability to travel up to 10% of the time


Development of People

  • Ensure reporting personnel have individual development plans (IDP) aligned with business priorities

  • Manage the communication and application of Novo Nordisk policies and procedures


Qualifications

  • Bachelor's degree in engineering, business, communications, or related field

  • Minimum of 3 years of experience in a manufacturing organization (pharmaceutical manufacturing preferred)

  • At least 3 years of supervisory experience required

  • Strong project management skills, especially in SOP development

  • Pharmaceutical manufacturing quality system knowledge (FDA requirements preferred)

  • Ability to develop and implement documentation strategies and standards

  • Experience in coordinating documentation projects and ensuring timely delivery

  • Ability to collaborate with cross-functional teams, including product managers, engineers, and vendors


Novo Nordisk is an equal opportunity employer, committed to diversity and inclusion in the workplace.