Documentation Area Specialist Ii - Ffex

2+ years

Not Disclosed

Remote, USA

10 Nov. 11, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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

Job Title: Document Control Specialist – Fill & Finish Expansions (FFEx)

Location: [Insert Location]
Department: Fill & Finish Expansions (FFEx)

About Novo Nordisk

At Novo Nordisk, we are at the forefront of the global healthcare industry, with a rich history spanning over 100 years and a commitment to improving the lives of millions of patients. We are a leading healthcare company that employs over 53,000 people in 80 countries, treating over 32 million people with chronic diseases every day. Our mission is to not only be the best company in the world but to be the best company for the world.

Join us in shaping the future of aseptic production and help us serve the growing needs of patients globally. As part of the Fill & Finish Expansions (FFEx) team, you will be responsible for supporting the design, planning, and building of innovative aseptic filling capacity across our global production network. You’ll be helping us rethink and set the standards for the aseptic production of tomorrow.

What We Offer

Competitive Pay and Annual Performance Bonus for all positions
Generous Paid Time Off including 14 Paid Holidays
Health, Dental, and Vision Insurance effective day one
8% 401K contribution plus individual company match option
12 weeks Paid Parental Leave and 6 weeks Paid Family Medical Leave
Free access to Novo Nordisk-marketed pharmaceutical products
Tuition Assistance and Employee Referral Awards
Life & Disability Insurance

At Novo Nordisk, you’ll find a culture of innovation, resources for growth, and mentorship to help you build a rewarding career. Are you ready to make a difference? Join us and help us make what matters.

The Position

As a Document Control Specialist within the FFEx department, you will play a key role in ensuring efficient and compliant document management for aseptic production activities. You will support the creation, revision, and control of various operational documents and provide administrative support for processes that ensure document quality and compliance. This includes collaborating across multiple departments to manage documents related to SOPs, system specifications, and other essential materials.

Key Responsibilities

Document Management
- Provide expert guidance on document writing processes, structure, style, and language usage to ensure clarity and consistency in operational documents.
- Review local documents to ensure they are clear, concise, and reader-friendly.
- Collaborate cross-functionally to manage the creation, revision, and archiving of documents using Novo Nordisk's document management tools.
Process Support & Standardization
- Support process improvements for document management systems, ensuring compliance with internal and external quality standards.
- Actively contribute to standardization projects and assist document owners with adhering to communication and documentation standards.
Cross-Functional Collaboration
- Work with multiple teams, including Quality, Production, and IT, to ensure smooth and efficient document processes.
- Proactively engage in problem-solving activities and provide administrative support for data and document-related processes.
- Ensure effective change management and compliance with the Change Control process in document revisions.
Metrics & Project Support
- Assist with project completion by tracking document timelines, milestones, and ensuring all tasks are aligned with project goals and deadlines.
- Support the site’s continuous improvement activities by helping to resolve systematic problems regarding document processes and quality compliance.

Qualifications

Education:
- Associate’s degree in Business, Technical Writing, or a related field. Alternatively, a High School diploma with 5+ years of experience in technical writing or document management may be considered.
Experience:
- Minimum of 3 years of experience in technical writing or document processing, preferably within engineering, life sciences, or related industries.
- Experience with GMP concepts and knowledge of SAP Plant Maintenance is preferred.
- Familiarity with process improvement methodologies such as LEAN is a plus.
Skills:
- Proficient in Microsoft Office Suite, including MS Word, Excel, PowerPoint, and Visio.
- Strong communication and organizational skills.
- Ability to manage and prioritize tasks in a fast-paced environment.
Additional Competencies:
- Expertise in planning, organizing, and managing complex projects and schedules across cross-functional teams.
- Proven ability to handle change management processes and document revisions within a global organization.

Physical and Travel Requirements

Physical Requirements: Ability to work in an open office environment with frequent distractions.
Travel: 0-10% overnight travel required (subject to role-specific needs).

Why Join Novo Nordisk?

At Novo Nordisk, we believe in transforming lives, both for our patients and our employees. You’ll be part of a global, diverse community that encourages innovation, collaboration, and personal growth. We’re committed to providing a work environment where you can make a real impact and help shape the future of healthcare.

Equal Opportunity Employer

Novo Nordisk is an equal opportunity employer. We value diversity and are committed to creating an inclusive culture that celebrates the uniqueness of our employees and the patients we serve. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status.

How to Apply

If you're ready to be a part of Novo Nordisk's dynamic team, please submit your application through our online portal. We look forward to hearing from you!

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Documentation Area Specialist Ii - Ffex

Job Description

Job Title: Document Control Specialist – Fill & Finish Expansions (FFEx)

About Novo Nordisk

What We Offer

The Position

Key Responsibilities

Qualifications

Physical and Travel Requirements

Why Join Novo Nordisk?

Equal Opportunity Employer

How to Apply

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