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Documentation Specialist
2 months ago
We are seeking a skilled Documentation Specialist to support the operational aspects of procedural documentation management. This role involves managing and facilitating the creation, revision, and organization of regulatory affairs and pharmacovigilance procedural documentation.
Key Responsibilities:
- Manage the development and revision of procedural documentation such as SOPs, job aids, forms, and process guides.
- Lead and complete documentation impact assessments and ensure timely release and implementation of documents.
- Support process owners in developing process maps and facilitating documents through draft, review, and approval cycles.
- Conduct periodic assessments of procedural content for adherence to format, content, and style guidelines.
- Manage the overall documentation change control process and ensure efficient access, review, and approval.
- Organize and maintain current procedural documents for easy access by GRACS end users.
- Support internal audits and inspections related to process documentation.
Requirements:
- Bachelor's degree or higher required.
- 6+ years of industry experience in regulatory affairs or pharmacovigilance.
- Experience in managing procedural documentation and integrated project plans.
- Familiarity with Veeva Vault Quality Docs preferred.
- Strong skills in collaborating with cross-functional teams and stakeholders.
About ManpowerGroup, Parent Company of: Manpower, Experis, Talent Solutions, and Jefferson Wells
ManpowerGroup is committed to providing equal employment opportunities in a professional, high quality work environment. It is the policy of ManpowerGroup and all of its subsidiaries to recruit, train, promote, transfer, pay and take all employment actions without regard to an employee's race, color, national origin, ancestry, sex, sexual orientation, gender identity, genetic information, religion, age, disability, protected veteran status, or any other basis protected by applicable law.