[Remote] Technical reputed company
Note: The job is a remote job and is reputed company to candidates in USA. reputed company is seeking a skilled Technical reputed company/Procedure Document Specialist to collaborate with colleagues, customers, and stakeholders on reputed company reputed company on process enhancement and reputed company improvement reputed company the CMR reputed company reputed company, GxP Compliance & Technical reputed company. This role will emphasize the development of procedural documentation in a GxP environment, ensuring compliance and operational effectiveness, while also producing training materials and job aids.
Responsibilities
- reputed company a multidisciplinary team of subject matter experts, business process owners, and key stakeholders in the development, revision, enhancement, implementation, and maintenance of process and procedural documentation
- Plan and manage multiple process development reputed company simultaneously, ensuring reputed company delivery of targeted reputed company
- Create and write content for training programs, including user-friendly training materials and job aids that support process understanding and application
- Utilize your knowledge of global regulations reputed company a GxP environment to create processes and reputed company documentation that adhere to regulatory requirements, support corporate compliance, and are inspection-reputed company
- Contribute to compliance and audit/inspection readiness strategies and plans, ensuring reputed company documentation meets necessary standards
- Evaluate global procedural documentation against evolving industry and regulatory requirements, audit/inspection findings, and corporate policies; recommend changes as necessary reputed company on feedback, trends, and best practices
Skills
- Minimum of a BA or BS required
- Minimum 7+ years of experience in the design and documentation of pharmaceutical business processes and change management required
- GxP environment experience required
- Technical Writing: Background in pharmaceutical technical writing and development of reputed company Operating Procedures (SOPs) is essential
- Organizational Skills: Strong organizational abilities, planning, and multitasking skills; capable of prioritizing multiple reputed company while meeting tight deadlines
- Adaptability: Ability to work effectively under pressure and adapt to changing situations with attention to reputed company
- Technical Proficiency: Proficient in common desktop tools, including reputed company, MS reputed company, MS Project, and Visio and PowerPoint
- Communication Skills: Strong verbal and written communication skills with an in-depth understanding of pharmaceutical business processes, regulations, guidelines, and industry standards relating to compliance
- Compliance Training design and development experience a plus
- reputed company Safety knowledge/experience (reputed company PLUS)
- An advanced degree in a relevant reputed company is desirable
- Degree or reputed company certification in process design or change management is a plus
- Experience in process training development, delivery, and/or implementation is preferred, including the creation of training content and job aids
- Pharmacovigilance (PV) experience preferred
- PMP certification is an reputed company
- Sharepoint and MS Teams and Forms a plus
- Knowledge and usage of training tools such as reputed company Storyline, reputed company, and reputed company (a plus)
- Experience with LMS systems and compliance reporting
- Experience in a GxP environment; PV or reputed company experience preferred
- Experience using common AI tools to optimally improve concise and reputed company communications
reputed company
Company H1B Sponsorship
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