Description:
TOP SKILLS PER MGR:
- Pharma Industry Experience
- Experience w/GxP documentation required (not GMP)
- SOP Writing expertise
- Patient Safety knowledge/experience (HUGE PLUS)
Job Summary
We are seeking a skilled Technical Writer/Procedure Document Specialist to collaborate with colleagues, customers, and stakeholders on projects focused on process enhancement and continuous improvement within the CMR Strategic Operations, GxP Compliance & Technical Operations.
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.
Key Responsibilities:
- Lead 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 projects simultaneously, ensuring timely delivery of targeted outcomes.
- 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 within a GxP environment to create processes and related documentation that adhere to regulatory requirements, support corporate compliance, and are inspection-ready.
- Contribute to compliance and audit/inspection readiness strategies and plans, ensuring all documentation meets necessary standards.
- Evaluate global procedural documentation against evolving industry and regulatory requirements, audit/inspection findings, and corporate policies; recommend changes as necessary based on feedback, trends, and best practices.
Qualifications:
- Education: Minimum of a BA or BS required; an advanced degree in a relevant field is desirable.
Degree or professional certification in process design or change management is a plus.
- Experience:
- Minimum 7+ years of experience in the design and documentation of pharmaceutical business processes and change management required.
- Experience in process training development, delivery, and/or implementation is preferred, including the creation of training content and job aids.
- GxP environment experience required; pharmacovigilance (PV) experience preferred.
- Project Management Skills: Proven ability to manage multiple projects simultaneously; PMP certification is an advantage.
- Technical Writing: Background in pharmaceutical technical writing and development of Standard Operating Procedures (SOPs) is essential.
- Organizational Skills: Strong organizational abilities, planning, and multitasking skills; capable of prioritizing multiple projects while meeting tight deadlines.
- Adaptability: Ability to work effectively under pressure and adapt to changing situations with attention to detail.
- Technical Proficiency: Proficient in common desktop tools, including MS Word, MS Excel, MS Project, and Visio and PowerPoint. Sharepoint and MS Teams and Forms a plus.
- 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.
Critical Skills/Experience
1) Experience in a GxP environment; PV experience preferred
2) Strong project management skills with a proven ability to manage multiple projects simultaneously; PMP certification a plus
3) Background in pharmaceutical technical writing, specifically Standard Operating Procedures (SOPs)
4) Ability to create training materials and job aids that facilitate process understanding and implementation
5) Proficiency in using Visio for process mapping and diagram creation
6) Ability to work on critical initiatives under pressure while maintaining a keen attention to detail
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