Job Details
Life Science Consultant - Content Writer
5146
Posted: 20/11/2024
- $Competitive
- -, United States
- Contract
Role Title: Life Sciences Consultant, Content Writer
The Consultant will be assisting a large life sciences client in enhancing its processes and workflows to support an increasingly global product footprint. Work closely with internal, client and vendor team members to understand opportunities for improvement both globally and regionally based on business and regulatory need. Enhance or develop content packages and manage them through the corporate approval process. Effort includes analyzing and aligning change impact across multiple documents and functional areas. Team driven approach to stakeholders requires consensus building and priority management.
What you will be doing:
Manage and lead projects for the development of procedural documents for global development by:
The Consultant will be assisting a large life sciences client in enhancing its processes and workflows to support an increasingly global product footprint. Work closely with internal, client and vendor team members to understand opportunities for improvement both globally and regionally based on business and regulatory need. Enhance or develop content packages and manage them through the corporate approval process. Effort includes analyzing and aligning change impact across multiple documents and functional areas. Team driven approach to stakeholders requires consensus building and priority management.
What you will be doing:
Manage and lead projects for the development of procedural documents for global development by:
- Assessing how the creation or update of procedural documents impacts other procedural documents.
- Identifying the stakeholders/SMEs and ensures they are engaged in the content development/revision activities, including review and approval cycles.
- Translate complex cross-functional concepts to process maps.
- Address deviations, inspection commitments, corrective/ preventative actions, and other gaps.
- Facilitate process mapping activities capturing process details (scope, boundaries, inputs, outputs, process steps and sequence and process visualization.
- Collaborate with Quality Managers during content development to ensure alignment with Content Standards and Lean Writing Principles.
- Manage document review and approval workflows.
- Maintain project schedule, identifying and mitigating risks or issues escalate with recommendations as needed.
- Coordinate approval with business units and Quality on approval.
- Minimum 5-10 years in an external client facing role as a consultant or other relevant experience.
- Industry and/or consulting experience in Global Pharma or Biotech.
- Ability to understand and discuss complex information with people of diverse occupational backgrounds.
- Experience in controlled procedural document principles, process design and leading process improvements.
- Design/development of SOPs, supporting documents and forms/templates.
- Ability to understand and translate complex processes into lean processes.
- Ability to write in explanatory and procedural styles for multiple audiences.
- Awareness of GxP regulatory requirements.
- Strong leadership, organizational and project management skills.
Lauren McQuade
Vice President | Contract
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