Process Writing & Training Support Specialist (M/F/D)

Process Writing & Training Support Specialist (M/F/D)

Key Responsibilities:

SOP & Process Documentation

• Assess gaps between existing sponsor-only processes and future CRO-in-sponsor CTMS processes.
• Identify GxP documents requiring creation or revision.
• Draft new SOPs and update existing SOPs and process documentation.
• Coordinate document review cycles and incorporate stakeholder feedback.
• Finalise documentation in line with applicable quality and compliance requirements.

Training Development & Delivery

• Conduct training needs analyses to identify training requirements by role.
• Update existing training materials and develop new materials, including how-to guides, e-learning content and knowledge assessments.
• Develop training content covering updated processes, SOP requirements, security models and workflows.
• Define training curricula for affected user groups.
• Create FAQs and supporting user documentation.
• Deliver instructor-led training sessions to end users.

Candidate Profile

• Experience in the pharmaceutical, biotechnology or other regulated life sciences industry.
• Strong experience authoring and revising SOPs and GxP documentation.
• Experience developing training materials, work instructions, e-learning or training curricula.
• Understanding of GxP requirements and regulated documentation processes.
• Strong written communication and stakeholder coordination skills.
• Ability to work independently in a remote, project-based environment.
• Experience with clinical operations processes, CTMS implementations or sponsor/CRO operating models is advantageous.

Assignment Details

• Start: ASAP
• Duration: 18 months, potentially 24 months
• Working model: Remote, with onsite onboarding preferred