Validation Lead with Technical writer exp

Validation Lead with Technical writer exp

Location : Indianapolis, IN on site 3 Days a week

Roles and responsibilities

Overall Purpose: Ensure that all Configuration Items (CIs) within the Clinical Design and
Operations organization are in full compliance with clients validation standards by overseeing documentation activities, coordinating with stakeholders, assigning work, and monitoring validation progress across systems.

Key Responsibilities:
Compliance Oversight & Monitoring
Ensure all Clinical Design and Operations systems (CIs) adhere to clients validation
guidelines.
Monitor validation activities across CIs to confirm compliance and documentation
integrity.
Oversee systems managed within Tower X, ensuring ongoing adherence to validation
standards.
Stakeholder Engagement & Facilitation
Proactively initiate and lead meetings with System Owners, System Custodians, CSQA,
BQA, SMEs, and other stakeholders.
Facilitate risk evaluation meetings and drive the determination of appropriate Risk
Categories for each CI.
Ensure that Risk Categories are registered and documented accurately in CSA
Launchpad and CMDB.
Build rapport with team members, System Owners, System Custodians, CSQA, BQA,
SMEs, and other stakeholders to foster strong working relationships and ensure smooth
collaboration across validation activities.
Documentation Management & Guidance
Identify what validation documents are needed or require updates.
Collaborate with Technical Writers to ensure validation documentation is complete,
accurate, and audit ready.
Provide guidance and standards to Technical Writers to ensure document consistency
and regulatory alignment.
Demonstrate proactive ownership and independent decision-making by identifying
documentation gaps, initiating actions, and guiding validation activities without relying on
constant direction while still collaborating with the team when coordination is required.
Encourage Technical Writers to develop increasing independence in identifying
documentation needs and managing tasks as they become more familiar with the
validation process and system landscape, while continuing to collaborate closely with
stakeholders and the validation team.
Assignment & Workload Distribution
Logically assign CIs to Technical Writers to balance workloads and minimize
bottlenecks.
Develop a reporting and tracking structure (e.g., via Jira or similar tools) to:
Show current status of validation documentation across all CIs.
Clearly detail assigned tasks using a standardized structure (e.g., Epic, Story,
Task), outlining scope, responsible writer, due dates, and context.
Enable management to easily understand progress and gaps.