Job Description

Job Description

Medical Affairs Content Quality Specialist

Location: 3 days onsite/week in Indianapolis, IN

12-month contract, with high likelihoods of extension

Start: Dec 8, 2025 or Jan 5, 2026

Interview Process: Starting next week, max 2 rounds

Objective:

Our Client's Medical Affairs Content Quality Process team leads the medical content review and approval process , ensuring all medical content meets the highest standards of scientific accuracy, quality, and compliance so customers receive timely, reliable information. The team is tasked with the oversight and execution of the Medical Content Review Processes which includes:

• Defining the end-to-end medical content review process, from submission through approval.
• Driving organizational change management (OCM), including design and delivery of training, provide clear communications to support adoption.
• Measure key performance metrics, such as monitoring quality and cycle time, identifying best practices, and removing barriers to efficiency.

Their commitment to excellence ensures a process that is transparent, auditable, and continuously improving , supporting both business agility and regulatory expectations.

This role will primarily focus on monitoring quality and risk assessments of the Global and US Medical Content Approval (MCA) Process. The primary responsibilities may include those listed below as deemed appropriate by line management, as well as other duties assigned.

Primary Responsibilities:

• Define, implement, and oversee quality monitoring of the Medical Content Approval (MCA) Process
• Conducts quality monitoring of the MCA process and partners with the Global Medical Affairs Organization (GMAO) functions that also do monitoring in execution of Medical Affairs Business Oversight Plan.
• Performs routine risk assessments, including running reports, analyze trends, documenting deviations.
• Maintain and improved quality system components. For example keeping procedures, functional job aids, templates, and knowledge sources current
• Summarize data to facilitate actionable outcomes.
• Be a thought partner with the MCA strategic leads to ideate and develop effective solutions and pull through training.
• Partner with MCA strategic lead to improve usability of procedures, job aids, and knowledge sources for end users (AI, searchability, tagging, version control).
• Act as a triage for business partners to respond to questions and escalations related to Medical Affairs content quality processes, resources, systems, and training needs.
• Improved cycle time and first-pass yield for content reviews.
• Reduction in rework and repeated questions from business partners.
• High adoption and comprehension of training materials.
• Stakeholder satisfaction with process clarity and support.

Qualifications:

• Bachelor’s degree in scientific or health sciences discipline.
• At least 1 year of pharmaceutical or healthcare industry experience.
• Strong attention to detail and quality mindset.
• Excellent written and verbal communication skills in English
• Proficiency with quality systems and documentation tools (e.g., Veeva Vault, Workfront, Power BI).
• Experience in Medical Affairs, Regulatory, or Quality Assurance.
• Highly motivated and ability to work independently and collaboratively across teams.
• High learning agility and comfort with ambiguity and change.
• Ability to work in office at least 3 days per week (Location: Indianapolis-based)
• Demonstrated strength and proactive approach in problem-solving skills
• Operates with speed and efficiency
• Strong project management and organizational skills including ability to prioritize multitask and manage multifaceted projects
• Proficiency in Microsoft Office Suite of services
• Demonstrated success working across multiple geographies, time zones, business units and/or molecules or similar complexity
• Consistently demonstrates elevated emotional intelligence

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