Project Data Manager - Medical Writing

Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Discover what our 29,000 employees, across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture – where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.

Job Responsibilities

Project Management & Tool Development

• Contributes to clinical documentation tool development initiatives and supports implementation timelines
• Assists in coordinating cross-functional project teams including medical writers, IT developers, and business stakeholders
• Supports vendor relationships and participates in tool customization and deployment strategies
• Contributes to AGILE/PUMA project management methodologies for documentation system implementations
• Participates in managing project deliverables and timelines for strategic tool initiatives
• Contributes to GxP documentation projects, ensuring compliance with regulatory requirements
• Participates in developing and maintaining documentation for GxP-regulated systems and processes

Training & User Enablement

• Contributes to developing and delivering comprehensive training programs for new clinical documentation tools
• Helps create user support materials, documentation, and best practice guidelines
• Supports workshops and user adoption initiatives across global teams
• Provides ongoing user support and troubleshooting for deployed systems
• Assists in coordinating user onboarding processes and change management activities

Medical Writer & Medical Writer Developer Technical Support

• Provides technical support to Medical Writers and Medical Writer Developer for automation & authoring tools and platforms
• Troubleshoots technical issues affecting medical writing workflows
• Ensures Medical Writers & Medical Writer Developers can effectively use clinical documentation tools

User Representation & Coordination

• Serves as User Representative Coordinator for clinical documentation tool initiatives
• Serves as point of contact between Business team and Digital/technical teams
• Participates in managing user testing environments and sandbox configurations for automation & authoring platforms
• Supports communications between end-users and technical development teams
• Contributes to delivering presentations and coordinating stakeholder engagement activities
• Gathers and translates user requirements into functional and technical specifications

Strategic Analysis & Technical Evaluation

• Evaluates technical solutions and tools for clinical documentation needs
• Conducts technical assessments of platforms and vendor capabilities
• Provides strategic recommendations for tool selection and implementation
• Supports decision-making processes for technology adoption
• Contributes to developing business intelligence solutions and KPIs for project monitoring and strategic decision-making
• Helps create analysis files for executive review and organizational planning

Tool Development & Deployment

• Contributes to tool development initiatives and deployment strategies for clinical documentation platforms
• Supports implementation timelines and user onboarding processes across global operations
• Participates in managing sandbox environments and testing protocols for new system implementations
• Assists in coordinating with vendors and technical teams for tool customization and integration
• Contributes to optimization of authoring tools and content reuse capabilities

Get to know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients.

No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.