Medical writers play a pivotal role in regulatory submission writing - but they're just one process component.
Regulatory submission writing is a complex and expensive process beginning in preclinical development and continuing even after product approval. Comprising clinical and non-clinical study reports, manufacturing, and administrative information, these documents can span thousands of pages. They must meet stringent regulatory requirements and deadlines to ensure product safety and efficacy. Whether produced internally or outsourced, medical writing teams work within a cross-functional framework and often with external stakeholders. Project management is crucial at every stage, from initial planning to supporting health authority interactions and continuing through the product's lifecycle.
The challenges faced
Over the past two decades, the role of lead medical writers has expanded significantly. Beyond writing, they must now manage project plans, juggle writing resources, coordinate with subject matter experts, develop messaging plans, and ensure quality control. These responsibilities consume substantial time, diverting their focus from their core task - producing high-quality documents.
The role of a project manager
This is where the project manager comes in to alleviate these burdens. This role, designed to support medical writers, involves managing logistical and overarching concerns without directly authoring documents. Project managers can help at each study stage, fostering unity and collaboration within the team. They work closely with lead medical writers to ensure everything runs smoothly.
Project managers help define projects with clear objectives, timelines, budgets, resourcing, and metrics. Their leadership skills, including relationship-building, critical thinking, budgeting, decision-making, and problem-solving, are pivotal for efficient project execution. They act as conductors, guiding the project team through potential obstacles and strategizing solutions.
Effective communication and coordination
Project managers maintain open communication lines within the team, participating in key meetings including kick-off and comment resolution meetings. They set goals and priorities early on. They help coordinate team dynamics, identify training gaps, and mentor new team members. Some of the key areas they can help include:
Timelines: Creating and maintaining timeliness by monitoring progress, flagging scope changes, and developing contingency plans to keep projects on track.
Budget: Tracking budget status by regular budget reviews to help identify efficiency areas and address cost impacts from scope changes.
Resources: Maintaining a comprehensive resourcing plan, addressing bottlenecks, and managing workload balance to prevent burnout.
Communication: Encouraging clear communication to ensure team members are informed about project details, timelines, and pending deliverables.
Milestones: Have regular milestone check-ins and ensure everyone is informed throughout.
Risk Management: Identifying and understanding risks, addressing concerns, and working with teams to overcome obstacles, ensuring timely submissions.
Where do we come in?
Here at Morula Health, our team of experienced project managers assist our network of 30+ medical writers at every stage of the project. Our team benefits from the ability to work independently, whilst still receiving comprehensive support from our in-house project management team. Our project managers ensure your project is kept on track, on time, and on budget with weekly reports and milestone check-ins.
Conclusion
Adding a project manager’s skillset to medical writing activities enhances team effectiveness. Their ability to engage stakeholders, manage priorities, build consensus, and foster a collaborative environment ensures project success. As projects grow more complex, their contribution becomes invaluable to medical writing teams.
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