Medical Writing & Pharma

Project manager with laptop, phone, and planner

What Does a Regulatory Project Manager Do?

By Alex Olinger / August 31, 2022 / Comments Off on What Does a Regulatory Project Manager Do?

If you work for a team that tackles complex tasks, you are likely familiar with the benefits of having a project manager. Project managers ensure that the team achieves its goals within the given budget and time constraints. But do you know what a regulatory project manager is, and how their specialized expertise can help…

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Headshots of Katelyn and Alex

Meet Synterex’s 2022 Medical Writing Internship/Fellowship Recipients

By Alex Olinger / June 22, 2022 / Comments Off on Meet Synterex’s 2022 Medical Writing Internship/Fellowship Recipients

Each year, Synterex is proud to welcome students and postgrads to a medical writing internship or fellowship. Our current intern, Alex, and our current fellow, Katelyn, answer some questions about the experience so far. What is your educational background? Alex: I am a rising senior at Clark University, currently studying for a major in Biology…

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Key Takeaways for the Medical Writer from FDA’s Public Meeting: Supporting the Future of Rare Disease Product Development

By Jeanette Towles / February 24, 2020 / Comments Off on Key Takeaways for the Medical Writer from FDA’s Public Meeting: Supporting the Future of Rare Disease Product Development

FDA’s public meeting on February 24th left no uncertainty as to the future direction of drug development in rare disease: Patient-centric approaches that incorporate patient and caregiver input at all levels to ensure that clinical trial endpoints are robust and meaningful; and Utilization of patient data (registries, cases, natural history, and real world evidence) to…

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Defining ‘Medical Writer’ in a Job Description When the Role Defies Definition

By Jeanette Towles / February 10, 2020 / Comments Off on Defining ‘Medical Writer’ in a Job Description When the Role Defies Definition

When you look at job descriptions for medical writers, have you noticed that, regardless of the size of the hiring company, you end up with an array of interpretations of the role? Here are some examples: Medical writers may or may not write briefing books, write or review labels, or assist in regulatory responses Medical…

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