Gregory P.

Working on a range of projects with multiple clients across regulatory and medical communications fields.

Managed a team of medical writers in the delivery of medical education content. Led on proposal development and delivery of educational content.

As a freelance medical writer and project manager I have developed core skills in coordinating the efforts of medical writers and other team members in producing content that exceeds client expectations. My recent experience relates to medical communications, regulatory medical writing, and medical education. Key projects, responsibilities and experience are noted in these areas:

Medical communications

I have worked on a contractual basis with a number of medical communications agencies. These roles included work on journal publications, advisory board content and medical education for pharmaceutical companies, focusing on Europe and emerging markets. This included publication of a number of white papers, consensus documents and editorial contributions to guidelines produced by medical associations.

I have worked in-house for medical communications companies on a range of communications for pharmaceutical healthcare marketing. This includes content for presentation, journals, and wider marketing materials.

Regulatory writing

My experience is principally within the domain of clinical components of drug application documents in Europe. This includes aspects of Module 2 writing and editing, with specific reference to 2.5 and 2.7.

Working on a contractual basis, I have written documents for submission to regulatory authorities inclusive of clinical development plans, clinical study reports, NDA documents (clinical overview and integrated summary of safety and efficacy) and risk management profiles. These documents were within the field of cardiovascular medicine and included data provided to both the EMA and FDA. Working as the project manager, I produced written content and directed a small team of medical writers, serving as the lead client contact.

Additional short-term contracts have included work relating to the preparation and editing of Phase I protocols through to pharmacovigilance content, inclusive of risk management plans and periodic safety update reports. I have worked both as medical writer and as project lead for these regulatory components, liaising directly with clients at all stages.

More broadly, I have consulted directly with pharmaceutical companies and medical writing firms to oversee data analysis and construction of narratives for subsequent marketing. This includes work on regulatory aspects of drug use in respiratory medicine. Furthermore, I have performed wider editing of regulatory documents and associated content for the pharmaceutical industry, streamlining content and ensuring adherence to a formal style and content guide, consistent with the expectations of regulatory bodies.

Medical education

I have worked in-house for journals, to develop e-learning tools, working as project manager and medical writer for online content. These responsibilities included liaising with clients, overseeing peer review of content, composing examination questions for physicians, and performing literature searches to guide content development. I also have extensive experience of developing training slide decks for in-house and external education purposes, targeting a range of healthcare professionals.