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Principal Medical Writer
3 months ago
The Principal Medical Writer prepares complex, high-quality clinical, regulatory and safety documents in collaboration with cross-functional study teams, contributes strategically and scientifically at the project and/or study team level, manages and provides mentoring and support to other medical writers, develops and streamlines workflows and processes across the research, and collaborates with internal and external stakeholders to support clinical/regulatory/safety documentation objectives in multiple therapeutic areas.
The Principal Medical Writer may independently serve as primary author of complex writings, e.g. scientific or business publications, important clinical documents (e.g., pivotal Phase 3 protocols and reports) and lead submission document development.The incumbent may provide medical writing project management support for multiple compounds and multiple projects throughout client's clinical development phases.
Typical duties would include substantive preparation, editing, and review of regulatory and/or clinical documents, project management/medical writer-allocation planning across client's research and development projects for the MW team, researching and use of published study reports for various investigational compounds for multiple therapeutic indications, independently preparing medical writing documents as needed, and coordinating the publication of key nonclinical, early clinical, and clinical scientific data through peer-reviewed journals and forums.
The role can be based anywhere in Europe or UK
Core Responsibilities:
- Writes, reviews, and edits clinical and/or regulatory documents (e.g., protocol, protocol amendments, preclinical and clinical study reports, Investigator's Brochures, IB addendums, package inserts, clinical and nonclinical modules of INDs, NDAs, and MAAs, Briefing Books, annual reports, DSURs, IMPDs) and other documents in collaboration with crossfunctional area teams and per the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH), the National Institute of Health (NIH), and regulatory guidances/standards.
- May also prepare publications (scientific manuscripts, abstracts, poster presentations, oral presentations).
- Represents medical writing function as an integrated member of clinical study teams.
- Drives document writing and review processes.
- Develops and maintains timelines for document generation, revision, and completion, with collaboration with other study team members
- Coordinates and manages review cycles, incorporates team comments, and leads discussions on document revision and finalization
- Develops and maintains SOPs for the function and writing tools, such as templates and style manuals, and provides training within the department and across departments
- Works to develop regulatory document templates, formatting, and guidelines for clinical documentation.
What do you need to have:
- BA/BS required, preferably in a related scientific discipline.
- Advanced scientific degree (MS, PharmD, PhD) is preferred.
- 5+ years of healthcare experience is required.
- 3+ years pharmaceutical or pharmaceutical Clinical Research Organization (CRO) medical writing experience is required, ideally experience that is welldocumented.
- Handson Clinical Research experience is a plus.
- Experience in a Sr. Medical Writer or lead role, including project/resource allocation experience.
- Knowledge of clinical research documentation, related regulations and guidelines (FDA, EMEA, ICH, NIH), AMA writing style, use of Word templates, and familiarity with GCP guidelines. An attentive, fast learner who is willing to continue to gain regulatory MW expertise and implement MW and company's working processes and SOPs
- Outstanding interpersonal, written and oral communication skills, an ability to work in collaboration with a crossfunctional study team, able to establish rapport with all functional leaders, experts, and colleagues
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Benefits of Working in ICON:
Our success depends on the knowledge, capabilities and quality of our people.
That's why we are committed to developing our employees in a continuous learning culture - one where we challenge you with engaging work and where every experience adds to your professional development.
At ICON, our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs.
In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.
ICON, including subsidiaries, is an equal opportunity and inclusive employer and is committed to providing a workplace free of discrimination and harassment.
