As a Senior Medical Writer you will be joining the world's largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Prepare, write, edit, and review high-quality, clearly-messaged documents founded in regulation and supported by the science for submission to regulatory agencies and health authorities. When necessary, serve as the RSW representative on project teams with the GRPT members, and functional area contributors (e.g., Clinical, Pharmacovigilance, CPPM, etc.) and other RSW staff.
Participate in project management for compound programs and/or RSW projects and initiatives. Ensure accurate and timely completion/delivery of information and review of regulatory submissions.
Communicate deliverables needed and corresponding writing processes, project timelines, and milestones to team members. In pursuit of this responsibility the Senior Writer is to work closely with GRPT members on the strategic content of target documents.
Understand, assimilate, and interpret sources of information (e.g., scientific literature, internal and external studies, research documentation, charts, graphs, and tables, and previous interactions with healthcare authorities) with appropriate guidance/direction from GRPT team and/or authors/key opinion leaders. Ensure required documentation is obtained. Explain and prepare data in a manner consistent with regulatory requirements. Confirm quality and completeness of information to be presented. Challenge conclusions when necessary. Convert relevant data and information into a form that meets regulatory document requirements. Ensure all regulatory electronic document deliverables are processed and compiled in alignment with timelines.
Assist with the coordination of the review, approval, QC, and other activities involved in the production of regulatory documents. Assist in the arrangement and conduct of review meetings with the team. Resolve document content issues and questions arising during the writing process.
Assist with regular communication with RSW leadership on timeline/milestone progress for any assigned program. Assess resource needs as timelines progress and communicate any additional resource requests to the manager.
Understand/comply with appropriate conventions, proper grammar usage, and correct format requirements per ICH and other governing bodies by following applicable divisional guidelines, templates, and SOPs.
Assist in the design and implementation of tactical process improvements.
You are:
A Bachelors's degree is required with relevant medical writing experience, A Bachelor of Science is preferred, or Bachelor of Arts in English or Communications with significant relevant science experience. A relevant advanced degree (e.g., MS, PharmD, PhD, MD) is preferred, and higher education may substitute for years of experience. American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing.
Minimum of 2 years of relevant industry experience in medical/regulatory writing in the healthcare industry or academia, or in a related area such as quality, regulatory, clinical research, or product support/R&D.
High-level content writing experience and experience with clinical development regulatory documents preferred, with working knowledge of statistical concepts and techniques. Excellent written and oral communication skills. Capable of assimilating and interpreting scientific content with adeptness in ability to translate for appropriate audience. Excellent attention to detail and superior ability with respect to consistency, clarity and accuracy.
Knowledge of US and international regulations, requirements and guidance associated with regulatory document preparation and submissions and ability to advise teams regarding compliance with regulations.
Knowledge of Common Technical Document content templates, electronic document management systems and information technology.
Excellent working knowledge of software programs in Windows environment.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent.
In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.
Our benefits examples include:
Various annual leave entitlements
A range of health insurance offerings to suit you and your family's needs
Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead
Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being
Life assurance
Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, inclusion & belonging are fundamental to our culture and values. We're dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.
https://careers.iconplc.com/reasonable-accommodations
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
