Principal Medical Writer at ICON Strategic Solutions
Job Description
As a Principal Medical Writer you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
Principal Medical Writer independently authors study level documents (collaborating with the team), implements project level data presentation and messaging standards for assigned documents, validates individual study protocol design and clinical study report (CSR) key messages based on the strategy provided.
What You Will Be Doing
Drives the design of all assigned project level submission documents in support of the Clinical Development Plan (CDP)
Validates the individual study protocol design and clinical study report (CSR) key messages.
Contributes to the project level data presentation strategy and messaging standards
Authors other clinical regulatory documents, as required such as IND, NDA/MAA/BLA, Clinical Overviews, Clinical Summary of efficacy & Integrated summary of efficacy, Clinical Summary of Safety
Mentors Senior Scientific Medical Writers and Scientific Medical Writers in developing expertise in writing clinical, regulatory and submission documents.
You Are
A Master’s degree in the life sciences and a minimum of 6 years experience in the pharmaceutical industry or a PhD in the life sciences and a minimum of 4 years experience in the pharmaceutical industry is strongly preferred.
Highly qualified candidates with a Bachelor’s degree may be considered
In all cases, the candidate should have at least 5 years experience in regulatory medical writing, 3 of which should be in writing the submission documents (Safety Summaries, Efficacy Summaries, Clinical Overviews, etc.), preferably in the area of oncology.
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
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.
