Principal Medical Writer

As a Principal Medical Writer you will Lead, manage, and coordinate all internal and external writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally.

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

What you will be doing:

• Lead, manage, and coordinate all internal and external writing activities associated with
the preparation, compilation, and submission of applications to regulatory authorities
globally.
• Oversee and manage internal and contract medical writing resources as required to ensure
timely completion of assigned projects.
• Develop regulatory documents for submission to regulatory agencies globally, in
accordance with ICH and other global guidelines, standards and processes, and AMA
Medical Writing styles, as applicable, in adherence with study/project timelines and
corporate objectives.
• Actively participate in study and/or project team meetings to provide input regarding
medical writing deliverables, timelines, and any process(es) needed for the completion of
regulatory documents.
• Administrate as appropriate, the receipt, collation, and incorporation of review comments
needed for the completion of regulatory documents.
• Lead or participate in defining and writing standard operating procedures and working
practices which will allow the effective and efficient preparation of quality.
• Lead or participate in cross-functional process improvement initiatives.
• Mentor more junior medical writing staff

Qualifications :

- A Bachelor's degree in a life science discipline, with Master's degree in life science
discipline preferred.
• At least 6 years writing experience in the biopharmaceutical/CRO industry required.

- Oncology experience preferred 
• Proficient understanding and knowledge of domestic and international regulatory
requirements required and knowledge of therapeutic areas in all phases of clinical
development desired.
• Proficiency in organizing and communicating clinical information necessary.
• Strong communications, organizational, time management, and project management
skills are required.

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

ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 or submit a request here.

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.