ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations.

With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life.

Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The role

Due to significant growth we are hiring Senior Medical writers to be home-based anywhere in Europe or South Africa!

In this role you will have unparalleled opportunities for learning and development as no two days are the same. As part of our truly global full-service team you will enjoy the variety of working with different sponsors on various document types.

Key responsibilities include:

• Acting as a lead medical writer, producing clinical and regulatory documents as required, e.g., protocols, clinical study reports, investigator brochures, etc
• Providing scientific and medical writing consultancy to clients and colleagues
• Leading project teams in medical writing, and coordinating document preparation
• Attending and leading client meetings
• Acting as a member of process improvement and interest groups

You will have

• A bachelor’s degree in science or a health-related field (an advanced degree is preferred)
• At least 5 plus years of relevant experience in a pharmaceutical / biotechnology company / CRO
• Experience with writing key documents included in US and/or international regulatory submissions
• Experience managing medical writing projects
• Understanding of FDA / international regulations, ICH guidelines, and applicable US / international regulatory processes related to document preparation and production
• Ability to understand sponsor guidelines and requirements related to the preparation and production of regulatory documents and submissions
• Well-developed oral and written communication skills; ability to clearly present technical information within and across functional areas
• Demonstrated problem-solving and interpersonal skills that facilitate effective interactions within functional and cross-functional teams and with external providers
• Knowledge of team dynamics and ability to function as a team leader
• Demonstrated technical expertise and background in the use of medical writing templates and software (eg, PleaseReview, document and submission content management platforms, etc)

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. All qualified applicants will receive equal consideration for employment without regard to race, color, 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.