Principal Medical Writer

As a Principal Medical Writeryou will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

This position is responsible for the development of clinical documents for submissions to
regulatory authorities globally. Works directly with multidisciplinary project team members
with the goal of writing scientifically valid, complete, and consistent documents such as clinical
study protocols and amendments, clinical study reports (CSRs), Investigator’s Brochures (IBs),
clinical Module 2 summary documents, and other regulatory documents. Has broad
understanding of clinical research processes and global regulatory document standards. The
Principal Medical Writer will oversee the medical writing activities of multiple compounds and
will serve as lead writer on major submissions. Demonstrates strong interpersonal and
organizational skills and can interpret and describe scientific data. This position reports to the
Head of Medical Writing.

Responsibilities:

• Lead, manage, and coordinate all internal and external writing activities associated with
  the preparation, compilation, and submission of applications to regulatory authorities
  
• 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 improvement initiatives.
• Mentor more junior medical writing staff

You are:
Minimum Requirements:

• 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.
• 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.
• Proficient in MS Word. and experience with template systems (eg, StartingPoint).
• Experience with an electronic document management system (eg, MasterControl, Documentum) and use of templates preferred.
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.

Why 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.

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.

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.

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.

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