ICON Strategic Solutions Manager, Medical Writing in Boston, Massachusetts
As a Manager of Medical Writing you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Responsible for leading project teams in drafting report specifications, medical writing, and coordination of regulatory submissions.
Be responsible for preparation of key clinical documents for regulatory submissions and other documents not limited to below:
Clinical study protocols
Clinical study reports (CSRs)
Main Informed consent forms (ICFs)
Relative Clinical/regulatory review documents
Serves as the Medical Writing representative on product teams.
Utilizes submission templates (if available) or format/style guidelines (if available) according to related SOP.
Communicates deliverables needed and writing process to team members.
Acts as interface to resolve issues and questions arising during writing process.
Arranges and conducts review meetings with team, and coordinates responses to inquiries, questions, and deficiencies received from submission reviewers.
May oversee external vendors to provide writing service for internal AHT projects.
Master’s degree or above, majoring in medicine, pharmacy, or life science related disciplines. Publications in the international journals as the first author would be a plus.
Knowledge and understanding of the clinical research process, including ICH GCP, and FDA/EMA/NMPA guideline for clinical study.
Seven (7)+ years' experience in the role of a medical writer including experience as lead author of CSRs and NDA submissions required
Minimum 7-10 years relevant professional experience in Medical Writing, including:
Expert knowledge and understanding of requirements for writing technical sections of regulatory and/or pharmacovigilance documents and clinical study reports.
Demonstrated expertise in regulatory submissions requirements and clinical study report guidelines.
Experience working with different document management tools, i.e.. Microsoft office, and expertise with EndNote or equivalent.
Excellent communication, interpersonal, and team skills.
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.
ICON Strategic Solutions
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