Job Title: Senior Medical Writer
Location: United States (Remote)
About ICON plc:
ICON plc is the world’s largest and most comprehensive clinical research organization, powered by healthcare intelligence. We are focused on building a diverse, high-performing team to support our mission of accelerating the development of drugs and devices that save lives. We are hiring a Senior Medical Writer to contribute strategic medical and regulatory content and lead scientific documentation processes for regulatory submissions.
Role Summary:
As a Senior Medical Writer, you will be responsible for the preparation, review, and submission of regulatory documents. Your expertise will shape the scientific messaging of key clinical deliverables, working cross-functionally with global teams to ensure compliance with regulatory requirements and high-quality writing standards.
Key Responsibilities:
Prepare, write, review, and edit scientific and regulatory documents (e.g., clinical study reports, protocols, investigator brochures) in alignment with ICH and global guidelines.
Represent Regulatory Scientific Writing (RSW) in project teams and interface with Global Regulatory Project Teams (GRPT), clinical, pharmacovigilance, and other stakeholders.
Collaborate with teams to determine deliverables, timelines, and strategic messaging of submission documents.
Interpret scientific data and literature, ensuring accuracy, clarity, and compliance in all regulatory documentation.
Ensure quality and completeness of content; challenge scientific conclusions when necessary; compile required documentation.
Oversee document review processes, including QC checks, review meetings, and resolution of content issues.
Track project milestones, communicate progress, and escalate resource needs as appropriate.
Ensure formatting, grammar, and terminology meet internal SOPs and international regulatory standards.
Contribute to the development and refinement of internal medical writing processes and templates.
Qualifications:
Bachelor’s degree in life sciences, English, Communications, or a related field is required. A Bachelor of Science is preferred.
Advanced degree (e.g., MS, PharmD, PhD, MD) is preferred and may substitute for years of experience.
AMWA certification or equivalent in Pharmaceutical Writing is desirable.
Minimum of 2 years’ experience in regulatory/medical writing or related functions (e.g., clinical research, regulatory affairs).
Demonstrated ability to write clinical and regulatory documents with clarity, consistency, and scientific accuracy.
Strong understanding of regulatory documentation requirements in the U.S. and internationally.
Proficiency with Common Technical Document (CTD) structure, document management systems, and statistical data interpretation.
Excellent oral and written communication skills with high attention to detail.
Knowledge of Microsoft Office tools and document formatting in a Windows environment.
Work Arrangement:
Full-time remote role (United States-based).
Compensation & Benefits:
Competitive base salary with performance incentives.
Comprehensive healthcare options for employees and families.
Retirement planning benefits tailored to individual needs.
Global Employee Assistance Programme (TELUS Health) with 24/7 confidential support.
Life insurance and flexible benefits, such as:
Childcare vouchers
Bike-to-work programs
Gym membership discounts
Health assessments and wellness subsidies
Subsidized travel and commute solutions
Diversity & Inclusion:
ICON values inclusion, belonging, and equal opportunity. We foster an environment free of discrimination and harassment, and welcome all qualified applicants regardless of background or identity.
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