Senior Medical Writer
Join a world-leading clinical research organization and leverage your expertise in medical writing to drive regulatory success.
Key Responsibilities:
1. Regulatory Document Development: Prepare, write, edit, and review high-quality documents for submission to regulatory agencies and health authorities, ensuring compliance with regulations and scientific principles.
2. Project Management: Participate in project management for compound programs and regulatory affairs initiatives, guaranteeing accurate and timely completion of regulatory submissions.
3. Collaboration and Communication: Communicate deliverables, timelines, and milestones to team members, collaborating closely with cross-functional teams to develop strategic content for target documents.
4. Scientific Data Interpretation: Understand, interpret, and assimilate complex scientific and research data, ensuring documentation meets regulatory requirements and is of high quality.
5. Quality Control: Assist in the review, approval, and quality control of regulatory documents, resolving content issues and facilitating review meetings.
6. Leadership Communication: Maintain open communication with leadership regarding project timelines and resource needs.
7. Content Standards: Follow applicable conventions, grammar, and formatting standards per ICH and other guidelines.
8. Process Improvement: Contribute to process improvements in tactical document production.
About You:
A Bachelor's degree is required, with relevant medical writing experience. A Bachelor of Science is preferred, or a Bachelor of Arts in English or Communications with significant science experience. An advanced degree (e.g., MS, PharmD, PhD, MD) is preferred. Certification from AMWA or similar is advantageous.
Minimum of 2 years of relevant industry experience in medical/regulatory writing, clinical research, or related areas.
Strong content writing skills, knowledge of clinical development regulations, and familiarity with statistical concepts are preferred. Excellent communication, attention to detail, and ability to interpret scientific content are essential.
Knowledge of US and international regulatory requirements, CTD templates, electronic document management systems, and IT tools is required. Proficiency in Windows-based software is expected.
About ICON:
We value our people and strive to build a diverse culture that rewards high performance and nurtures talent. We offer a competitive salary, leave entitlements, health insurance, retirement plans, and wellness programs.
We are committed to inclusion and providing an accessible environment for all candidates. We consider all qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
If you're interested but unsure if you meet all requirements, we encourage you to apply.