RWE Senior Medical Writer
ICON plc
Summary
As a Senior Medical Writer, your primary responsibility will be to provide scientific and medical/clinical writing support as part of a team dedicated to late-phase projects, servicing an assigned client. While the ability to work independently is key, the Senior Medical Writer will work closely with the ICON team and other members of the client account team to help ensure the timely delivery of high-quality and scientifically/medically accurate assigned projects. This writer will work with Peri- and Post-Approval Safety studies and RWE studies.
Job description
The Role
- Responsible for writing and reviewing study documents such as Protocol, Synopsis, Informed Consent, Data Collection Documents and Study Report, etc.
- Responsible for developing scientific communication such as abstract, poster, manuscript, etc.
- Responsible for performing quality control for medical writing deliverables
- Responsible for interpreting statistical results and for soliciting statistician input for developing study reports, abstracts, manuscripts, and other documents as required
- Participating in the improvement of the quality assurance system
- Responsible for participating in bid-defence presentations representing medical writing activities
What you need
- Advanced degree in a scientific discipline, PharmD
- 5+ years of professional experience in Medical Writing at a pharmaceutical, biotechnology, CRO or other health care setting
- Proven knowledge of ICH/GCP and GPP guidelines or other meaningful guidelines or industry standard
- Outstanding written and verbal interpersonal skills
- Good computer literacy
- Ability to work effectively and cooperatively with cross-functional teams
Requirements
- Advanced degree in a scientific discipline, PharmD
- 5+ years of professional experience in Medical Writing at a pharmaceutical, biotechnology, CRO or other health care setting
- Proven knowledge of ICH/GCP and GPP guidelines or other meaningful guidelines or industry standard
- Outstanding written and verbal interpersonal skills
- Good computer literacy
- Ability to work effectively and cooperatively with cross-functional teams
Benefits
- Competitive base salary
- Performance related incentives
- Medical, Dental & Vision
- Retirement and pension plans
- Life assurance
- Disability coverage
- Employee assistance programmes
- Wellbeing resources
- Learning and development opportunities
Company overview
ICON plc is a global leader in clinical research and healthcare intelligence, founded in Dublin, Ireland in 1990. As one of the world's largest contract research organizations (CROs), ICON provides comprehensive outsourced development services to pharmaceutical, biotechnology, and medical device companies worldwide. The company operates in 55 countries with approximately 41,900 employees, offering end-to-end solutions that span the entire product development lifecycle. ICON's service portfolio includes clinical research services, adaptive trials, biosimilars, commercialization and outcomes consulting, medical imaging, laboratory services, and strategic support for traditional and digital health technologies. The company specializes in therapeutic areas such as oncology, cardiovascular diseases, central nervous system disorders, rare diseases, and women's health. With its 2021 acquisition of PRA Health Sciences, ICON significantly expanded its capabilities and market position, becoming a dominant force in the global CRO industry. The company is publicly traded on NASDAQ under the ticker ICLR and reported $8.28 billion in revenue for 2024.