Description
As a Medical Writer II, you will independently develop high-quality clinical and scientific documents and work closely with scientific, laboratory, clinical, quality, and other cross-functional teams to accurately communicate clinical and laboratory testing data.
You will take responsibility for assigned medical writing deliverables, applying your scientific and writing expertise to ensure accuracy, clarity, quality, and timely completion.
Key Responsibilities Include:
- Preparing, writing, editing, and reviewing clinical and scientific documents, including end-of-study reports, laboratory sample testing plans, SOPs, protocols, and other supporting documents.
- Reviewing, interpreting, and summarizing clinical and laboratory testing data accurately and concisely within required reports, formats, and templates.
- Ensuring document accuracy, completeness, consistency, and alignment with study requirements, internal SOPs, and applicable regulatory requirements.
- Collaborating with clinical testing laboratories, scientific subject matter experts, Data Management, Regulatory Affairs, Medical Affairs, Project Management, and Quality Assurance to obtain and clarify information required for document development.
- Participating in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, data, and deliverables and to provide scientific and editorial input on document content and presentation.
- Conducting and coordinating quality-control reviews to ensure scientific accuracy, data integrity, formatting consistency, and overall document quality.
- Managing assigned writing activities and priorities to meet project timelines and deliverables.
- Providing guidance and support to junior medical writers, as appropriate.
- Maintaining awareness of relevant scientific developments, clinical research practices, regulatory requirements, and industry guidelines.
Your Profile You will bring a strong scientific foundation and relevant medical or scientific writing experience, with the ability to work independently, interpret complex information, and communicate clinical and laboratory data clearly and accurately.
Required Qualifications and Experience:
- Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related scientific, clinical, or regulatory field required; an advanced degree (e.g., MSc, PhD, PharmD, MD) is preferred.
- A minimum of 3 years of relevant medical or scientific writing experience within the pharmaceutical, biotechnology, CRO, clinical research, or clinical laboratory industry is required.
- Excellent scientific writing, editing, and proofreading skills, with strong knowledge of scientific and medical terminology and the ability to communicate complex information clearly and concisely.
- Strong analytical and critical-thinking skills, including the ability to review, interpret, and summarize clinical, scientific, and laboratory data and identify key findings, trends, and inconsistencies.
- Familiarity with clinical research processes, applicable regulatory requirements, industry guidelines, and scientific documentation standards.
- Strong attention to detail and a demonstrated commitment to scientific and data accuracy.
- Ability to work independently while collaborating effectively with scientific, laboratory, clinical, regulatory, quality, and project teams.
- Ability to manage multiple projects and priorities within a deadline-driven environment.
- Strong interpersonal and communication skills, including the ability to interact effectively with internal stakeholders and clients.
- Proficiency with Microsoft Office applications, particularly Word, and familiarity with PDF editing, document publishing, and electronic document management systems.
- Experience with clinical laboratory testing, biomarker data, or laboratory-generated reports is preferred.
Rewards & Benefits ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- Competitive base salary and performance related incentives
- Health and wellbeing programmes including medical, dental, and vision coverage where applicable
- Retirement and pension plans
- Life assurance and disability coverage
- Employee assistance programmes and wellbeing resources
- Learning and development opportunities through structured training and career pathways