Medical and Scientific Writer II

📌 Core Information

🔹 Job Title: Medical and Scientific Writer II

🔹 Company: ICON plc

🔹 Location: Dublin, Ireland

🔹 Job Type: Full-Time, Hybrid

🔹 Category: Medical & Scientific

🔹 Date Posted: May 1, 2025

🔹 Experience Level: 2-5 years

🔹 Remote Status: On-site with hybrid flexibility

🚀 Job Overview

Key aspects of this role include:

• Collaborating with cross-functional teams to develop and prepare clinical trial documents, regulatory submissions, and scientific publications.
• Conducting literature reviews, data analysis, and interpretation of clinical trial results to support scientific manuscripts, abstracts, posters, and presentations.
• Assisting in the review and validation of clinical data to ensure accuracy, completeness, and consistency with study protocols, SOPs, and regulatory requirements.
• Participating in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, and deliverables.
• Staying up-to-date with emerging trends, scientific developments, and regulatory updates in relevant therapeutic areas.

ASSUMPTION: This role requires strong written and verbal communication skills, attention to detail, and the ability to convey complex information in a clear and concise manner. A background in life sciences, pharmacy, medicine, or a related field is preferred.

📋 Key Responsibilities

✅ Collaborating with cross-functional teams to prepare, write, and edit clinical study reports (CSRs), clinical protocols, investigator brochures (IBs), patient narratives, and other regulatory documents in compliance with internal standards and regulatory guidelines.

✅ Conducting literature reviews, data analysis, and interpretation of clinical trial results to support the development of scientific manuscripts, abstracts, posters, and presentations for publication in peer-reviewed journals and scientific conferences.

✅ Assisting in the review and validation of clinical data, ensuring accuracy, completeness, and consistency with study protocols, standard operating procedures (SOPs), and regulatory requirements.

✅ Participating in project meetings, teleconferences, and client interactions to discuss project objectives, timelines, and deliverables, while providing input and feedback on document content, format, and presentation.

✅ Keeping abreast of emerging trends, scientific developments, and regulatory updates in relevant therapeutic areas, and applying knowledge of medical writing principles and best practices to support the successful execution of clinical research projects.

ASSUMPTION: The role may require occasional overtime to meet project deadlines, and the successful candidate should be comfortable working in a dynamic, fast-paced environment.

🎯 Required Qualifications

Education: Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field

Experience: A minimum of 3 years of experience in medical writing within the pharmaceutical, biotechnology, or contract research organization (CRO) industry

Required Skills:

• Proficient in scientific and medical terminology
• Excellent written and verbal communication skills
• Strong analytical and critical thinking skills
• Familiarity with regulatory requirements, industry guidelines, and publication standards
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

Preferred Skills:

• Familiarity with document management systems, reference management software, and statistical analysis tools

ASSUMPTION: Candidates with relevant industry experience and a proven track record of successful medical writing will be given priority.

💰 Compensation & Benefits

Salary Range: €45,000 - €60,000 per annum (Estimated, based on industry standards for the role, experience level, and location)

Benefits:

• Various annual leave entitlements
• Range of health insurance offerings
• Competitive retirement planning offerings
• Global Employee Assistance Programme
• Life assurance
• Flexible country-specific optional benefits

Working Hours: Full-time, typically 9:00 AM - 5:30 PM with flexibility for hybrid work arrangement

ASSUMPTION: The salary range provided is an estimate based on industry standards for the role, experience level, and location. Actual compensation may vary based on qualifications, experience, and other factors.

📌 Applicant Insights

🔍 Company Context

Industry: ICON plc operates in the biotechnology research industry, focusing on healthcare intelligence and clinical research services.

Company Size: ICON plc is a large company with over 10,000 employees globally, providing ample opportunities for collaboration and growth.

Founded: ICON plc was founded in Dublin, Ireland in 1990, with a mission to help clients accelerate the development of drugs and devices that save lives and improve quality of life.

Company Description:

• ICON plc offers a full range of consulting, development, and commercialisation services from a global network of offices in 53 countries.
• The company focuses its innovation on reducing time to market, reducing cost, and increasing quality for its clients.
• ICON plc has extensive experience in a broad range of therapeutic areas.

Company Specialties:

• Medical Device
• Therapeutics
• Government and Public Health Solutions
• Clinical Research Services
• Commercialisation and Outcomes
• Oncology
• Value Based Healthcare
• Clinical Trials
• Patient Recruitment
• Innovation
• Regulatory Affairs
• Strategic Consulting
• Medical Affairs
• Global Patient Insights & Engagement

Company Website: http://www.iconplc.com

ASSUMPTION: ICON plc's extensive global presence and diverse service offerings provide ample opportunities for career growth and development.

📊 Role Analysis

Career Level: This role is at the mid-level career stage, requiring a balance of technical expertise and project management skills.

Reporting Structure: The Medical and Scientific Writer II will report directly to the Medical Writing Manager or a similar role within the organization.

Work Arrangement: This role offers a hybrid work arrangement, with a combination of on-site and remote work.

Growth Opportunities:

• Progression to Senior Medical Writer or other leadership roles within the Medical Writing department
• Expansion into related fields, such as regulatory affairs, medical affairs, or clinical operations
• Opportunities to work on diverse projects and gain exposure to various therapeutic areas

ASSUMPTION: Successful candidates will have the opportunity to grow both personally and professionally within ICON plc's dynamic and supportive work environment.

🌍 Location & Work Environment

Office Type: ICON plc's Dublin office is a modern, collaborative workspace with state-of-the-art facilities and amenities.

Office Location(s): South County Business Park, Leopardstown, Dublin, Ireland

Geographic Context:

• Dublin is the capital and largest city of Ireland, known for its vibrant culture, rich history, and diverse neighborhoods.
• The city is home to a thriving tech industry, with numerous multinational corporations and startups calling it home.
• Dublin offers a high quality of life, with excellent education, healthcare, and recreational opportunities.

Work Schedule: The hybrid work arrangement allows for flexible scheduling, with a combination of on-site and remote workdays.

ASSUMPTION: The successful candidate should be comfortable working in a dynamic, fast-paced office environment and be able to manage their time effectively when working remotely.

💼 Interview & Application Insights

Typical Process:

• Online application submission
• Phone or video screening
• On-site or virtual interview with the hiring manager and/or team members
• Final round interview with senior leadership
• Background check and offer extension

Key Assessment Areas:

• Writing and editing skills
• Knowledge of medical writing principles and best practices
• Understanding of clinical trial documents, regulatory submissions, and scientific publications
• Ability to work collaboratively with cross-functional teams
• Adaptability to working in a dynamic, fast-paced environment

Application Tips:

• Tailor your resume and cover letter to highlight your relevant medical writing experience and skills
• Provide examples of your medical writing work, if available
• Prepare for behavioral and situational interview questions that assess your problem-solving skills, attention to detail, and ability to work under pressure
• Research ICON plc's company culture and values to demonstrate your fit for the organization

ATS Keywords: Medical Writing, Clinical Trial Documents, Regulatory Submissions, Scientific Publications, Data Analysis, Literature Reviews, Attention to Detail, Communication Skills, Analytical Skills, Critical Thinking, Regulatory Requirements, Microsoft Office Suite

ASSUMPTION: The interview process may vary depending on the specific role and the candidate's experience level. It is essential to be prepared for a range of interview formats and questions.

🛠️ Tools & Technologies

• Microsoft Office Suite (Word, Excel, PowerPoint)
• Document management systems
• Reference management software
• Statistical analysis tools

ASSUMPTION: The successful candidate should be comfortable using various tools and technologies to support their medical writing work.

👔 Cultural Fit Considerations

Company Values:

• Patient Focus
• Integrity
• Collaboration
• Innovation
• Expertise
• Quality

Work Style:

• Dynamic and fast-paced work environment
• Collaborative and team-oriented culture
• Focus on continuous learning and professional development
• Opportunities for growth and advancement

Self-Assessment Questions:

• How do you ensure the accuracy and completeness of clinical data in your medical writing work?
• Can you provide an example of a time when you had to manage multiple projects or deadlines simultaneously?
• How do you approach working with cross-functional teams to ensure the successful execution of clinical research projects?

ASSUMPTION: Successful candidates will demonstrate a strong cultural fit with ICON plc's values and work style, as well as a commitment to the company's mission and vision.

⚠️ Potential Challenges

• The role may require occasional overtime to meet project deadlines
• The dynamic and fast-paced work environment may be challenging for candidates who prefer a more structured or predictable work setting
• The successful candidate should be comfortable working in a collaborative, team-oriented culture and be able to manage their time effectively when working remotely
• The role may require travel to attend client meetings, project kick-offs, or other events

ASSUMPTION: The successful candidate should be adaptable, resilient, and able to thrive in a dynamic, fast-paced work environment.

📈 Similar Roles Comparison

• Medical Writer vs. Medical Writer II: The Medical Writer II role typically requires more experience, responsibility, and leadership skills than the Medical Writer role
• Medical Writing vs. Regulatory Affairs: Medical Writing focuses on the development and preparation of clinical trial documents, regulatory submissions, and scientific publications, while Regulatory Affairs involves navigating regulatory requirements and ensuring compliance with regulatory guidelines
• Career Path: Medical Writer II → Senior Medical Writer → Medical Writing Manager → Director of Medical Writing

ASSUMPTION: The Medical and Scientific Writer II role is a critical step in the career progression of medical writing professionals, providing valuable experience and opportunities for growth and advancement.

📝 Sample Projects

• Preparing a clinical study report (CSR) for a Phase III clinical trial in the oncology therapeutic area
• Editing and finalizing a regulatory submission for a new drug application (NDA) in the rare diseases therapeutic area
• Conducting a literature review and data analysis to support the development of a scientific manuscript on the safety and efficacy of a new medical device

ASSUMPTION: The successful candidate should have experience working on diverse projects and be able to apply their medical writing skills to various therapeutic areas and document types.

❓ Key Questions to Ask During Interview

• Can you describe the typical workload and project pipeline for this role?
• How does the Medical Writing department collaborate with other departments within ICON plc?
• What opportunities are there for professional development and growth within the Medical Writing department?
• How does ICON plc support work-life balance for its employees?
• Can you provide an example of a recent project that the Medical Writing department has worked on, and how it contributed to ICON plc's mission and vision?

ASSUMPTION: Asking thoughtful, insightful questions demonstrates your interest in the role and commitment to ICON plc's success.

📌 Next Steps for Applicants

To apply for this position:

• Submit your application through this link
• Tailor your resume and cover letter to highlight your relevant medical writing experience and skills, using the ATS keywords provided
• Prepare for behavioral and situational interview questions that assess your problem-solving skills, attention to detail, and ability to work under pressure
• Research ICON plc's company culture and values to demonstrate your fit for the organization
• Follow up with the hiring manager or HR representative within one week of submitting your application to express your interest in the role

⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.