📌 Core Information
🔹 Job Title: Contract Medical Writer - 12 month contract - Ireland
🔹 Company: ProPharma
🔹 Location: Dublin, Ireland
🔹 Job Type: Contract
🔹 Category: Medical Writing
🔹 Date Posted: April 10, 2025
🔹 Experience Level: 2-5 years
🔹 Remote Status: Fully Remote
🚀 Job Overview
Key aspects of this role include:
- Writing and editing high-quality regulatory documents
- Adhering to established regulatory standards and guidelines
- Collaborating with cross-functional teams and clients
- Managing project timelines and deliverables
ASSUMPTION: This role requires a strong understanding of clinical research principles, regulatory requirements, and the ability to interpret and present complex information.
📋 Key Responsibilities
✅ Author (write / edit) high-quality regulatory writing deliverables such as protocols, study reports, patient narratives, IBs, ICFs, CEPs / CERs, DSURs, and plain language summaries.
✅ Adhere to established regulatory standards / guidelines including ICH E3 / E6(R2), EU MDR / IVDR, Company SOPs, client standards, and approved templates.
✅ Strive to complete writing deliverables on time and within budget.
✅ Interact and communicate directly with clients, lead team meetings, and manage deliverable timelines with support from senior personnel as needed.
✅ Collaborate with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., to produce writing deliverables.
✅ Coordinate QC reviews of documents and maintain audit trails of changes as applicable.
✅ Review statistical analysis plans and table / figure / listing shells for appropriate content, grammar, format, and consistency.
✅ Assist with project-related administrative tasks with support from senior personnel as needed.
✅ Maintain familiarity with current industry practices, regulatory requirements, and guidelines related to regulatory writing.
✅ Understand budget specifications for assigned deliverables, work within the budgeted hours, and communicate out-of-scope tasks to regulatory writing leadership.
ASSUMPTION: The role may require working on complex documents under the supervision of senior personnel.
🎯 Required Qualifications
Education: Bachelor's degree in a relevant scientific field or equivalent experience
Experience: Minimum of 3 years of experience writing clinical and regulatory documents for drugs, biologics, or medical devices
Required Skills:
- Knowledge of clinical research principles
- Understanding of global regulatory bodies and applicable regulations and guidelines
- Understanding of regulatory submission requirements and processes
- Experience writing and editing scientific documents or experience in reviewing scientific data
- Experience in phase I and II and pre-clinical study experience
Preferred Skills:
- Experience in a CRO, pharmaceutical company, or biotechnology company
- Familiarity with ICH E3 / E6(R2), EU MDR / IVDR, and other regulatory standards
ASSUMPTION: Candidates with experience in writing and editing scientific documents or reviewing scientific data may be considered.
💰 Compensation & Benefits
Salary Range: €45,000 - €60,000 per year (Estimated based on industry standards for a Medical Writer with 3-5 years of experience in Ireland)
Benefits:
- Flexible working hours
- Remote work opportunities
- Professional development opportunities
- Competitive benefits package (details not specified)
Working Hours: Full-time (37.5 hours per week)
ASSUMPTION: The salary range is an estimate based on industry standards for a Medical Writer with 3-5 years of experience in Ireland. Actual salary may vary based on the candidate's qualifications and experience.
📌 Applicant Insights
🔍 Company Context
Industry: Business Consulting and Services, specifically focused on the pharmaceutical, biotechnology, and medical device industries
Company Size: 5,001-10,000 employees (Large enterprise)
Founded: 2001
Company Description:
- ProPharma helps pharmaceutical, biotechnology, and medical device companies bring life-changing therapies to market
- Offers expert guidance throughout the entire product lifecycle, from early development through clinical, regulatory approval, and commercialization
- Provides services in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology
Company Specialties:
- Compliance & Quality Assurance
- Commissioning & Qualification
- Product Lifecycle Management
- Medical Information
- Pharmacovigilance
- Computer Systems Validation
- Process Validation
- Cleaning Validation
- Technology Transfer
- CMO Selection
- Process Optimization
- Clinical Safety
- Regulatory Affairs
- PAI Readiness
Company Website: http://www.propharmagroup.com
ASSUMPTION: ProPharma is a well-established company with a strong reputation in the pharmaceutical, biotechnology, and medical device industries. They offer a comprehensive range of services to support their clients throughout the entire product lifecycle.
📊 Role Analysis
Career Level: Mid-level (3-5 years of experience)
Reporting Structure: This role reports directly to the regulatory writing leadership and works collaboratively with cross-functional teams and clients
Work Arrangement: Fully remote with flexible working hours
Growth Opportunities:
- Potential to take on more complex documents and projects as experience grows
- Opportunities for professional development and training
- Possibility of converting the contract role into a permanent position based on performance and business needs
ASSUMPTION: This role offers opportunities for growth and development within the regulatory writing team and the broader organization.
🌍 Location & Work Environment
Office Type: Fully remote (no physical office required)
Office Location(s): Dublin, Ireland
Geographic Context:
- Dublin is the capital and largest city of Ireland, known for its vibrant culture, history, and tech industry
- The city offers a high quality of life, with a mix of urban and rural environments
- Dublin has a temperate oceanic climate, with mild winters and cool summers
Work Schedule: Full-time (37.5 hours per week) with flexible working hours
ASSUMPTION: The fully remote work arrangement allows for a flexible work-life balance and the opportunity to work from various locations within Ireland.
💼 Interview & Application Insights
Typical Process:
- Online application submission
- Phone or video screening with the hiring manager
- Technical assessment or writing test
- Final interview with the regulatory writing leadership
Key Assessment Areas:
- Writing and editing skills
- Understanding of regulatory standards and guidelines
- Ability to work collaboratively with cross-functional teams and clients
- Project management and time management skills
Application Tips:
- Highlight relevant experience and skills in your resume and cover letter
- Tailor your application to demonstrate your understanding of the role and the company
- Prepare for the technical assessment or writing test by reviewing regulatory writing guidelines and practicing your writing skills
ATS Keywords: Medical Writing, Regulatory Writing, Clinical Research, Global Regulatory Requirements, Regulatory Submission Requirements, Phase I and II Studies, Pre-clinical Studies
ASSUMPTION: The application process may vary, and additional steps or assessments may be included based on the company's needs and the candidate's qualifications.
🛠️ Tools & Technologies
- Microsoft Office Suite (Word, Excel, PowerPoint)
- Regulatory writing templates and guidelines
- Project management tools (e.g., Asana, Trello, JIRA)
ASSUMPTION: The specific tools and technologies used may vary depending on the projects and the company's standards.
👔 Cultural Fit Considerations
Company Values:
- Patient-centric
- Expertise-driven
- Collaborative
- Innovative
- Committed to quality and excellence
Work Style:
- Collaborative and team-oriented
- Results-driven and focused on delivering high-quality work
- Adaptable and responsive to changing priorities and deadlines
- Strong communication and interpersonal skills
Self-Assessment Questions:
- Do you have a strong commitment to improving patient health and safety?
- Are you able to work collaboratively with cross-functional teams and clients to deliver high-quality regulatory writing deliverables?
- Do you have a results-driven and adaptable work style, with a focus on delivering high-quality work on time and within budget?
ASSUMPTION: ProPharma values a patient-centric approach, expertise, collaboration, innovation, and a commitment to quality and excellence. Candidates who align with these values and work styles will be a strong fit for the company.
⚠️ Potential Challenges
- Managing multiple projects and deadlines simultaneously
- Working with complex regulatory standards and guidelines
- Adapting to changing project priorities and requirements
- Working remotely and managing remote team dynamics
ASSUMPTION: These challenges can be overcome with strong project management skills, attention to detail, adaptability, and effective communication.
📈 Similar Roles Comparison
- This role is similar to other medical writing positions, but may have a greater focus on regulatory writing and working with complex documents
- ProPharma's global presence and expertise in the pharmaceutical, biotechnology, and medical device industries set it apart from other companies
- This role offers opportunities for growth and development within the regulatory writing team and the broader organization
ASSUMPTION: While this role shares similarities with other medical writing positions, ProPharma's unique focus and expertise in the industry make it a distinct opportunity.
📝 Sample Projects
- Writing and editing a clinical study report for a phase II study
- Creating a patient narrative for an investigational new drug (IND) application
- Reviewing and editing a data safety update report (DSUR) for a global clinical trial
ASSUMPTION: These sample projects demonstrate the range of regulatory writing deliverables that may be required in this role.
❓ Key Questions to Ask During Interview
- What are the most challenging aspects of this role, and how can I best prepare for them?
- How does this role fit into the broader regulatory writing team and the organization?
- What opportunities are there for professional development and growth within the regulatory writing team and the broader organization?
- How does ProPharma support work-life balance for its remote employees?
- What is the typical career path for someone in this role, and how can I position myself for success?
ASSUMPTION: These questions demonstrate a proactive and engaged approach to understanding the role and the company, and will help you make an informed decision about the opportunity.
📌 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 experience and skills
- Prepare for the technical assessment or writing test by reviewing regulatory writing guidelines and practicing your writing skills
- Prepare for the interview by researching the company and the role, and practicing your responses to common interview questions
- Follow up with the hiring manager after the interview to express your interest in the role and ask any remaining questions
⚠️ This job description contains AI-assisted information. Details should be verified directly with the employer before making decisions.
