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Role: Medical Writer
Job Type: Fixed-Term contract (12 months)
Location: Dublin, Cork
Ready to utilise your expertise in medical writing? Make a meaningful impact as a Medical Writer.
The Role:
As a Medical Writer, you will be working on medical writing within the clinical research/pharmaceutical industry, with a strong focus on Phase 1 and Phase 2 clinical trials. This role requires a deep understanding of ICH GCP guidelines, regulatory requirements, and compliance standards set by relevant agencies (e.g., FDA, EMA). In this role you will play a critical role in developing high-quality, scientifically accurate, and regulatory-compliant clinical trial documents that support the development of innovative therapies.
Key Responsibilities:
1. Document Development and Writing
o Author, review, and finalize high-quality clinical trial documents, including but not limited to:
o Study Protocols and Protocol Amendments
o Initial Investigator’s Brochures (IB) and IB Updates
o Clinical Study Reports (CSRs)
o Develop and edit manuscripts for publication in peer-reviewed journals
o Ensure all documents are written in clear, concise, and grammatically correct English.
2. Regulatory Compliance and Quality Assurance:
o Ensure all documents comply with ICH GCP, regulatory requirements, and internal SOPs.
o Conduct thorough quality checks to ensure accuracy, consistency, and completeness of data and content.
o Review and interpret clinical data.
o Collaborate with cross-functional teams.
o Maintain audit-ready documentation.
3. Scientific and Literature Support:
o Conduct thorough literature reviews to support clinical research projects.
o Synthesize complex scientific and clinical data into clear narratives.
4. Project Management and Coordination:
o Plan and manage timelines for document development.
o Coordinate with internal and external stakeholders.
o Demonstrate strong time management skills.
5. Collaboration and Communication:
o Work effectively across cultures and time zones.
o Provide expert guidance to team members.
o Present complex scientific and clinical data clearly.
6. Document Management:
o Ensure final documents are archived in the appropriate document management system.
o Maintain organized records of all drafts, revisions, and approvals.
Key skills/knowledge/experience:
* Professional experience in medical writing within the clinical research industry.
* Strong understanding of clinical research methodologies and regulatory requirements.
* Ability to work independently and as part of a team.
* Proven track record of authoring and managing regulatory documents.
Rewards & Benefits
TCS is consistently voted a Top Employer in the UK and globally. Our competitive salary packages feature pension, health care, life assurance, laptop, phone, access to extensive training resources and discounts within the larger Tata network.
Diversity, Inclusion and Wellbeing
Tata Consultancy Services UK&I is committed to meeting the accessibility needs of all individuals. We believe in building and sustaining a culture of equity and belonging where everyone can thrive.
If you are an applicant who needs any adjustments to the application process or interview, please contact us at UKI.recruitment@tcs.com with the subject line: “Adjustment Request” or call TCS London Office 02031552100.
Next Steps
Due to a high volume of applications, we will be unable to contact each applicant individually. If you have not received a direct response within 30 days, then it should be deemed unsuccessful on this occasion.
Join us and do more of what matters. Apply online now.
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