Medical Writer

2 weeks ago

Cork, Cork, Ireland Tata Consultancy Services Full time

Role: Medical Writer

Job Type: Fixed Term Contract - 12 Months

Location: Cork/Dublin: Hybrid (1 - 2 days onsite at Customer Site in Cork per month, with occasional travel to Dublin, as per business needs).

Can you create high-quality, scientifically accurate, and compliant content to meet client briefs?

Join TCS as a Medical Writer and take your career to the next level

This is an exciting opportunity to contribute to the development of cutting-edge therapies and make a meaningful impact on patients' lives. You will work in a dynamic, collaborative environment with a team of passionate professionals dedicated to advancing clinical research. If you are a seasoned medical writing expert with a strong regulatory background and a commitment to quality, we would love to hear from you

The Role

As a Medical Writer 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. For this role you should have extensive and proven experience in 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). As part of this role occasional travel to the TCS Office in Dublin will be required as per business needs.

Key Responsibilities:

Document Development and Writing:

  • Author, review, and finalise high-quality clinical trial documents, including but not limited to:
  • Study Protocols and Protocol Amendments: Develop comprehensive and scientifically rigorous protocols that align with regulatory and ethical standards.
  • Initial Investigator's Brochures (IB) and IB Updates: Create and update IBs to ensure they reflect the most current clinical and non-clinical data.
  • Clinical Study Reports (CSRs): Prepare detailed and accurate CSRs that summarize study results and support regulatory submissions.
  • Develop and edit manuscripts for publication in peer-reviewed journals, ensuring they meet journal-specific guidelines and uphold the highest standards of scientific integrity.
  • Ensure all documents are written in clear, concise, and grammatically correct English, adhering to regulatory and company-specific guidelines.

Regulatory Compliance and Quality Assurance:

  • Ensure all documents comply with ICH GCP, regulatory requirements, and internal SOPs.
  • Conduct thorough quality checks to ensure accuracy, consistency, and completeness of data and content.
  • Review and interpret clinical data to ensure accuracy and consistency in documentation, aligning with study objectives and regulatory expectations.
  • Collaborate with cross-functional teams (e.g., clinical operations, biostatistics, regulatory affairs) to incorporate feedback and ensure alignment with study objectives and regulatory expectations.
  • Maintain audit-ready documentation, including version control, review comments, and approval signatures.

Scientific and Literature Support:

  • Conduct thorough literature reviews to support clinical research projects, ensuring that all documents are grounded in the latest scientific evidence and industry best practices.
  • Synthesize complex scientific and clinical data into clear, concise, and compelling narratives for regulatory submissions, publications, and internal communications.

Project Management and Coordination:

  • Plan and manage timelines for document development, ensuring timely delivery of high-quality deliverables.
  • Coordinate with internal and external stakeholders (e.g., investigators, regulatory agencies, CROs) to gather necessary input and resolve queries.
  • Demonstrate strong time management skills to handle multiple projects simultaneously and meet tight deadlines.

Collaboration and Communication:

  • Work effectively across cultures and time zones, fostering collaboration with global teams.
  • Provide expert guidance to team members on medical writing best practices, regulatory requirements, and document standardization.
  • Present complex scientific and clinical data in a clear and concise manner to diverse audiences, including non-scientific stakeholders.

Document Management:

  • Ensure final documents and supporting quality check documentation are archived in the appropriate document management system.
  • Maintain organised records of all drafts, revisions, and approvals for future reference and audits.

Your Profile

Key Experience and skills:

  • Bachelor's degree in Life Sciences, Pharmacy, Medicine, or a related field.
  • Strong experience in medical writing within the clinical research industry, with a focus on Phase 1 and Phase 2 clinical trials.
  • Deep understanding of clinical research methodologies and regulatory requirements [In-depth knowledge of ICH GCP guidelines, and compliance standards (e.g., FDA, EMA)]
  • Proven track record of authoring and managing regulatory documents such as study protocols, IBs, and CSRs.
  • Exceptional writing skills: Demonstrated ability to write clear, concise, and scientifically accurate documents.
  • Strong project management skills: Ability to plan, prioritise, and deliver high-quality work under tight deadlines.
  • Attention to detail: Meticulous approach to ensuring accuracy and consistency in all deliverables.
  • Technical proficiency: High-level expertise in Microsoft Word, Excel, and other tools for creating tables, graphs, and figures.
  • Cross-cultural collaboration: Ability to work effectively with global teams across different time zones.

Good to have:

  • Experience with electronic submission tools (e.g., eCTD).
  • Knowledge of Good Clinical Practice (GCP) guidelines.
  • Familiarity with medical terminology and clinical trial processes.
  • An advanced degree (e.g., Master's, PhD) is advantageous.

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.

Next Steps

Due to a high volume of applications, we will be unable to contact each applicant individually on the status of their application. 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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