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Job ID: JOB-13639

Senior Medical Writer  (Hybrid)

Our Client is Enniscorthy is seeking a Senior Medical writer to join their team on a permanent basis.

This individual will be supporting the Global Peripheral Intervention Business Unit within the Medical Affairs function and reporting to the Program Manager, Medical Writing. The Senior Medical writer will prepare clinical documentation for regulatory submissions while working within a cross-functional team.

Key responsibilities

• Support of new product development activities (e.g. development of clinical strategies) applying problem-solving skills and decision making with cross-functional project team;
• Writing and maintaining of documents required for EU MDR submissions, such as Clinical Evaluation Plans and Reports, Post-market Clinical Follow Plans and Reports in compliance with applicable regulatory requirements (e.g. EU MDR, MEDDEV 2.7/1, MDCG);
• Writing and compilation of documents for regulatory submission during all phases of clinical development and the post-market period, such as EC Submissions, Clinical Study Protocols, Clinical Study Reports, Investigator’s Brochures, Periodic Benefit-Risk Evaluation Reports, safety plans and reports;
• Provide comprehensive responses to clinical questions raised by regulatory body reviews (e.g. Notified Body, FDA, etc.) and support international product registrations and regulatory audits;
• Project management and organization of external service providers (e.g. CROs);
• Support international clinical studies as needed (up to 10% potential to travel)

Key Qualifications:

• The ideal candidate will have previous experience in clinical evaluations working in cross-functional teams in the Medical Device/Pharmaceutical industry, or in a similar setting related to medicine or Life Sciences (2-4 years of experience medical writing or 3-5 years of relevant work experience).
• You will have a clear, concise scientific style of writing. As a result of this experience, the candidate will be able to successfully:
• Strong ability to research and write a wide range of quality documents with minimal supervision.
• Review each of these document types and provide input for improvement.
• Conduct and document systematic scientific literature searches and data analyses, interpret & summarise the data.
• Collaborate and complete complex deliverables within a cross-functional team across departments.
• The ideal candidate will hold an academic degree in a relevant field (Master of Science or higher graduate degree). Ideally you will have proficiency in literature database searches, basic knowledge of biostatistics and medical background/application of products.

For further information on this role in please contact Mark Wilson on 0860449473 or email talent@hero.ie

Check out all our open jobs on our HERO Recruitment website – https://www.hero.ie/

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Data can only be transferred outside of the EEA on the basis of standards contractual clauses, to a country for whom an adequacy decision has been given by the European Commission or where the express permission of the data subject has been given. You have supplied us with your personal data in the process of applying for a position. Our client company may have personnel outside of the EEA who will review you data. We will apply the appropriate criteria in respect of the data transfer depending on the location of those personnel.

Mark Wilson

JOB-13639

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