Matrix Recruitment are seeking to recruit a Medical Writer/Clinical Affairs Specialist for our multinational client, based in the Wexford area.
This is a new and exciting position with a very successful company where you will be responsible for executing and leading clinical studies. International travel is a part of this role (up to 10%).
Remote working is an option for this role, but some onsite work as required.
This is a permanent job.
Key duties & responsibilities:
- Responsible for the execution of clinical studies
- Work closely with internal and external (CRO’s) teams for national and international clinical studies
- Support NPD team by applying problem-solving skills for any issues with cross functional team
- Writing and maintaining Clinical Evaluation plans, post market Clinical Follow Plans and reports in compliance with regulatory requirements
- Responsible for writing study protocols, reports, and safety plans along with all documents for regulatory submission during each phase of the study and post marketing period (EC Submissions, Periodic Benefit- Risk Evaluation reports, investigator’s brochure)
- Support international product registrations and regulatory audits
- Conduct scientific literature searches and data analyses
What are we looking for?
- Degree in Science/Regulatory Affairs/Quality/Related Field
- Minimum 3 years’ experience in similar role
- Experience working in pharmaceutical/medical device or life science industry
- Scientific Style of writing
- Proficient with literature database searches and knowledge on biostatistics
Apply for this job now by emailing your WORD formatted CV to Roisin on email@example.com or call 087 4056704.
Please note that due to the expected high volume of applications we can only reply to applicants suitable for the position. In the interest of protecting your data and informing you of your rights we will notify you should we retain your information by issuing an acknowledgement email and a request for consent where not already expressly given.
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