Senior Medical Writer
- Galway, Republic of Ireland
- Regulatory Affairs
I am currently working with a leading medical device company located in the heart of Galway, Who have an immediate opening for a Senior Medical Writer. If you are looking to join a great team and gain great experience this is the role for you.
What I will be doing as a Senior Medical Writer?
- Responsible for supporting the development and creation of clinical, scientific and regulatory documents in accordance with procedures, European Medical Device Regulations, and US FDA requirements.
- Independently researches, prepares, writes, edits and reviews clinical evidence documents, e.g. CERs and SSCPs.
- Conducts proofreading, editing, document formatting, review comment integration and document completion/approval activities.
- Supports regulatory approval process through clinical evidence document formulation and responding to regulatory agency questions.
- Manages and maintains the procedures, systems and processes required to meet regulatory requirements for clinical evidence documents and ensures they stay up-to-date based on guidance, regulation and feedback from regulators.
- Collaborates with cross-functional teams to ensure high quality and successful project delivery.
- Develops and maintains in-depth therapeutic and product operation knowledge; applies this knowledge to the development of well written clinical evidence documents.
- Provides input to post-market surveillance and risk management activities.
- Creates and manages schedule of deliverables.
- Conducts training for medical writers, regulatory affairs and other functions, as needed.
- May supervise or mentor other medical writers, as assigned.
What I need to be a Senior Medical Writer?
- Education and/or experience equivalent to a Bachelor's Degree in the medical, biological, physical or engineering disciplines and five years of medical writing experience, preferably with CERs.
- Extensive knowledge of regulatory requirements relative to Clinical Evaluation Reports.
- Proficient in searching medical literature and databases for clinical and technical information.
- Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information and complex documents.
- Knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), EU Medical Device Regulation (2017/745) and ISO 13485 Quality System Standards.
- Effective written and verbal communication skills in the area of technical/clinical applications.
- Supervisory experience.
- Strong command of medical and surgical terminology.
- Working knowledge of statistics.
Don't miss out on a great oppurtunity to join a great team.
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales