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Senior Medical Writer

Location: Galway, Republic of Ireland Salary:
Sector: Regulatory Affairs (RA) Type: Permanent

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, analyse, 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 opportunity to join a great company!!!

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