We have a fantastic opportunity for a CER Writer to join our Medical Device Client working across their extensive portfolio of products. The business is passionately committed to partnering with medical professionals to help elevate the delivery of patient care and improve clinical outcomes, and this role will suit someone who is experienced in CER's, CEP's and PMCF's. Hybrid/remote working is also on offer!
- Conduct scientific literature reviews and compile reports, such as annual literature updates and periodic safety updates, to provide to global regulatory agencies
- Generate protocols and reports using a well-defined scientific/research methodology
- Write and contribute to Clinical Evaluation Plans, Clinical Evaluation Reports, Post Market Clinical Follow-Up Plans and Reports, and Summaries of Safety and Clinical Performance supporting multiple products
- Write Post Market Surveillance Plans and reports
- Provide clinical input for updating the Instructions For Use (IFU) and Risk Assessments
- Collaborate with team on responses to questions / requests for more information from reviewers and auditors regarding these documents
- Conduct ad hoc literature reviews and data synthesis as required to address the questions referenced above
- Create and maintain standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
Skills and experience
- Scientific background (BS or above in Biology, Chemistry, Biomedical Engineering, or related field)
- Experience conducting systematic literature reviews for medical devices required (experience with medical databases such as Pubmed preferred)
- Experience writing or contributing to Clinical Evaluation Reports compliant with MEDDEV 2.7/1 rev 4 required
- Experience with MDD essential. MDR experience preferred
- Knowledge of ISO 10993-1 and 10993 series of standards preferred but not essential
- Must have excellent written and verbal communication skills
- Must have an ability to work to deadlines, be self-motivated and well organised
- Experience writing or contributing to Clinical Evaluation Reports compliant with EU MDR 2017/745 desired
- Ability to understand and interpret results of clinical studies, with a strong understanding of statistics
- Expertise in conducting focused literature searches on PubMed, MedLine or other similar literature databases
- Effective written and oral communication skills
- Ability to formulate reports and present findings
- Ability to prioritize and manage multiple projects
- Strong familiarity with Microsoft Office
- Data-mining and analysis skills.
For immediate consideration please forward your most up to date CV
Austin Fraser is acting as an Employment Agency in relation to this vacancy.
Austin Fraser is committed to being an equal opportunities employer, and encourages applications from candidates regardless of sex, race, disability, age, sexual orientation, gender reassignment, religion or belief, marital status, or pregnancy and maternity status.
Due to the volume of applications received, we are unable to provide individual feedback to unsuccessful applicants.