Senior Medical Writer
WHO WE ARE
Our goal is to advance and accelerate how medical devices are developed by analysing and interpreting clinical data in a way that it is easily understandable, exploits the full potential of the data and advances healthcare globally.
ECLEVAR is an equal opportunity employer
As part of our growth and expansion throughout Europe and the United States, we are looking for a talented and driven Medical Writer to support our medical writer team:
- Writes and contributes to Clinical Evaluation reporting deliverables including Clinical Evaluation Plans/Reports, PMS and PMCF Plans/Reports, SSCPs, Regulatory Responses and other related documentation.
- Evaluates and summarizes clinical evidence including data from sources such as clinical investigations, literature, post-market surveillance, risk, and post market clinical evaluations. Analyzes results in preparation for product applications and submissions.
- Collaborates with team members and stakeholders in planning for and supporting CER related projects and processes.
- Supports additional clinical, regulatory, quality and engineering related deliverable as assigned.
- Effectively communicates and collaborates with Sales and Marketing, R&D, Regulatory Affairs, Library Services, Product Performance Group (PPG), Quality Engineering, Clinical Affairs, Clinical Science, Risk Management and Medical Affairs in completing clinical evaluation project related deliverables.
- Maintains thorough knowledge of assigned products. Identifies appropriate sources of relevant data, interprets, evaluates and incorporates information from various sources including literature, clinical data, and medical references.
- Reviews IFUs, patient guides, Risk Management files, Clinical Evaluation Protocols, Clinical Evaluation Reports and Plans (CER/CEP), physician training materials, ensuring alignment of risk information. Involved in responses to complex queries such as those issued by notified bodies and stakeholders.
- Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews and other processes such as regulatory inquiries.
- Ensures quality in all deliverables and documentation with attention to detail, consistency and integrity of data. Responsible for compliance with applicable corporate and divisional policies and procedures. Ensures compliance to applicable regulations and guidance’s (ISO13485, ISO14155, ISO14791, MEDDEV 2.7.1, MDR, and EU and FDA guidance documents) and applicable Abbott SOPs and DOPs
WHO YOU ARE
- Degree (B.S. or M.S.) in biology, chemistry, natural sciences, molecular biology, genetics
- Experience in scientific writing, including writing for both technical and non-technical audiences
- Must have exceptional attention to detail
- Must have more than 3 years experience in medical writing of CER
- Self-motivated, creative and works independently
- You take pride in your work and hold everything you do to high standards
- Adaptive and strong organisation skills
BENEFITS OF WORKING AT ECLEVAR
- Competitive salary : 50-80K euro /year
Working at ECLEVAR means working at the forefront of innovation. Our cutting-edge technologies and medical device solutions are developed at the highest standard and safety for the patients.
Start date: ASAP
Home based/Office based