Medical Writer (CER)

Medical Writer (CER)
Role & Responsibilities:
Writing and reviewing of clinical and regulatory documents related to Drugs, medical devices or in-vitro medical device
Writing and reviewing clinical/regulatory documents such as clinical trial protocols, Clinical evaluation Plans, Clinical evaluation reports, investigator brochures, informed consent forms, according to ICH or other guidelines.
Responsible for preparation of documents that support the presentation and/or publication needs of assigned therapeutic areas and/or medical devices in the clients Strategic Medical Affairs Team for a wide range of audiences.
Responsible for compliant writing of Clinical Evaluation Reports, clinical study report or performance evaluation report within the business in accordance to local procedures, the clients guidelines and regulatory requirements
To participate in post-market surveillance activities by conducting routine systematic literature reviews (e.g. Screening of articles against inclusion/exclusion criteria, extract data from included studies, interpreting study results and to prepare summaries into formal reports) for specific medical device groups or sub groups.
Publication manuscripts, abstracts, posters (content writing) and presentations
Interpreting study results and preparing summaries into formal reports) for specific medical device groups or subgroups.
Develop templates for reports and other regulatory documents.
Responsible for preparing the Clinical Overview (2.5 Module) and Non-Clinical Overview (2.4 Module) documents.
Qualification:
Any Bachelor / Master in Life Sciences Only
Required: 4-6 years of experience in Medical Writing (CER or Medical Devices or IVD/IVDR) or a related field.