Medical Writer

Cerner Enviza (an Oracle company) is a leading global healthcare consulting firm and trusted advisor to many of the world’s top pharmaceutical, biotech, and medical device & diagnostic companies. By supporting the work of Cerner Enviza, you will work with world-class healthcare companies, helping them improve global access to medicines by connecting science and research.

With ongoing and ground-breaking developments in Oncology and Rare Disease, an increased focus on more scientific, targeted medicine and continuous integration of technology into development and delivery of medicine, there has never been a more exciting time to work in Life Sciences and, with Cerner Enviza immersed in all of these, there has never been a better time to join us and make a difference to our clients and the lives of patients.

Cerner Enviza are seeking a Medical Writer I who will be responsible for the creation of documents, point of contact for clients, assisting in writing simple proposals and methodology sections of more complex proposals with input from senior team members.

**Diversity and Inclusion:
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In order to nurture the talent that makes this happen, we are committed to an inclusive culture that celebrates and values diverse insights and perspectives, a workforce that inspires thought leadership and innovation..

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The Medical Writer I is responsible for the creation of documents in both English or German, the writing of study reports for non-interventional and clinical studies, preparation of manuscripts, posters and abstracts and the preparation of other project-specific documents such as observational plans and study protocols.

The Medical Writer I will be responsible for the creation of components of submission dossiers (modules of the Common Technical Document [CTD]) and safety reports (Periodic Benefit-Risk Evaluation Reports [PBRER] / Periodic Safety Update Reports [PSUR], Post Market Surveillance Reports [PMSRs] and Development Safety Update Reports [DSUR]).

They will providing advice to Sponsors on the most appropriate presentation of data in the light of regulatory agency requirements as well as on interpreting and describing data Supports Drug Safety Officer in creation of narrative safety reports and corresponding inquiries.

The Medical Writer I will develop relationships with clients and is considered a junior point of contact by clients for project requests / questions. They will assists in writing simple proposals and methodology sections of more complex proposals with input from senior team members and prioritises workload without major input from Team Leader Medical Writing to ensure agreed deadlines are met.

The Medical Writer will develops their own knowledge and personal skills in line with business requirements and keep abreast of developments in the pharmaceutical industry. The Medical Writer will execute job responsibilities as directed throughout the transition period to ensure continuous client service and business operations. They will attend and actively participate in transition related meetings and informational sessions and contribute to team knowledge base and information sharing.

The Medical Writer I is responsible for the creation of documents in both English or German, the writing of study reports for non-interventional and clinical studies, preparation of manuscripts, posters and abstracts and the preparation of other project-specific documents such as observational plans and study protocols.

The Medical Writer I will be responsible for the creation of components of submissi