Medical Writer (m/f/d)

Responsible for conducting applied research in scientific area of focus. Investigating applicable solutions through rigorous, protracted studies and ensuring that a quality, integrated solution is delivered in a timely manner, at budget, and to our client*s satisfaction.

This involves working closely with the client to understand and manage their expectations, as well as working closely with Oracle and third-party vendors to ensure delivery.

intermediate-level position who is responsible for applying scientific, clinical, and healthcare knowledge to provide solutions to customers.

Apply best-in class research theories and methods to deliver an optimal solution build and implementation. As a member of team, exercises judgement within defined procedures to introduce innovative research collection and analysis methodologies on external customer engagements.

Work involves using analytical skills sufficient to interpret data / instructions and applying the relevant research techniques with some autonomy.

Receives general instruction on new projects or assignments. Makes recommendations to enhance performance and research results.

Possesses solid knowledge in reference to creating project and client related research materials.Bachelors or Advanced degree in a discipline relevant to area of focus, plus 2 year related work experience.

Minimum Qualifications : At least 5 years Total combined related work experience and completed higher education. Depending on the job there may be additional minimum requirements and / or preferred qualificationsAs part of Oracle's employment process candidates will be required to successfully complete a pre-employment screening process.

This will involve identity and employment verification, professional references, education verification and professional qualifications and memberships (if applicable).

Oracle Life Sciences is a leader in cloud technology, pharmaceutical research, and consulting, trusted globally by professionals in both large and emerging companies engaged in clinical research and pharmacovigilance, throughout the therapeutic development lifecycle, including pre- and post-drug launch activities.

With more than 20 years’ experience, Oracle Life Sciences is committed to supporting clinical development and leveraging real-world evidence to deliver innovation and accelerate advancements empowering the Life Sciences industry to help improve patient outcomes.

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.

RESPONSIBILITIES : The creation of documents in both English or GermanWriting of study reports for non-interventional and clinical studiesPreparation of manuscripts, posters and abstractsPreparation of other project-specific documents such as observational plans and study protocolsCreation 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 )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 dataSupports Drug Safety Officer in creation of narrative safety reports and corresponding inquiriesDevelops relationships with clients and is considered a junior point of contact by clients for project requests / questionsAssists in writing simple proposals and methodology sections of more complex proposals with input from senior team membersPrioritises workload without major input from Team Leader Medical Writing to ensure agreed deadlines are metDevelops own knowledge and personal skills in line with business requirementsKeeps abreast of developments in the pharmaceutical industryExecute job responsibilities as directed throughout the transition period to ensure continuous client service and business operationsAttend and actively participate in transition related meetings and informational sessionsContribute to team knowledge base and information sharingExpand network to broaden working relationships with Cerner colleaguesQUALIFICATIONS : Master's degree in life sciences subjectMedical writing experience within a CRO, life science, pharmaceutical or medical organizationAbility to work within timeframes and deliverAbility to manager several projects at onceADDITIONAL INFORMATION : All employees must be legally authorized to work in the country where the position is located.

Work visa sponsorship is not available for this position. At Oracle, we don’t just respect differences we celebrate them.

We believe that innovation starts with inclusion and to create the future we need people with diverse backgrounds, perspectives, and abilities.

That’s why we’re committed to creating a workplace where all kinds of people can do their best work. It’s when everyone’s voice is heard and valued that we’re inspired to go beyond what’s been done before.

We expressly encourage disabled candidates to apply for this position. Please therefore feel free to voluntarily inform us in your application about any severe disability (degree of disability of at least 50%) or any equal status (degree of disability of at least 30% together with official decision on equality) in accordance with the German SGB IX. Posting Date : 2024-03-04