Medical Writer
Dr. Notghi CRO is a contract research organization (CRO) providing statistical, data management, clinical study monitoring and medical writing services to pharmaceutical, biotechnology, and medical devices companies. As we continue to expand our business, we are currently seeking a highly qualified and motivated individual to work at our office in Berlin as a Medical Writer.
Job Summary
The Medical Writer will research, create, edit, and coordinate the production of clinical documents associated with regulatory submissions. The Medical Writer will also be responsible for the production of clinical study documentation associated with clinical trials that may not be included in a regulatory submission.
Key Responsibilities
- Participates in strategic planning and project meetings with internal and client teams as needed
- Develops, writes and edits materials as assigned and may work under close supervision of Medical Directors on specific initiatives
- Conducts research on assigned topics and secures references; performs fact checking function and completes annotations in electronic files, ensuring that information is presented accurately
- Performs thorough editorial review of material and collaborates to resolve errors or concerns
- Properly tracks and retains electronic versions of documentation from draft through final submission to clients.
- Maintains a current knowledge of industry trends and standards and key medical topics and terminology in order to serve as a creditable resource to internal and client teams
- Understand relationships and dependencies between documents and analyses produced for regulators including the development RMP, DSUR, PBRER, and ACO
- Collaborate with quality lines and relevant project team subject matter experts, ensuring the accuracy and quality of information presented in assigned documents
- Identify potential areas for process improvements and possible solutions, and communicate these to line management or appropriate functional line
- May be assigned copywriting responsibilities for business activities such as website articles, pitch materials and self-branding
Qualifications and Experience
- Degree or qualification in life sciences (master’s or Ph.D. in a scientific or medical discipline with 1 or more years medical writing experience; Bachelor’s degree in a scientific or medical discipline with 3-5 years medical writing experience may be acceptable)
- Pharmaceutical industry experience, ideally in safety, regulatory or clinical areas
- Familiarity with epidemiologic principles and concepts is desirable
- Proficiency with statistical concepts and ability to carry out statistical analyses is desirable
- In-depth knowledge of medical terminology.
- Proficiency in Microsoft Office suite, including Outlook, Word, Excel and PowerPoint
- Knowledge of ICH/GCP, AMG and relevant rules and guidelines
- Excellent oral and written English and German knowledge
Personal skills & Attributes
- High level of attention to detail to ensure accuracy with medical content, including referencing
- Proven time management skills, including successful track record of meeting deadlines while managing multiple projects simultaneously
- Excellent oral communication skills with clients as well as strong listening and analytical skills
- Excellent attendance record and schedule flexibility to meet client deadlines
- Strong team player
Please send your application to: jobs@notghi.com or use our online application form.