Technical Writer İş İlanı

QUALIFICATIONS AND JOB DESCRIPTION

Qualification:

• Bachelor’s degree in any Engineering or Life Science fields;
• Excellent command of both written & spoken German & English
• Knowledge of Medical Device & Quality Management System regulations is an asset
• Good planning and problem solving skills
• Strong communication skills, both written and oral.
• Comfortable working in a regulated industry that demands tracking changes to regulatory requirements.
• Excellent interpersonal and conflict resolution skills
• Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner
• Careful attention to detail and accuracy
• Strong Microsoft Office skills and a high attention to detail.
• No obstacles with traveling
• Experience of writing in a medical, pharmaceutical, medical device, clinical research, medical or research industry or combination of these skills is preferred

Job Description:

• Reviews IFUs (Instruction for Use), 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.
• Provides medical writing, editorial and peer-review support for publications, abstracts, posters, white papers and other promotional material.
• Authors and contributes to necessary documents for regulatory submissions and communications, risk reviews and other processes such as regulatory inquiries.

· Monitor and review literature, including performing systematic literature searches. Maintain current in-depth knowledge of the clinical landscape, developments, and trends to support identified product lines and therapeutic area.

• Writes, edits, reviews, and formats documents that conform to domestic and/or international regulatory submissions (Clinical Evaluation Reports, Technical Files, Design Dossiers, Instructions for Use, Labeling, etc.) and internal document standards, while meeting project timelines.
• Coordinates content development with multi-discipline subject matter experts, both internal and external.
• Responsible for ensuring that assigned documents undergo a quality check before approval, and that documents are routed correctly in the document Quality Control process.
• Attends meetings about document(s) in development and provides management, team and reviewers with document status reports as needed.
• Supports communication strategy development.
• Collaborates with other writers to ensure continuous improvements in writing style, harmonization of terminology, and team initiatives.