Medical Technical Writer/Editor - Remote

Job Title: Medical Technical Writer/Editor

Skills:

The job involves working in global, cross-functional study and project teams, coordinating, and supervising a time-sensitive technical process with cross-functional involvement. Additional complexity is introduced by external providers and awareness of cultural diversity. The job requires handling numerous complex tasks simultaneously.

Sound knowledge of document management systems, clinical documents standards, clinical trials, their documentation, and regulatory requirements. Deep knowledge of international writing standards and conventions and regulatory writing. Sound knowledge of safety reporting and regulatory requirements. Ability to proactively identify problems and initiate improvements. Understanding of the business impact of timelines for clinical documents.

Excellent written and verbal English skills, sound knowledge of MS Office (especially Word, Adobe), Microsoft 365, document management systems, and high IT affinity. Places a high priority on regulatory compliance and quality. Ability to manage projects effectively across regions and in matrix environments, including time management and oversight of external providers. Ability to manage parallel tasks and variable workload. Strong interpersonal and social skills, ability to communicate effectively in international cross-functional teams, cultural sensitivity.

Education:

Master's degree with a minimum of 2-3 years or a bachelor's degree with a minimum of 3-5 years of working experience, preferably in e.g. natural sciences, pharmacy, medicine or digital technologies, project management or communication science or any other relevant field with at least 3 years of professional experience preferably in clinical operations or related areas; alternatively vocational training, associate's degree, technical college e.g. in medical documentation or other relevant fields, with at least 5-8 years of professional experience and preferably 3 years of experience in technical writing, clinical operations or related areas.

Skills and Experience:

Required Skills:

ADOBE ACROBAT

PROJECT MANAGEMENT

REGULATORY COMPLIANCE

DOCUMENT MANAGEMENT SYSTEMS

MICROSOFT OFFICE

Additional Skills:

EXCELLENT WRITTEN AND VERBAL COMMUNICATION SKILLS

MEDICAL WRITING

• Project management skills

• Sound knowledge of standard clinical documents, regulatory requirements

• Sound knowledge of electronic Document Management Systems (e.g. Veeva)

• Deep knowledge of MS Office (Word, Excel, Adobe), Microsoft 365

• IT affinity