This is a fully remote position, open to applicants in Germany.

📋 Description

• Oversees staff and facilitates the professional growth of direct reports by establishing objectives, conducting performance evaluations, assessing training requirements, formulating development plans, and providing mentorship and coaching.

• Prioritizes tasks, allocates department resources, implements corporate objectives, and devises alternative solutions to meet business and operational goals.

• Collaborates with and advises team members on administrative policies and procedures, technical challenges, priorities, and methodologies.

• Manages and supervises the team's medical writing outputs in accordance with company or client standard operating procedures.

• Evaluates medical writing deliverables for completeness, accuracy, and overall quality, and assumes accountability for the quality of departmental outputs.

• Assists the company’s medical writing leadership team in strategizing, developing, and implementing document development plans, presenting quarterly business updates, and resolving issues.

⛳️ Requirements

• A Bachelor’s degree is required, along with relevant scientific and/or medical knowledge and expertise.

• A minimum of 6 years of progressive experience in medical writing is required; management or supervisory experience of at least 1 year is preferred.

• Proficient knowledge of English grammar; familiarity with FDA, EU, ICH, and ISO regulations and guidelines related to drug/device and document development; and medical writing processes, systems, procedures, and best practices.

• Understanding of clinical research principles.

• Strong management and independent working abilities; excellent written composition and editorial skills; and capabilities in program planning and execution.

• Proficient in Microsoft Office Suite.