Principal Medical Writer – Germany

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

📋 Description

• Conducts research, authors, and edits clinical study reports and study protocols, while summarizing data from clinical trials.

• May act as the primary author, contributing to complex clinical, scientific, and program-level documents, including Investigational Brochures (IBs), Investigational New Drugs (INDs), and Marketing Authorization Applications (MAAs).

• Offers senior-level review for both routine and complex documents.

• Provides training and guidance to other writers and program managers on document preparation, software tools for document development, document types, regulatory standards, and knowledge of therapeutic areas.

• Ensures adherence to quality processes and requirements for assigned documents.

• As the subject matter expert, establishes and reviews best practices, methods, and techniques for achieving optimal results, including various client-specific processes, and spearheads process improvement initiatives.

• May also create, review, and oversee performance metrics for assigned projects.

• Represents the department during project launch meetings, review sessions, and project team gatherings.

⛳️ Requirements

• Bachelor's degree in a scientific field or equivalent academic/vocational qualification.

• Advanced degree is preferred.

• Prior experience that equips the candidate with the knowledge, skills, and abilities necessary for the role (approximately 8+ years).

• Required experience in managing and directing complex medical writing projects.

• Preferred experience in the pharmaceutical/CRO industry.

• Experience with submissions documents is advantageous.

• Background in Neurosciences is beneficial.

• Additional qualifications in medical writing (AMWA; EMWA; RAC) are advantageous.

• Comprehensive knowledge of global, regional, national, and other document development guidelines.

• In-depth expertise in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.

• Exceptional data interpretation and medical writing abilities, including grammatical, editorial, and proofreading skills.

• Strong project management competencies.

• Advanced interpersonal, oral, and written communication skills, along with effective presentation abilities.

• Excellent negotiation capabilities.

• Sound judgment; a high level of independence in decision-making and problem-solving.

• Capability to mentor and lead junior staff members.

🏝️ Benefits

• Competitive salary.

• Flexible working culture.

• Award-winning learning and development program.

• Comprehensive benefits package.

• Health and well-being programs.