Senior Medical Writer

Jobtailor; Deutschland; Remote; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Jobtailor is seeking a senior Medical Writer Lead to drive the completion of diverse medical writing deliverables in Germany. You will manage study documents across departments with minimal supervision and ensure adherence to regulatory standards and templates.

You will coordinate quality reviews, respond to client comments, and mentor junior writers while collaborating with regulatory, data management, biostatistics, and medical affairs teams.

Qualifikationen

• Extensive experience in medical writing and drug development.
• Ability to lead deliverables with minimal supervision.
• Knowledge of regulatory standards and templates.
• Experience coordinating quality and editorial reviews.
• Ability to mentor junior writers.

Aufgaben

• Lead clear and accurate medical writing deliverables.
• Manage medical writing activities across studies with minimal supervision.
• Lead resolution of client comments.
• Collaborate with cross-functional teams including regulatory, data management, and medical affairs.
• Mentor and lead less experienced medical writers.

Kenntnisse

Medical writing

Leadership

Regulatory knowledge

ICH E3 guidelines

Client collaboration

Jobbeschreibung

• Lead the clear and accurate completion of medical writing deliverables
• Manage medical writing activities for individual studies across departments with minimal supervision
• Lead resolution of client comments
• Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations
• Apply regulatory standards, company SOPs, client standards, approved templates, authorship requirements, and style/formatting guides
• Coordinate quality and editorial reviews
• Lead team document reviews and review documents as needed
• Act as peer reviewer for internal teams
• Review statistical analysis plans and table/figure/listing specifications
• Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams
• Perform online clinical literature searches and comply with copyright requirements
• Identify and propose solutions to issues, escalating as appropriate
• Provide technical support, training, and consultation
• Contribute to internal materials, presentations, processes, standards, and capabilities
• Mentor and lead less experienced medical writers on complex projects
• Develop expertise in industry topics and regulatory requirements
• Monitor project budgets and communicate status and changes to medical writing leadership
• Complete required administrative tasks
• Perform other assigned work-related duties

Requirements

• Experience and deep expertise in medical writing and drug development
• Ability to lead clear and accurate medical writing deliverables with minimal supervision
• Knowledge of regulatory standards, including ICH E3 guidelines
• Ability to work with company/client SOPs, standards, templates, authorship requirements, and style/formatting guides
• Experience coordinating quality and editorial reviews and managing source documentation
• Ability to peer review scientific content for clarity, consistency, and format
• Ability to review statistical analysis plans and table/figure/listing specifications
• Clinical literature search skills and knowledge of copyright requirements
• Ability to provide technical support, training, and consultation
• Ability to mentor less experienced medical writers
• Knowledge of industry topics and regulatory requirements affecting medical writing
• Ability to work within budgeted hours and complete administrative tasks on time
• Equivalent experience, skills, and/or education will also be considered
• Minimal travel may be required (less than 25%)

Core Competencies

Demonstrates expertise in medical writing and drug development, with a strong ability to lead the completion of various medical writing deliverables while adhering to regulatory standards and company guidelines. Capable of mentoring less experienced writers and providing technical support across multiple projects.

Highest-signal resume keywords

• Medical Writing Expertise
• Regulatory Standards Knowledge
• Statistical Analysis Review
• Quality and Editorial Review Coordination
• Mentoring and Training Skills

ATS Optimization Keywords

Hard Skills

• Clinical Study Protocols
• Clinical Study Reports
• IND Submissions
• NDA Submissions
• ECTD Submissions
• Statistical Analysis Plans
• Clinical Literature Searches
• Document Review
• Technical Support
• Administrative Task Management

Soft Skills

• Leadership
• Collaboration
• Problem-Solving
• Communication
• Mentoring

Industry Keywords

• ICH E3 Guidelines
• SOPs
• Authorship Requirements
• Copyright Compliance
• Clinical Development Plans
• Plain Language Summaries
• Periodic Safety Update Reports
• Investigator Brochures
• Patient Narratives
• Journal Manuscripts