Senior Medical Writer, Safety Support Services

Merck; Puerto Bogotá; Hybride; COP 48 000 000 - 72 000 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement

Résumé du poste

Merck's Clinical and Regulatory Strategic Communications (CRSC) team seeks a Senior Medical Writer to author, edit, and lead review of clinical, regulatory, and public‑facing documents across programs and therapeutic areas. You will apply health literacy principles in line with regulatory requirements and support the company portfolio.

The role emphasizes independent document preparation, collaboration on cross‑functional teams, and potential mentoring of colleagues, with a flexible hybrid work

Qualifications

• Bachelor's degree preferably in a health, scientific, or relevant discipline.
• 3 years of relevant medical writing or industry experience.
• Ability to interpret clinical data clearly per regulatory requirements.
• Experience leading teams and coordinating cross-functional projects.

Responsabilités

• Prepare, edit, and review clinical, regulatory, and public-facing documents.
• Lead cross-functional teams and mentor junior writers as needed.
• Apply health literacy principles to communicate clearly and compliantly.
• Manage multiple projects, timelines, and stakeholder expectations.
• Utilize medical writing tools and platforms effectively.
• Contribute to process improvements and knowledge sharing.

Connaissances

Adaptability

Collaboration

Critical Thinking

Medical Writing

Conflict Management

Presentation Delivery

Project Leadership

Project Management

Formation

Bachelor's degree in life sciences or health

Outils

Microsoft Office Suite

SharePoint

Description du poste

The Clinical and Regulatory Strategic Communications (CRSC) department within GCTO creates and delivers high-quality regulated content in support of our development pipeline and enables data sharing for our customers. We are a strategic partner that ensures excellence and compliance with applicable laws while incorporating health literacy principles in the development of public‑facing materials.

The Senior Medical Writer, in partnership with a project lead, develops, authors, edits and leads the review of accurate, clear, and compliant clinical, regulatory, and/or public‑facing documents, across multiple programs and therapeutic areas, in support of the company portfolio.

The Senior Medical Writer:

• Demonstrates independence in preparing clinical regulatory (e.g., protocols, clinical study reports, participant narratives, investigator's brochures) and/or public‑facing (e.g., informed consent forms, clinical trial registration and results postings, plain language summaries) documents per company and evolving regulatory requirements.
• Applies an in-depth knowledge and understanding of design, planning, authoring, editing, and review of accurate, clear, high-quality documents that reflect applicable medical writing best practices (e.g., lean writing, health literacy).
• Is a scientific contributor and collaborator on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities.
• Applies emerging critical thinking, problem solving, and negotiation skills to implement solutions to challenges across the medical writing scope of work (e.g., documents, content, processes, timelines, tools) while navigating project team dynamics. Keeps medical writing project lead and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance.
• Applies knowledge of medical writing-specific tools and technology platforms.
• Participates in or leads initiatives to improve medical writing processes and standards; may serve as a resource for this work internally and externally, as appropriate.
• Applies knowledge of clinical development, relevant regulations, disease areas, and company products.
• May help with other departmental needs, such as orientation of new team members or mentoring less experienced writers.
• May manage direct reports, including workload, professional development, and performance management.

Qualifications

• Required: Bachelor's degree preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health)
• 3 years of relevant medical writing or industry experience.

Required skills & experience

• Experience managing multiple writing projects in a deadline-driven environment and leading teams of medical writers and/or cross-functional team members.
• Ability to interpret clinical data clearly, objectively, and in accordance with regulatory requirements and industry guidelines, with minimal supervision.
• Demonstrated critical thinking and problem-solving capabilities.
• Experience with conflict resolution and negotiation in cross-functional teams.
• Ability to adapt to changing project needs and unexpected workload demands to help team succeed.
• Strong oral and written communication and presentation skills.
• Technical expertise in commonly used office applications (e.g., Microsoft Office Suite) and shared document systems (e.g., SharePoint) and willingness to learn and adapt to emerging technology.

Required Skills

• Adaptability
• Adaptability
• Business Software Applications
• Clinical Data
• Clinical Operations
• Clinical Trial Compliance
• Clinical Trial Management
• Collaboration
• Competency Management
• Conflict Management
• Critical Thinking
• Data Analysis
• Ethical Standards
• File Sharing
• ICH GCP Guidelines
• Knowledge Sharing
• Lateral Thinking
• Legal Compliance
• Logical Thinking
• Medical Writing
• Motivation Management
• Presentation Delivery
• Project Leadership
• Project Management Leadership {+ 6 more}

Flexible Work Arrangements: Hybrid

Haz