Senior Medical Writer, Safety Support Services

MSD; Puerto Bogotá; Presencial; COP 120.000.000 - 180.000.000; Jornada completa

Descripción de la vacante

MSD in Colombia is seeking a Senior Medical Writer to develop, edit and lead reviews of clinical, regulatory, and public-facing documents across multiple programs. You will work with a project lead to ensure accuracy, clarity and regulatory compliance while applying health literacy principles.

The role requires a Bachelor’s degree in health or science and at least 3 years of medical writing experience, with strong writing, communication and collaboration skills.

Formación

• Experience managing multiple writing projects in a deadline-driven environment and leading teams of writers.
• Ability to interpret clinical data clearly and in line with regulatory requirements 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 workload demands to help the team succeed.
• Strong oral and written communication and presentation skills.
• Proficiency with Office applications and SharePoint; willingness to learn emerging technologies.

Responsabilidades

• Develop, author, edit and lead review of clinical, regulatory and public-facing documents.
• Collaborate with cross-functional teams and project leads across programs and therapeutic areas.
• Ensure documents meet regulatory requirements and health literacy standards.

Conocimientos

Medical writing

Project leadership

Data interpretation

Critical thinking

Conflict resolution

Cross-functional collaboration

Oral and written communication

Educación

Bachelor’s degree in health/science

Herramientas

Microsoft Office Suite

SharePoint

Descripción del empleo

Job Description 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.

Additional location(s) Compensation Information: Required Skills

• Adaptability
• Adaptability
• Business Software Applications
• Clinical Data
• Clinical Operations
• Clinical Study Design
• 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

Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where we have codified our legacy for over a century. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.