Senior Medical Writer, Safety Support Services

MSD; Guaduas; Hybrid; COP 90,000,000 - 120,000,000; Full time

Benefits offered by this job

Hybrid work

Job summary

MSD Colombia, part of the Clinical and Regulatory Strategic Communications (CRSC) within GCTO, seeks a Senior Medical Writer to independently prepare regulatory and public-facing documents and to lead cross-functional teams.

You will apply health literacy principles, manage timelines, mentor junior writers, and help advance medical writing processes while ensuring compliance with regulations.

Qualifications

• Bachelor’s degree in health, scientific, or relevant discipline.
• 3 years of relevant medical writing or industry experience.
• Experience managing multiple writing projects and leading teams.

Responsibilities

• Prepare clinical/regulatory and public-facing documents with minimal supervision.
• Lead cross-functional teams and contribute to project leadership.
• Interpret clinical data clearly in line with regulatory requirements.
• Demonstrate critical thinking and problem-solving across MW scope.
• Mentor junior writers and support process improvements.

Skills

Project leadership

Regulatory knowledge

Critical thinking

Communication skills

Problem solving

Conflict resolution

Adaptability

SharePoint proficiency

MS Office proficiency

Education

Bachelor’s degree in health sciences or related discipline

Tools

Microsoft Office Suite

SharePoint

Job description

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:

• 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 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 {+ 6 more}

Employee Status:

Regular

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Hybrid

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

10/30/2026

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