Senior Medical Writer, Clinical and Regulatory Strategic Communications (CRSC)

MSD • Rahway, PA

8d

About The Position

The Clinical and Regulatory Strategic Communications (CRSC) department within Global Clinical Trial Operations (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. 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.

Requirements

• 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
• 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.
• Knowledge of ICH GCP Guidelines
• Knowledge of Regulatory Compliance
• Knowledge of Regulatory Documents
• Knowledge of Regulatory Submissions
• Knowledge of Technology Platforms

Nice To Haves

• Experience independently preparing a subset of clinical regulatory documents (e.g., protocols, clinical study reports, participant narratives, investigator’s brochures), in accordance with regulatory requirements and industry guidelines.
• Mentorship experience
• Teamwork skills
• Time Management skills
• Written Communication skills

Responsibilities

• Prepares clinical regulatory documents (e.g., protocols, clinical study reports, participant narratives, investigator’s brochures) and/or public-facing documents (e.g., informed consent forms, clinical trial registration and results postings, plain language summaries) per company and evolving regulatory requirements.
• Applies 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).
• Acts as a scientific contributor and collaborator on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities.
• Applies 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.

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days
• annual bonus
• long-term incentive

What This Job Offers

• Job Type: Full-time
• Career Level: Senior