Senior Medical Writer - Health Literacy

Job Description

The Medical Writing and Disclosure (MWD) department within Global Clinical Trial Operations 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.

In partnership with the medical writing project lead, the Senior Medical Writer leads the preparation and execution of clinical regulatory documents and public-facing documents across multiple programs and therapeutic areas in support of the company portfolio.

In this role, 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

• Bachelor's degree or higher in a scientific discipline (e.g., life sciences, pharmacy, medicine).

• At least 3 years of plain language medical writing or relevant 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.

• Experience and proficiency in independent plain language authoring such as patient- or public-facing materials, informed consents, plain language summaries, or other health-literate clinical research materials.

• Experience independently applying health literacy principles and best practices, such as translating scientific content into easy-to-understand text using health literacy and numeracy principles and sensitivity to the needs of audiences across cultures and communities.

• Demonstrated leadership in enhancing health literacy best practices and processes

Preferred skills and experience:

• Background in medical writing, authoring clinical regulatory documents (e.g., clinical study reports, protocols).

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Required Skills:

Adaptability, Clinical Data, Clinical Operations, Clinical Study Design, Clinical Trial Compliance, Clinical Trial Management, Communication, Data Analysis, Ethical Standards, ICH GCP Guidelines, Medical Writing, Microsoft