Informed Consent Medical Writer

About the position 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 Medical Writer, , the review of accurate, clear, and compliant clinical, regulatory, and/or public‑facing documents in support of the company portfolio. The Medical Writer: Acquires and applies knowledge and understanding of medical writing responsibilities, including 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). Demonstrates growing competence and independence in preparing clinical regulatory (e.g., clinical study reports, participant narratives, investigator’s brochures) and/or public-facing (e.g., clinical trial registration and results postings, plain language summaries, informed consent forms) documents per company and evolving regulatory requirements. Is a contributing member on document-specific cross-functional teams and demonstrates an understanding of team and project leadership responsibilities. Collaborates and negotiates with internal and external stakeholders while planning, authoring, and leading the documents through review and final approval. Identifies & proposes solutions to challenges across the scope of work (e.g., documents, content, processes, timelines, tools). Keeps Project Leads and/or management informed and escalates, as needed, issues that could impact timelines, quality, or compliance. Applies developing knowledge of clinical development, relevant regulations, disease areas, and company products. Applies developing knowledge of medical writing-specific tools and technology platforms. Participates in initiatives to improve medical writing processes and standards.

Requirements

• Bachelor’s degree preferably in a health, scientific, or relevant discipline (e.g., life sciences, pharmacy, medicine, public health) and at least 2 years of relevant industry experience.
• Knowledge of the principles of clinical research, clinical trial design, and fundamental statistics.
• Strong attention to detail, analytical/logical thinking skills, ability to critically evaluate and interpret data, and problem-solving capabilities.
• Ability to manage multiple projects in a deadline-driven environment, working both independently and collaboratively within cross-functional teams.
• Strong oral and written communication, interpersonal, and presentation skills in order to interact effectively and tactfully with stakeholders.
• 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.

Nice-to-haves

• Experience in plain language authoring or communication, such as patient- or public-facing materials, informed consents, plain language summaries, or other health-literate clinical research materials.
• Understanding of 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.
• Background in medical writing, authoring clinical regulatory documents (e.g., clinical study reports, protocols).
• A minimum of two years of plain-language writing experience is highly preferred.

Benefits

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.
• We offer a comprehensive package of benefits.
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days.

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