Senior Medical Writer

This is a fully remote position, open to applicants in Arizona, +11 more states.

📋 Description

• Develop, research, edit, and oversee the production of clinical documents associated with independent reviews.

• Prepare clinical documents for submission to regulatory bodies.

• Create clinical documents not meant for regulatory submission.

• Revise drafts according to feedback from team members.

• Adhere to SOPs, templates, guidelines, regulations, client instructions, and relevant processes.

• Conduct literature searches and reviews for background information and training purposes.

• Draft or ghost-write clinical documents for more experienced medical writers.

• Assist team members to ensure documentation is precise and meets the needs of stakeholders.

• Engage in process improvement and training initiatives, including the development of SOPs, central content, guidelines, and workflow procedures.

• Contribute to marketing efforts such as white papers, abstracts, posters, and manuscripts.

• Act as the primary contact for clients on medical writing projects.

• Negotiate timelines for deliverables and address project-related challenges.

• Represent medical writing in assigned project teams and facilitate authoring team meetings.

• Coordinate and conduct interdepartmental reviews of draft and final documents.

• Assess task progress, identify issues, facilitate resolutions, and advance documents towards approval.

• Distribute final documents to project teams and clients within agreed timelines.

• Identify project obstacles and communicate them to stakeholders, proposing resolution options.

• Attend project team meetings and maintain project documentation.

• Manage project management aspects related to contracts and finances when necessary.

• Implement stakeholder engagement and communication strategies.

• Address problems, issues, resolutions, corrective actions, and lessons learned.

• Gather and utilize stakeholder feedback to assess relationship management effectiveness.

• Cultivate and strengthen customer and stakeholder relationships.

• Create, maintain, control, and distribute documents using systematic quality methodologies.

• Prepare documents for publishing readiness, ensuring consistency and integrity.

• Ensure documentation complies with FDA, EMA, and other relevant regulatory guidelines and SOPs.

• Conduct medical editing reviews of draft and final documents, including copyediting and content evaluation.

• Manage updates and distribution of quality standards.

• Perform other reasonable duties as assigned.

⛳️ Requirements

• Bachelor's Degree in a technical field (preferably Science, Pharmacy, Nursing, or another health-related discipline) or equivalent project-related experience.

• Proficient in written and spoken English.

• Proficiency in a non-English language, both written and verbal, is desirable.

• Significant professional experience in a similar role.

• Familiarity with regulatory documents in a contract research organization, pharmaceutical, or biotechnology company, or experience in clinical research/medical communications.

• Experience working in and knowledge of the life sciences sector.

• Strong understanding of industry guidelines and regulations, including ICH-GCP.

• Experience in regulated environments.

• Knowledge of Agile methodologies.

• Experience utilizing tools to communicate progress to stakeholders.

• Proven capability in using Microsoft Office applications, including Word, Excel, and PowerPoint.

• Demonstrated ability to apply critical thinking to problems and tasks.

• Consistent ability to produce high-quality documents.

• Capacity to manage multiple diverse tasks and prioritize workload with meticulous attention to detail.

• Ability to work systematically in a fast-paced, time-sensitive environment.

• Capability to identify and implement process improvements.

• Ability to negotiate on behalf of medical writing to align resources, timelines, and expectations.

• Current awareness of trends, tools, technology, techniques, processes, and documentation requirements affecting the life sciences domain.

• Ability to work independently.

• Experience with data analysis tools like Tableau or Power BI is desirable.

🏝️ Benefits

• Medical, Dental, and Vision coverage for you and your family.

• Flexible Spending Accounts (FSA).

• Health Savings Accounts (HSAs).

• Paid time off policy, including holidays and sick leave.

• Opportunities for internal growth and development programs & training.

• 401(k) plan.

• Life and accident insurance.

• Disability insurance.