Medical Writer

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

📋 Description

• Create, research, edit, and coordinate the production of clinical documents pertaining to independent reviews.

• Collect, review, analyze, and assess relevant resources to prepare, develop, and finalize pertinent clinical documents for submission to regulatory authorities.

• Prepare, develop, and finalize clinical documents that are not intended for submission to regulatory authorities.

• Revise document drafts based on feedback from team members to ensure all relevant input is incorporated.

• Adhere to required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other applicable processes.

• Conduct literature searches/reviews as necessary to gather background information and training for document development.

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

• Act as the primary client contact for medical writing projects, negotiating timelines for deliverables and resolving project-related issues.

• Represent medical writing on assigned project teams and communicate content requirements.

• Coordinate and facilitate interdepartmental team reviews of draft and final documents.

• Assess progress on tasks, identify issues, facilitate resolutions, and advance document development to approval in accordance with Calyx and/or client guidelines/SOPs.

• Distribute final documents to the project team and client promptly and within agreed-upon timelines.

• Identify potential project challenges and communicate with all relevant stakeholders, including changes in timelines or out-of-scope requests, while suggesting possible resolution options.

• Ensure proper filing of applicable project documentation.

• Utilize appropriate methods and a systematic approach in the development, maintenance, control, and distribution of documents.

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

• Ensure all documentation complies with FDA/EMA or other relevant regulatory guidelines, as well as applicable SOPs.

• Provide medical editing review of draft and final documents prepared by other medical writers before internal or external distribution.

⛳️ Requirements

• Exceptional interpersonal, verbal, presentation, and written communication skills.

• Proven ability to consistently produce high-quality documents.

• A flexible attitude towards work assignments and a willingness to learn new concepts.

• Capability to manage multiple and diverse tasks enthusiastically while prioritizing workload with a keen eye for detail.

• Must possess the ability to work methodically in a fast-paced, time-sensitive environment.

• Demonstrable capacity to apply critical thinking to problems and tasks.

• Exhibits initiative and self-confidence, is adaptable, and can handle changing and evolving priorities.

• Ability to identify and implement process improvements.

• Actively engages in skills enhancement training and encourages team participation.

• Keeps current with trends, tools, technologies, techniques, processes, and documentation requirements impacting technology within the Life Sciences domain.

• A self-starter who can work independently.

• Extensive experience in clinical/scientific writing.

• Proven proficiency in using Microsoft Office products (including Word, Excel, and PowerPoint).

• Experience with tools to communicate progress to stakeholders.

• Familiarity with regulated environments.

• Understanding of Agile methodologies.

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

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

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

• Solid professional experience in a similar role.

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

• Proficient in English (both written and verbal).

🏝️ Benefits

• Medical, Dental, and Vision benefits for you and your family, including Flexible Spending Accounts (FSA) and Health Savings Accounts (HSAs).

• Paid time off policy including holidays and sick leave.

• Opportunities for internal growth and development programs & trainings.

• 401(k) program, life & accident insurance, and disability insurance.