Medical Writer

Calyx Institute Inc.

Job Overview

Location

Remote (US)

Job Type

Full-time

Full Job Description

📋 Description

• Create, research, edit, and coordinate the production of clinical documents related to independent review, including independent review charters, clinical data forms, manual case report forms, applicable reviewer training materials, project deviations, and supplementary imaging reports, using available central content and templates.
• Serve as a contact with clients.
• Gather, review, analyze, and evaluate relevant resources to prepare, develop, and finalize applicable clinical documents for submission to regulatory authorities.
• Prepare, develop, and finalize applicable clinical documents not intended for submission to regulatory authorities.
• Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
• Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable.
• Perform literature searches/reviews as necessary to obtain background information and training for development of documents.
• Draft and/or ghost-write clinical documents for more experienced medical writers.
• Serve as primary client contact for medical writing projects, negotiating deliverable timelines, and resolving project-related issues.
• Serve as the medical writing representative on assigned project teams, communicate content requirements, coordinate and conduct interdepartmental team reviews of draft and final documents, evaluate progress on tasks, identify issues and facilitate resolutions, and advance document development to approval, according to Calyx and/or client guidelines/SOPs.
• Distribute final documents to project team and client in a timely manner and to agreed timescales.
• Identify potential project challenges and raise with all relevant stakeholders, including changes in timelines or out of scope requests, and suggest possible resolution options.
• Attend project team meetings as required.
• Ensure appropriate filing of applicable project documentation.
• Use appropriate methods and a systematic approach in the development, maintenance, control, and distribution of documents.
• Prepare documents for publishing readiness, ensuring document consistency and integrity.
• Ensure documentation adheres to FDA/EMA or other appropriate regulatory guidelines, and / or relevant SOPs.
• Provide medical editing review of draft and final documents prepared by other medical writers before internal or external distribution.
• Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions, and other processes, as applicable.
• Implement stakeholder engagement/communications plan.
• Deal with problems and issues, managing resolutions, corrective actions, lessons learned, and the collection and dissemination of relevant information.
• Collect and use feedback from customers and stakeholders to help measure effectiveness of stakeholder management.
• Help develop and enhance customer and stakeholder relationships.
• Carry out any other reasonable duties as requested.

🎯 Requirements

• Excellent interpersonal, verbal, presentational, and written communication skills.
• Ability to consistently produce documents of high quality.
• A flexible attitude with respect to work assignments and new learning.
• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
• Must have the ability to work methodically in a fast-paced, time-sensitive environment.
• Demonstratable ability to apply critical thinking to problems and tasks.
• Shows initiative and self-confidence, is adaptable, and is able to cope with changing and evolving priorities.
• Ability to identify and implement process improvements.
• Proactively participates in skills improvement training and encourages their teams to participate.
• Maintains an up-to-date awareness of trends, tools, technology, techniques, processes, and documentation requirements that affect technology within the Life sciences domain.
• A self-starter and able to work under own initiative.
• Extensive clinical/scientific writing skills.
• Proven ability of using Microsoft Office products (including Word, Excel & PowerPoint).

🏖️ 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 time.
• Internal growth and development programs & trainings.
• 401(k) program, life & accident insurance, and disability insurance.

Skills & Technologies

GCP

Remote

$65k-93k

Degree Required

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Calyx Institute Inc.

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About Calyx Institute Inc.

Calyx Institute Inc. is a 501(c)(3) nonprofit research and education organization focused on privacy, security, and open communications. It designs and operates privacy-centric telecommunications services, including mobile data plans and VPN access, and supports open-source projects such as the CalyxOS Android distribution. Through advocacy, training, and direct service provision, the institute aims to protect individual rights in digital environments and promote accessible, secure technologies for journalists, activists, and the general public.

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