Medical Writer: Pharmaceutical/Biopharma/Biotech - Criterion Edge

Medical Writer: Pharmaceutical

​​​​​Criterion Edge is seeking a remote candidate for the role of Medical Writer to join our best-in-class writing team and help take our customer focused writing services to new heights.

Employment Type and Location: Remote 1099 Contractor (Part Time/Full Time)

Job Overview

In the role of Medical Writer, you will have the opportunity to work closely with other writers, project managers and support specialists to produce a wide variety of regulatory and scientific reports, plans, and other written deliverables for pharma/biotech clients.

The ideal candidate is a writing professional looking to build on their relevant medical writing experience, scientific knowledge, and well-developed written and oral communication skills. We value proactive thinkers with the ability and desire to work in a multifunctional team setting, producing documents and reports that align with the highest regulatory, scientific and professional standards.

Roles and Responsibilities

As a member of our project writing team, you will be responsible for producing assigned written documents and reports to a high standard. Your specific responsibilities include:

• Primary responsibility for developing and delivering accurate, high-quality scientific content within the project specifications, timeline, and budget
• Interacting regularly with clients, project managers, and other medical writers to ensure scientific accuracy, quality, and successful completion of projects
• Interpreting and analyzing complex datasets
• Editing content written by others; improve the clarity in others' writing and serve as a mentor to junior members of the medical writing team
• Lead client and internal meetings as necessary
• Organize own project workload and tasks, identify project needs and adhere to project timelines.
• Understand client expectations and work to meet those expectations through teamwork, adherence to deadlines, problem-solving and scientific knowledge.
• Effectively collaborate with other members of the project writing team.
• Working with a Criterion Edge Project Manager to document your assigned tasks, time estimates and due dates into project plana, and provide weekly progress updates.
• Ensure all data presented in the document are clear, complete, accurate, and concise. Ensure all statements and conclusions are integrated, balanced, supported by appropriate data, and consistent across all related documents.
• Receive expert/scientific review comments and adjust the document content as required based on internal and external feedback.
• Stay abreast of current medical writing best practices and relevant regulatory knowledge.
• Proactively identify potential project risks and bring those forward to the overall project team to discuss and identify solutions
• Ensure and coordinate quality control (QC) checks for accuracy following established internal QC processes.
• Provide written and verbal feedback to junior staff and clients when appropriate.
• Serve as a project mentor to assist in the training and development of junior staff on your project team(s).
• Establish and maintain effective, professional working relationships with co-workers, managers, and clients.
• Demonstrate initiative and sound judgement when faced with less familiar project requirements and/or document situations or challenges.

Qualifications and Skills

• 4 or more years of biopharmaceutical industry experience, including 3 years of clinical and regulatory writing
• Minimum of a BSc in a life sciences or related discipline / related field.
• Independently or with minimal supervision write, edit, and perform data verification
• Submit for review, and obtain approval for clinical and nonclinical regulatory documents including, but not limited to, clinical protocols, clinical study reports (CSRs), investigator's brochures, and briefing books
• Collaborate effectively with other functional area authors to achieve submission schedules
• Advanced word processing skills, including Microsoft Office (including Word), Adobe Acrobat, Excel and collaborative document sharing platforms such as SharePoint; ability to learn and adapt to various IT systems.
• Familiar with all current and applicable guidelines and regulations governing the assigned project.
• High level of English fluency or native English speaker, with excellent oral (including presentation) and written communication, including grammatical/technical writing skills.
• Able to interact confidently with external stakeholders and communicate with others effectively and clearly.
• Capable of working independently to achieve assigned project goals with minimal supervision.
• Reliably produce high-quality written deliverables in accordance with customer and project requirements and agreed timelines.
• Excellent attention to detail and accuracy.
• Contribute, collaborate, share responsibilities, and support other team members to ensure success with tasks/projects.
• Demonstrate scientific rigor and understanding of the scientific process in written documents.
• Assess complex situations, determine root causes, propose, and implement appropriate solutions.

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