Medical Writer: Pharmaceutical

Medical Writer: Pharmaceutical Criterion Edge is seeking a fully remote candidate for the role of Pharmaceutical Medical Writer to join our best-in-class writing team and help take our customer focused writing services to new heights. This position is a 1099 Contractor position that will pay $75-$95/hour. The person for this position is not entry level or senior level, but instead somewhere in the middle. Employment Type and Location: Remote 1099 Contractor (Part Time/Full Time) Job Overview In the role of Pharmaceutical 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. 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.
• 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.

Qualifications and Skills

• 4 or more years of pharmaceutical industry experience, including 3 years of clinical and regulatory writing
• 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
• Minimum of a BSc in a life sciences or related discipline / related field.
• Independently or with minimal supervision write, edit, and perform data verification
• 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.
• 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
• Capable of working independently to achieve assigned project goals with minimal supervision.
• Excellent attention to detail and accuracy.
• Contribute, collaborate, share responsibilities, and support other team members to ensure success with tasks/projects.

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