Job Description

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:

1. Primary responsibility for developing and delivering accurate, high-quality scientific content within the project specifications, timeline, and budget.
2. Interacting regularly with clients, project managers, and other medical writers to ensure scientific accuracy, quality, and successful completion of projects.
3. Interpreting and analyzing complex datasets.
4. Editing content written by others; improve the clarity in others' writing and serve as a mentor to junior members of the medical writing team.
5. Lead client and internal meetings as necessary.
6. Organize own project workload and tasks, identify project needs, and adhere to project timelines.
7. Understand client expectations and work to meet those expectations through teamwork, adherence to deadlines, problem-solving, and scientific knowledge.
8. Effectively collaborate with other members of the project writing team.
9. Working with a Criterion Edge Project Manager to document your assigned tasks, time estimates, and due dates into project plans, and provide weekly progress updates.
10. Proactively identify potential project risks and bring those forward to the overall project team to discuss and identify solutions.
11. Ensure and coordinate quality control (QC) checks for accuracy following established internal QC processes.
12. Provide written and verbal feedback to junior staff and clients when appropriate.

Qualifications and Skills

1. 4 or more years of pharmaceutical industry experience, including 3 years of clinical and regulatory writing.
2. 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.
3. Minimum of a BSc in a life sciences or related discipline / related field.
4. Independently or with minimal supervision write, edit, and perform data verification.
5. Collaborate effectively with other functional area authors to achieve submission schedules.
6. 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.
7. High level of English fluency or native English speaker, with excellent oral (including presentation) and written communication, including grammatical/technical writing skills.
8. Able to interact confidently with external stakeholders.
9. Capable of working independently to achieve assigned project goals with minimal supervision.
10. Excellent attention to detail and accuracy.
11. Contribute, collaborate, share responsibilities, and support other team members to ensure success with tasks/projects.

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