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: 

• 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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