Medical Writer

Job Listing ID:

4499068

Job Title:

Medical Writer Application Deadline:

Open Until Filled

Job Location:

Salem

Date Posted:

05/26/2026

Hours Worked Per Week:

Not Provided Shift:

Not Provided Duration of Job:

Either Full or Part Time, more than 6 months You may contact this employer directly. (Obtain the contact information to print or add to your jobs.)

Job Summary:

Parexel FSP has exciting opportunity for a Medical Writer with experience in non-interventional study protocols and reports. This is a fully remote role! The Principal Medical Writer will research, create, and edit all documents associated with clinical research. The Principal Medical Writer may operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. The Principal Medical Writer also facilitates process improvement and technical mentoring/training and supports Medical Writing Services management during the sales process by providing client liaison and proposals input.

Key Accountabilities :

Author Clinical Documents Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize key clinical documents for submission to regulatory authorities, without the need for any supervision or additional formal on-the-job training. Train self and provide guidance to others to prepare any type of medical writing deliverable. Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input. Manage ongoing and/or revised project documentation and correspondence. Quality Control Ensure that all work is complete and of high quality prior to team distribution or shipment to client. Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission. Project Management Operate as the project lead writer/submission coordinator and primary client contact to manage contributions of multiple writers working on related documents. Manage scope of work, timeline and project goals, technical information, and input from clients throughout the project. Develop, coordinate, and oversee work plans for individual and multiple-document delivery, to enable the team to work efficiently and effectively to meet milestones and achieve team objectives. Provide leadership and strategic planning/adjustments, delegation of responsibilities, and tasks to team members. Monitor the progress of each individual project task and assess the overall program. Ensure key information received in project or program meetings is appropriately disseminated, such that project strategy is maintained and data or key message changes are incorporated appropriately across documents. Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget. Keep client and team informed of project status. Contribute expertise as a document/cross-document specialist and content historian to analyze proposed program, studies, and related documents to deliver information required by the target audiences. Build and maintain collaborative relationships with teams/clients, leading to increased performance and a sense of inclusion. Cultivate efficient, productive, and professional working relationships to promote client satisfaction and confidence. Track actual versus planned project budget. Determine the cause of cost overruns and out-of-scope activities and recommend corrective action to medical writing management. Provide updates for each project to Medical Writing Services management, and assess forecasting and resourcing. Propose creative solutions to medical writing management to shifting timelines and staffing requirements. Communicate to writer's line manager any needs or concerns regarding level of training or performance of team members on project work. Provide line ...

Job Classification:

Technical Writers Access our statewide or regional occupation report for more information about wages, employment outlooks, skills, training programs, related occupations, and more. Compensation

Salary:

Not Provided Job Requirements

Experience Required:

 See Job Summary

Education Required:

None

Minimum Age:

N/A Gender:

N/A