Principal Medical Writer

When our values align, there's no limit to what we can achieve.
 
At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

PXL is looking to hire a Principal Medical Writer ! This is a fully remote role!

Job Purpose: 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:
Accountability
Supporting Activities

• 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

• Operate as the project lead writer/submission coordinator and primary client
• Management 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
• manager with input regarding team member’s performance for employees'
• periodic performance review, and as needed

Client
Liaison/Service

• Be aware of client expectations for self and team members.
• Respond appropriately to incidents of dissatisfaction, and feed back to Medical Writing Services management.
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