Principal Medical Writer

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.

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Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.

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Manage ongoing and/or revised project documentation and correspondence.

Ensure that all work is complete and of high quality prior to team distribution or shipment to client.

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Provide technical leadership to ensure clinical data presented in summary documents is in compliance with applicable regulatory guidelines, SOPs, and goals of submission.

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.

o 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.

o 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.

o Continuously monitor overall project performance and, if necessary, identify ways to ensure that the project is completed on-time and within budget.

o 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.

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

• Provide support as appropriate to Business Development/Client Solutions and Medical Writing Services management in their efforts to win new business. Identify and solicit new business leads for Medical Writing Services, attend business development meetings, and prepare and make sales presentations to clients, if called upon.

QualificationsExcellent interpersonal, negotiation, verbal, and written communication skills.

• A flexible attitude with respect to work assignments and new learning.

• Motivation to work consistently in a fast-paced, rapidly changing environment.

• Ability to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail, e.g., organizational skills.

• Competent working in a matrix environment and values the importance of teamwork. Possesses team leadership skills and cross-cultural sensitivity.

• Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate. Presents solutions and follows through to ensure problems have been satisfactorily resolved.

• Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.

• Understands and satisfies client needs.

• Establishes a connection with the client beyond one's project, to gain repeat business and/or to widen existing scope and services. Ability to gain trust and confidence within the company.

• Provides departmental expertise and perspectives to promote prospective business opportunities; provide Parexel colleagues with pertinent information to formalize a sound business strategy.

Demonstrated understanding of clinical research, the drug development process, and applicable regulatory guidelines and regulations.

• Broad experience in preparation of all types of clinical regulatory documentation. Experience in management of complex medical writing projects.

• Knowledge of resource management and productivity metric management.

• Advanced word processing skills, including MS Office (expertise in Word); software and systems knowledge or ability to learn and adapt to various IT systems: document management systems, collaborative authoring (e.g., SharePoint), and file conversion and databases (Excel).

• Ability to travel.

• Fluent in written and spoken English.

Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.