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.
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.
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.
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.
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.

• Provide strategic and project planning intelligence to Medical Writing Services

management for medical writing activities in the proposal generation process,
including assessment of scope of services to be provided to a client with respect to medical writing tasks. May attend proposal development meetings if requested by Medical Writing Services management.

• Input to development of client proposals generated by Medical Writing Services

and letters of agreement/intent based on existing templates. May function as
the client contact if requested and communicate pricing information in conjunction with Medical Writing Services management.
If requested, suggest appropriate resourcing, based on existing templates
and standards, for full-service and stand-alone projects.

Qualifications

Excellent 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).
Fluent in written and spoken English.
Bachelor’s degree in Life Sciences/Health Related Sciences or equivalent.