Responsibilities
- 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.
- 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.
- 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.
- 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.
- Keep abreast of new advances in medical writing and regulatory issues.
- Develop and train Medical Writing Services staff to enhance writing quality, efficiency, and project management.
- Attend departmental and company meetings as necessary.
- Comply with departmental procedures and requirements, such as completion of project assignment and workload trackers on the applicable software platform
Requirements
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent.
- 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 / varied tasks with enthusiasm and prioritize workload with attention to detail.
- 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.
- 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.
- Previous advanced level medical writing experience operating at either Senior or Principal Medical Writer level, being able to demonstrate broad experience in preparation of all types of clinical regulatory documentation.
- Experience with clinical study reports (CSRs), Safety narratives, study protocols and protocol amendments, common technical document (CTD) sections particularly Modules 2.5 and 2.7 is essential.
- 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 English communication skills in both written and verbal format.
Additional Information
- Role is fully home based.
- Work location options: Ireland, UK, France, Poland, Spain.
- Fluent English communication skills in both written and verbal format are required.
