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Principal Medical Writer

Parexel International Corporation

Northeast, Remote, United States of America

Currently hiring a Principal Clinical Regulatory Medical Writer to work remote from any location in the US. (Full time)

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.

Skills:

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.

Knowledge and Experience:

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.
Must have experience as the Primary author, ( wrote majority of content, provided document project management), working on the following documents: Patient Narratives; Informed Consents; Investigator Brochures; Full Protocols; Full Clinical Study Reports; Clinical Overview (Module 2.5); Clinical summaries (Modules 2.7.3, 2.7.4; ISS, ISE); other clinical and regulatory documents.
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.