Job Description

Currently hiring a Principal Clinical Regulatory Medical Writer to work r emote 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.

Education:

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

Employment is contingent on disclosure of your COVID-19 vaccination status and, if relevant, proof of vaccination.

Job Tags

Similar Jobs