Principal Medical Writer, Scientific and Medical Services

Through innovative eClinical solutions and services, Calyx turns the uncertain into the reliable, helping bring new medical treatments to market faster. With deep expertise in clinical development and more than 25 years of supporting trial sponsors and clinical research organizations (CROs), Calyx harnesses that intelligence and activates its potential to solve complex problems, deliver fast insights, and get new drugs to market every day.

Calyx is looking for a Principal Medical Writer who will research, create, and edit all documents related to the independent review, including independent review charters, clinical data forms, manual case report forms, applicable reviewer training materials, project deviations, and supplemental imaging reports using all available central content and templates. The Principal Medical Writer may operate as the project lead writer and primary client contact to manage contributions of multiple writers working on related documents. This role also facilitates process improvement and technical mentoring/training and supports medical writing management during the sales process by providing client liaison and proposals input.

Responsibilities also include:Working with other Calyx departments and clients to set and meet internal/external deliverable timelinesProject leadershipTraining and support of junior medical writing staff, potentially including line managementQualificationsKnowledge 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 regulatory documentation and other documentation related to the independent review.

• 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.

• If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite.

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

• Competent working in a matrix environment and values the importance of team work.

• Possesses team leadership skills and cross-cultural sensitivity.

• Exhibits sound judgement: escalates issues to project teams or departmental management as appropriate.

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

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

• Provides departmental expertise and perspectives to promote prospective business opportunities

Education:

• Educated to degree level (biological science, pharmacy or other health-related discipline preferred), nursing or other relevant qualification/experience.