The Senior Medical Writer will research, create, and edit all documents associated with clinical research. Responsibilities also include : acting as primary client contact for medical writing projects, working with other Parexel departments and clients to set and meet internal / external deliverable timelines, project leadership, and training and support of junior medical writing staff.
The SMW gathers, reviews, analyzes, and evaluates pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to : briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update / aggregate reports, and integrated summaries of safety and efficacy.
It has to be ensured that all work is complete and of high quality prior to team distribution or shipment to client; referring to data consistency and integrity, publishing readiness, adherence to regulatory guidelines, compliance with departmental, corporate or client SOP's and style guidelines.
The SMW acts in the capacity of project manager / lead for medical writing projects, which may entail serving as the primary client contact, negotiating deliverable timelines, and resolving project-related issues.
Project management of contractual and financial aspects may only be performed with the guidance of medical writing management.
Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership : communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead / facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage / drive the timeline, and advance document development to approval, according to Parexel or client guidelines / SOP's.
Distribute final documents to project team and client.Qualifications
Excellent interpersonal, verbal, and written communication skills.
Ability to consistently produce documents of high quality.
Demonstrates attention to details and pro-activity.
Ability to understand all necessary steps in a project, plan ahead, and identify critical paths.
A flexible attitude with respect to work assignments and new learning; readily adapts to changes.
Ability to efficiently manage time spent on tasks and proactively identify deficiency. 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.
Ability to negotiate on behalf of medical writing to ensure resources, timelines and expectations are aligned.
Understands and satisfies client needs.
Gains trust and establish 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 industry guidelines and regulations, e.g., ICH-GCP.
Extensive clinical / scientific writing skills.
Scientific background essential; writing experience includes multiple clinical documents : study reports, study protocols, or CTD documents or similar.
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 with appropriate attention to phraseology, grammar, and punctuation.
If required to perform translation work and quality control of documents written in non-English language, proficiency in relevant language is a prerequisite.
Bachelor's degree in Life Sciences / Health Related Sciences or equivalent.
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