Senior Medical Writer - EU
- Experience Level
Senior Medical (Regulatory) Writer
Open pay rate
6 month contract
APPLICANTS MUST be based in Ireland, Spain, Poland, Portugal or Czech Republic.
As the Senior Medical Writer you will research, create, and edit all documents associated with clinical research.
Responsibilities will also include: acting as primary client contact for medical writing projects, working with other departments and clients to set and meet internal/external deliverable timelines, project leadership, and training and support of junior medical writing staff.
Author Clinical Documents
- Gather, review, analyze, and evaluate 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.
- Revise document drafts based on the review comments from team members to ensure inclusion of all relevant input.
- Ensure that all work is complete and of high quality prior to team distribution or shipment to client.
- Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
Document Project Management
- Act 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 client guidelines/SOPs. Distribute final documents to project team and client.
- Attend and complete mandatory, corporate, project-specific, and departmental training as required.
- Keep abreast of professional information and technology through workshops and conferences (when approved), and assure appropriate transfer of that information to the department.
- Bachelor's degree in Life Sciences/Health Related Sciences or equivalent
- Excellent interpersonal, negotiation, verbal, and written communication skills.
- 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.
Knowledge and Experience:
- 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.