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Freelance Regulatory Medical Writer (CSR)

England
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Description

- Gather, review, analyse, and evaluate pertinent resources to prepare, develop, and finalise 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.

- Follow required standard operating procedures (SOPs), templates, guidelines, regulations, client instructions and other processes, as applicable. - Perform literature searches/reviews as necessary to obtain background information and training for development of documents.

- Review statistical analysis plans and mock statistical output to determine appropriateness of content/format for clinical writing.

Contractual

6-12 months

Full FTE

Salary Negotiable

Remote
Start date
05/2022
Duration
6-12 months
From
EPM Scientific
Published at
17.05.2022
Project ID:
2386997
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