ProClinical has a brilliant opportunity for a Technical Writer to be based in Dallas, Texas. This medical communications job will be with one of the largest workforce management solutions companies in the world who specialise in multiple scientific and engineering sectors.
Provides medical writing support in developing and finalizing scientific documents (e.g. study protocols and associated documents, regulatory documents for filings, clinical study reports, manuscripts) supporting pre-market studies, and post-market clinical studies.
- In conjunction with clinical study team, drafts and finalizes assigned sections of clinical study protocols and associated study documents.
- Supports development of clinical study reports, and writes subject narratives.
- Contributes to scientific publications in international peer-reviewed journals and other publications, conferences, and other media as appropriate.
- Supports development/review of SOPs and associated documentation (e.g. templates, forms, etc.).
- Provides editorial support/review to documents developed by others.
- Develops documents in appropriate format, according to established templates, regulatory guidelines, or manuscript structures.
- Follows current SOPs. Evaluates current procedures for efficiencies and quality as well as makes recommendations to management for improvements. Participates in process improvement activities as needed.
- Performs literature searches to support assignments and ensures citations are accurate and appropriate.
- Travel domestically and internationally up to 25%.
- Bachelor's degree in life sciences, communications, technical writing or related field preferred
- AMWA certification preferred.
- Minimum 3-5 years experience in medical device industry, clinical research setting, or technical writing field.
- Strong ability to communicate fluently and effectively in written and verbal English.
- Familiar with the clinical study process and documents, including introductory knowledge of common statistical methodology used in clinical studies.
- Comfortable collaborating with and presenting before groups of internal stakeholders.
- Ability to handle multiple projects/problems with overlapping timelines.
- Strong attention to detail. Ability to identify inconsistencies, errors, and deficiencies in documents.
- Excellent interpersonal skills. Ability to collaborate and build effective working relationships with co-workers, management, and customers. Strong negotiation skills.
- Knowledge and application of industry standards, best practices, and applicable country regulations (US FDA, ISO, ICH, etc.).
- Experience with Microsoft Excel, Word, PowerPoint, Outlook, Endnote, SharePoint, Project and Visio.
- Ability to follow oral and written instructions.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please send your CV to Matthew Goldberg on [click here] or upload it on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.