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Inside This Issue of the Insider
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Open Jobs and Contract Opportunities
Medical Writer (Regulatory); San Francisco Bay Area
Medical Writer (Regulatory/Clinical); San Francisco Bay Area
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Jobs and Contract Opportunities
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 The jobs listed in the Biotech Ink Insider weekly newsletter come to Susan Caldwell mostly by word-of-mouth and contact with hiring managers and recruiters.
The Insider lists job and contract opportunities worldwide that are closely related to medical writing, or that have a strong writing role, regardless of their titles. Examples include biostatistician, director of clinical research, and other clinical research titles. If you receive calls about staff or contract medical writing or related positions that you aren't interested in, please forward the job information to Susan Caldwell at caldwell@biotechink.com. We'd be delighted to publish such positions in the next issue of the Insider.
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Medical Writer (Regulatory)
San Francisco Bay Area |
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San Francisco Bay Area
Contract position; client only allows W-2 work, and must be on site.
Responsibilities
- Prepares technical documents to support domestic and international regulatory submissions
- Incorporates text, graphs, charts, tables and statistical analysis
- Proofreads, circulates, edits, assembles, inspects and duplicates product submissions
Qualifications
- Bachelor degree REQUIRED, advanced degree preferred
- 5+ years experience with Clinical Regulatory Writing
Please email Lindsey Summers at lsummers(at)pharmascent.com, or call at 303-694-5482.
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Medical Writer (Regulatory)
San Francisco Bay Area |
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San Francisco Bay Area
Contract position; client only allows W-2 work, and must be on site.
Responsibilities
- Responsible for the preparation of regulatory documents for submission to regulatory authorities within subject area (clinical/safety)
- Involves working in close partnership with the medical/scientific content owners in the relevant functions
- Takes accountability for delivering regulatory documents and works effectively and closely with key content owners
- Applies document and project management expertise
- Contributes to the functional excellence of regulatory documentation (process management).
- Prepare regulatory documents in accordance with applicable regulatory guidelines/ standards/SOPs, ensuring high scientific quality & consistency with other documents where appropriate
- Liaise with document contributors to gather information (including Licensing partners where relevant)
- Plan & create timelines for the production and review of documents ensuring alignment with overall project timelines where appropriate
- Resolve issues, errors, or inconsistencies in data with contributors as appropriate
- Review documents for: organization/clarity/use of English language/grammar/scientific standards/consistency between textual presentations and listings/tabular or graphical displays
- Manage the review process, including leading/coordinating adjudication of review comments and incorporating review comments
- Ensure that the document is published in collaboration with Regulatory Operations and that the document is approved by the single accountable signatory
- Obtain and apply knowledge of company and regulatory guidelines, procedures and best practices across relevant documents
- Participate as a member of key functional/cross functional Team (s) (e.g. Regulatory Area Functional Team, Safety Team etc), ensuring that Teams adequately plan for document deliverables
- Actively contributes to best practices & continuous improvement within Regulatory Documentation
Please email Lindsey Summers at lsummers(at)pharmascent.com, or call at 303-694-5482.
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