|
Our job site is updated frequently. New jobs appear on the top of the Complete Job Openings Listing. However, please feel free to send your resume or an email inquiry to Jobs@JGBBioPharma.com. Then we can contact you if a good job fit arises.
Back to Jobs home
1) Publications Writing Contractor – 6 months contract (San Francisco Bay Area) MG55G
2) (Senior) Director Medical Writing – Full Time Position (San Francisco Bay Area) 55BSS
1) Publications Writing Contractor – 6 months contract (San Francisco Bay Area) MG55G
DESCRIPTION:
The medical publications writer will focus on developing content for abstracts, posters and PowerPoint presentations for medical meetings as well as full-length manuscripts for publication in peer-reviewed scientific journals.
EXPERIENCE AND QUALIFICATIONS:
- Minimum of 4 years working in a similar position for a pharmaceutical or medical device company
- Bachelor’s with higher degree preferred
To apply for a position send your resume to Jobs@JGBBioPharma.com
2) (Senior) Director Medical Writing – Full Time Position (San Francisco Bay Area) 55BSS
DESCRIPTION:
Responsible for providing leadership, technical expertise and administrative guidance to Medical Writing Group. Manages regulatory document preparation processes, standards, quality, and timeliness in support of drug development. Review and edit documents for organization, clarity, consistency, and conformance with regulatory standards. Manages full time and contract medical writers.
- Working with contributing authors, plans, writes and edits regulatory documents; carries out these and related activities with minimal supervision
- Reviews and edits documents for organization, clarity, consistency, use of English language/grammar, conformance with regulatory requirements, and scientific standards; resolves errors and inconsistencies in clinical data with Biostatistician and other project team members
- Incorporates comments into documents produced by key stakeholders, including Medical Writing and Quality Assurance audit reviews
- Keeps supervisor, team, and reviewers informed of date when documents will be ready for review; provides project managers with document status reports as needed
- Uses an electronic document management system to upload documents and share them with team members
- May provide editorial and peer-review support for other document types (e.g., manuscripts or presentations) as needed
- Participates in study and clinical team meetings and assists teams in resolving issues related to document preparation
- Stays current on medical writing best practices and regulatory guidelines. Expands knowledge/understanding of medical and scientific issues related to document development through professional associations, publications, and/or meetings
- Manage the performance of medical writing personnel who are responsible for the planning, writing, editing, compilation, review, and approval of global clinical and regulatory submission documents (including clinical study protocols and amendments, briefing books, investigator brochures, clinical study reports, and other regulatory documents)
- Provide leadership, strategic planning, and guidance related to the production of high quality clinical, regulatory, and scientific documents
- Provide administrative guidance to writers to ensure that standard processes and accepted practices are followed for developing schedules and the overall preparation of documents
- Troubleshoot medical writing technical issues and obstacles for other medical writers
- Support the development of formats and guidelines for clinical documentation
- May develop processes to support medical writing projects and write SOPs to support those processes
- Manage other medical writers, encouraging career development and increased levels of technical know-how through training and education
EXPERIENCE AND QUALIFICATIONS:
- 8-10 years for Director or > 10 years for Sr Director of medical writing/editing experience in the biotechnology, pharmaceutical, or medical device industry
- 9-12 years of drug, biologic, or medical device product development experience in the biotechnology, pharmaceutical, or medical device industry; more extensive industry experience may compensate for less medical writing experience
- Oncology writing experience preferred
- Must demonstrate a clear, high-quality scientific writing style in the English language, and be able to independently analyze and synthesize data from a broad range of disciplines
- Advanced scientific/technical reading, writing, and editing skills
- Extensive hands-on experience writing, editing, reviewing, and formatting clinical regulatory documents (e.g., clinical study protocols, clinical study reports, investigator brochures, and sections of INDs)
- Expert knowledge of Microsoft Office particularly Microsoft Word
- Advanced knowledge of Adobe Acrobat (full version, not the Reader)
- Intermediate to advanced knowledge of Microsoft PowerPoint
- Intermediate to expert understanding and use of electronic document management systems (eDMS, e.g., Livelink)
- Expert level understanding and use of electronic templates, complex table and document formatting, styles, automatic numbering (e.g., pagination, TOC)
- Extensive knowledge of FDA and ICH guidelines with respect to documents and electronic submission guidelines
- Extensive knowledge of health authority regulations, policies, and guidelines pertaining to global dossiers
- Extensive knowledge of GCP requirements and the drug development process
- Deep understanding of manuscript-writing processes for publication in peer-reviewed journals, including familiarity with external clinical publication practices and standards (e.g., ICMJE, AMA, CONSORT)
- Advanced scientific/technical reading, writing, and editing skills
- Position requires minimum of a bachelor’s degree; advanced degree in a life science is preferred
To apply for a position send your resume to Jobs@JGBBioPharma.com
|
