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Inside the Insider
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Open Jobs and Contract Opportunities
Senior Manager, Medical Writing; Northern California
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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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Senior Manager, Medical Writing
Northern California |
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This position is located in Northern California with a pharma company. The company offers full relocation and an excellent benefit package. You will be a major part of the company and your opinion will be valued. This is an excellent opportunity!
Duties and Responsibilities
- Responsible for writing clinical documents including protocols, IBs, and CSRs.
- Responsible for the preparation of scientific abstracts, posters, slide presentations, and manuscripts.
- Assist with the generation of regulatory submission documents including eCTD/NDA clinical summaries, IND applications, and briefing books.
- Analyze and interpret clinical study data.
- Lead document review and comment resolution meetings with cross-functional teams.
- Perform literature-based research to support writing activities.
Requirements
- BS, MS, or doctorate in a scientific or medical field
- 5+ years in the biotechnology/pharmaceutical industry; infectious disease experience and a strong understanding of microbiology a definite plus; the final title will be commensurate with the candidate's experience
- Demonstrated experience in medical writing and clinical development; has written protocols, IBs, CSRs, and preferably worked on at least one eCTD/NDA submission
- Ability to manage time and expectations in a small group setting with limited administrative support
- Exceptional oral and written communication skills
- Understands and effectively responds to multicultural communication styles and business practices with alliance partners and internal colleagues
- Flexible; adapts work style to meet organization needs
- Strong organizational abilities and experience in a multi-tasking environment
- Motivated, self-directed, and able to work autonomously and in team settings to meet aggressive organizational goals
- Dedication to quality and reliability
- Excellent computer skills (Microsoft Office Suite)
- Able to build and maintain effective partnerships, both internally and externally
- Holds self and others accountable for adherence to high ethical standards; adopts and maintains the utmost integrity and respect for colleagues at all levels
- Committed to self-development and interested in professional growth
- Able to focus and use the keyboard for extended periods of time
- Available for minimal travel, approximately 2 weeks per year
- Must be on site full time
- It is critical that candidates have the ability to analyze and draw conclusions from the data, and write crisp, blank-page narrative to accurately express findings.
- BS, MS, or doctorate in a scientific or medical field (note: this requirement is non-negotiable, ex. no journalism or English degrees etc.)
- Skilled at data analysis and interpretation of clinical study data to reach scientific conclusions
- Works well both in teams and autonomously on daily basis
- Flexible; adapts work style to meet organization needs
Contact
Please send a resume in a word attachment to sms_resume@earthlink.net.
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