Position Type: Regular
Position Title: Senior Medical Writer
Location: South San Francisco , CA
Company: Biotech company
Notes: Relocation provided
Position Number: 452
Career growth opportunity; well established biotech company in South San Francisco supports training and encourages individuals to realize their full potential. This is also an opportunity to work in a cross-functional team environment. Relocation support and competitive compensation provided.
Position requires writing, editing, and/or reviewing of clinical documents such as protocols, manuscripts, IB’s, CSRs, Clinical Expert Report and Clinical Overview components of the Common Technical Document. Strong understanding of all FDA and ICH guidelines as applicable to the preparation of these documents required. A key component of the job will be to identify the customers for each document, and formulate and convey key messages clearly and concisely for those customers.
Requirements:
- Minimum of 5 years of industry experience as a medical writer; an undergraduate degree in a scientific discipline, pharmacy, or medicine is preferred; an advanced scientific degree is a plus
- Ability to gather and synthesize large amounts of data and write clear, concise, and effective drug development documents
- Ability to turn data into visuals that convey the key messages and to communicate complex information effectively and accurately
- Understanding of the role of various documents relevant to drug development in an international environment
- Good team player; excellent written and verbal communication skills, and the ability to work well with others (often remotely)
- Proven document planning and project management skills, and ability to meet timelines without compromising document quality
- Ability to ensure consistency within and across documents to avoid confusion
Salary Range: Competitive
Contact: Apogee Clinical
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