Careers
Associate Director, Medical Writer (MW-425)
Ambit Biosciences is a privately-held biopharmaceutical company engaged in the discovery and development of small-molecule kinase inhibitors for the treatment of cancer. With more than 500 distinct kinases identified and over 30 kinase inhibitors in clinical trials or FDA approved, this important class of proteins is a rich area for therapeutic drug development. Ambit Biosciences has the technology, the expertise and the vision to succeed in the kinase space. We are seeking a talented Associate Director, Medical Writer.
Responsibilities:
The Associate Director, Medical Writer will be responsible for writing, researching and editing clinical study protocols, investigator's brochures, clinical data summaries, clinical and non-clinical study reports and other medical/regulatory documents. Other key duties will include, but are not limited to:
- Serving as the primary clinical medical writing representative on development stage projects and works closely with personnel from clinical, regulatory, clinical pharmacology, DMPK, and other scientific departments as needed.
- Preparing templates for clinical documents that are consistent with Clinical Department SOPs, FDA and ICH guidelines and with electronic submission guidelines.
- Developing the strategy for clinical document preparation, including timeframes that meet or exceed company standards and the document review processes.
- Participating in the development of scientific manuscripts and abstracts reporting clinical study data, as well as slide and poster presentations.
- Supporting clinical protocol development.
Qualifications:
- Ph.D. in a scientific discipline or MD or equivalent.
- Five plus (5+) years experience in medical writing, preparing clinical protocols, IBs, abstracts, manuscripts and reviews for clinical trials for biotech/pharmaceutical companies.
- Demonstrated ability to research and review clinical content effectively and translate information into clear and concise messages using AMA style in the English language.
- Must have a strong scientific/clinical background.
- Excellent writing, editing, and oral communication skills are essential.
- Prior experience in the therapeutic areas of clinical oncology is highly preferred