Senior Technical Writer - Companion Diagnostics
The senior technical writer is responsible for working with cross functional development teams to write, edit, review and finalize technical documents required for regulatory submissions for Novartis companion diagnostic programs which includes but not limited to briefing books, documents for pre-IDE, IDE and PMA submissions, verification and validation protocols and reports.
Accountable for drafting, editing, reviewing and finalizing key technical documents required to support successful CDx development and for regulatory submissions.
Accountable for the quality of the documents including the document structure, the flow, the scientific and technical rationale and justifications, the accuracy, grammar, and consistency, etc. to fulfill all quality requirements for successful regulatory submissions and/or audits and/or publications.
Accountable for timely delivery of the documents to meet program objectives.
May meet program goals by overseeing external contractor resources.
Key Performance Indicators
Work with cross functional teams to successfully complete technical documents within the defined timelines to meet program objectives.
The candidate must possess a BS in a relevant scientific field, such as biochemistry, molecular biology, cell biology; A graduate (MS or PhD) in a relevant scientific field is highly desirable.
Must have at least 4 years of technical writing experience, in the IVD field and with experience in writing documents for regulatory submissions, such as IDE, PMA, and 510k submissions. Experience with drafting, reviewing, editing verification/validation protocols and reports. Knowledge of quality and regulatory compliance for IVD product development. Experience in writing manuscripts for publications in peer-reviewed journals is a plus, but not required.
Novartis is an EEO/AA employer M/F/D/V. This position will be filled at a level commensurate with experience.
About Novartis Oncology:
At Novartis Oncology, our employees worldwide share a common mission: discover and develop innovative medicines to fight cancer. We are passionate about providing a broad range of new remedies and practical solutions that change the way patients live with cancer. In the last five years, Novartis Oncology products have helped improve, extend, and save the lives of more than 2 million people with breast cancer, chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST), multiple myeloma, prostate cancer, carcinoid syndrome, and other cancers. With more than 7800 employees operating in over 50 countries, Novartis Oncology has a truly global reach. We have the advantage of extraordinarily talented and globally diverse employees who, through shared goals and different perspectives, are dedicated to improving and extending the lives of patients around the world.
Novartis Awards and Recognition:
- Working Mother’s 100 Best Companies 2012
- Barron's World’s Most Respected Companies 2012 (Novartis ranked as the most respected healthcare company)
- Fortune’s World’s Most Admired Companies 2012 and 2013 (Novartis ranked as the most admired pharmaceutical company)