Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Enabled by our proprietary drug discovery platform, Deciphera has developed a diverse pipeline of wholly-owned drug candidates. QINLOCK (ripretinib) is Deciphera’s switch control inhibitor developed for the treatment of fourth-line GIST. QINLOCK is approved in Australia, Canada, China, the European Union, Hong Kong, Switzerland, Taiwan, the United States, and the United Kingdom. We wholly own QINLOCK and all of our drug candidates with the exception of a development and commercialization out-license agreement for QINLOCK in Greater China. In addition to QINLOCK, we have identified and advanced multiple product candidates from our platform into clinical studies, including vimseltinib and DCC-3116.
Job Description
This is an exciting leadership opportunity for a person with passion and talent. The company believes that medical writing is a science constantly evolving in light of new regulations and technologies. The role provides the ability to influence company leaders and work on exciting fast-paced drug development programs. This is your chance to join a dynamic Medical Writing team and be part of an emerging success story driven by the company’s unwavering commitment to patients and employees.
The Role:
The Medical Writing team is looking for an experienced, self-motivated individual knowledgeable of the current MW landscape to serve as Director, Medical Writing. The individual will be responsible for managing/mentoring a group of Regulatory Medical Writers as well as serve as lead writer across programs/submissions that are part of the growing clinical pipeline.
The position reports to the Executive Director, Medical Writing and Clinical Trial Disclosure.
What You’ll Do:
- Build and mentor the regulatory Medical Writing team
- Overall responsibility for planning, implementing, and adhering to medical writing timelines and budgets.
- Represent Medical Writing on cross-functional clinical, regulatory, and submission teams and actively participate in NDA/MAA/IND submission planning and documentation
- Act as Lead Medical Writer for complex studies/documents such as master protocols
- Strong team player and a change agent who further reinforces/enhances Deciphera’s cultural values
- Excellent people management skills – not only with direct reports but also with cross functional partners and broader organization and outside agencies
- Lead/participate in significant workstreams that involve work across departments and with external vendors; may include participation in initiatives such as document templates, development of CCI, writing style guide, and support for document reviewing/authoring tools
- Coordinate and direct activities of protocol governance committee
- Experience and skill performing medical literature searches
- Developing and participating in department training and SOP development
- Performing reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings, as needed.
- Act as subject matter expert for development of data transparency initiatives and lean writing concepts
- Maintains cutting edge knowledge base of current developments in field and related technologies
- Represent Medical Writing in Inspection Readiness and participate in GCP Audits and Inspections
Qualifications
- Advanced degree (MS or Ph.D.) in a relevant scientific field. Ph.D. degree is preferred
- Minimum of 5-8 years medical writing experience with a total of more than 10 years of pharmaceutical or biotech experience
- Minimum of 2-5 years experience managing people/MW CROs
- Strong submission experience across ICH regions (NDA, NDS, MAA, IND) with active contribution in planning and preparation of summary documents
- Excellent verbal and written communication skills and attention to detail related to consistency, grammar, syntax, and accuracy
- Experience producing high quality clinical documents
- Knowledge of clinical disclosure
- Strong organizational/prioritization skills for the management of multiple concurrent documents
- Demonstrated proficiency with eCTD Starting Point templates, Smart Sheet, databases, presentation software (MS Office skills such as Teams, Outlook, Word, Excel, PowerPoint, and SharePoint), Veeva Vault, and Please Review
- Oncology experience is highly preferred
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