Deciphera Pharmaceuticals Inc.
Job Title: Associate Director/Director, Medical Writing
Job Number: 21176
Location: Waltham, MA
Deciphera Pharmaceuticals is a clinical-stage biopharmaceutical company focused on improving the lives of cancer patients by tackling key mechanisms of drug resistance that limit the rate and/or durability of response to existing cancer therapies. Our small molecule drug candidates are directed against an important family of enzymes called kinases, known to be directly involved in the growth and spread of many cancers. We use our deep understanding of kinase biology together with a proprietary chemistry library to purposefully design compounds that maintain kinases in a “switched off’ or inactivated conformation. These therapies comprise tumor-targeted agents designed to address therapeutic resistance causing mutations and immuno-targeted agents designed to control the activation of immunokinases that suppress critical immune system regulators, such as macrophages. We have used our platform to develop a diverse pipeline of tumor-targeted and immuno-targeted drug candidates designed to improve outcomes for patients with cancer by improving the quality, rate and/or durability of their response to treatment.
We are seeking an Associate Director/Director, Medical Writing to be responsible for providing Medical Writing leadership for late-stage clinical and regulatory affairs activities.
This position will report to the Vice President Regulatory Affairs & Quality Assurance and be located in the Waltham, MA office.
Deciphera offers competitive compensation, including equity-based compensation, and a comprehensive benefits package that includes medical, dental, vision, 401(k) retirement plan, life insurance, and a flexible spending account for either health care and/or dependent care.
• Coordinate document development strategies with various functional areas in Clinical Development and Regulatory Affairs to produce high quality work that is compliant with GCP and ICH guidelines
• Act as Lead Medical Writer
• Represent Medical Writing on cross-functional clinical and regulatory teams and actively participate in NDA submission planning and documentation
• Plan and coordinate work with in-house Medical Writers and outside CROs to ensure quality deliverables within assigned time frames
• Experience in development of clinical documents related to late phase studies.
• NDA experience with active contribution in planning and preparation of summary documents is required
• Bachelor’s Degree; Advanced degree (MS or Ph.D.) in a relevant scientific field preferred
• 10+ years of industry experience as a Medical Writer with experience working in a small biopharmaceutical company