Senior Manager, Medical Writing 2021-104
Department: Integrative Sciences
Employment Type: Full Time
Reference Number: 1797490
We are looking for a Senior Manager, Medical Writing to develop high-quality, scientifically accurate medical communications materials for a variety of audiences. You will be responsible for clinical protocol writing and regulatory writing. This role may also support development of manuscripts. You will partner with multiple internal groups including Clinical Development, Regulatory Affairs, Pharmacovigilance, Biometrics, and Clinical Operations, and work cross functionally to ensure the medical writing standards meet business needs and objectives as well as regulatory standards.
- Independently or with minimal supervision write, edit, perform data verification, submit for review, and obtain approval for clinical and nonclinical regulatory documents including, but not limited to, clinical protocols, clinical study reports (CSRs), investigator's brochures, and safety reports
- Perform copy editing for grammar, punctuation, style, and internal consistency
- Collaborate effectively with other functional area authors to achieve submission schedules as prioritized by senior management
- Administer QC checks to ensure documents comply with FDA guidelines
- Help develop and manage medical writing processes, SOPs, and templates for key documents
- Help manage the functional review of study documents produced by contract writers
- Keep abreast of professional information and technology through literature, symposia, and conferences
- Participate in departmental and cross-departmental initiatives. Provide innovation and be a resource for improving departmental processes. Provide expertise and guidance on document design and principles of good medical writing to department and product teams
What is Required
- Bachelor's degree, preferably in a physical science, life science, or health-related field (biology, chemistry, nursing, etc). Advanced degree (Masters, Doctorate) is a plus but not required
- 8 to 12 years of directly related experience in a pharmaceutical company or CRO environment writing protocols and clinical development documents as well as supporting documents for regulatory submission to health authorities, US and/or EU
- Minimum of 2 years of experience in the oncology medical writing
- Direct experience writing protocols from the study design phase
- Experience with SharePoint and Veeva a plus
About Mirati Therapeutics
Mirati Therapeutics is a late-stage biotechnology company whose mission is to discover, design and deliver breakthrough therapies to transform the lives of patients with cancer and their loved ones. The company is relentlessly focused on bringing forward therapies that address areas of high unmet need, including lung cancer, and advancing a pipeline of novel therapeutics targeting the genetic and immunological drivers of cancer. Mirati is using its scientific expertise to develop novel solutions in two registration-enabling programs: adagrasib (MRTX849), an investigational small molecule, potent and selective KRAS G12C inhibitor, as monotherapy and in combination with other agents, and sitravatinib, an investigational spectrum-selective inhibitor of receptor tyrosine kinases in combination with checkpoint inhibitor therapies. Mirati is also advancing its differentiated preclinical portfolio, including MRTX1133, an investigational KRAS G12D inhibitor, and other oncology discovery programs. Unified for patients, Mirati's vision is to unlock the science behind the promise of a life beyond cancer.
At Mirati, we have an unapologetic and relentless focus on our mission to transform the lives of patients with cancer and their loved ones. Patients and their families motivate us to work smarter, faster and better. We are driven by the knowledge that our efforts can one-day deliver life-saving therapies for the people who need us most. Urgency, open-mindedness, accountability and collaboration ground our work. These shared values are central to who we are, what we do and how we do it.
Our people fuel our success. They are fearless and passionate in their daily pursuit of our mission. We are committed to continuing to create a company and experience that attracts and keeps the best people. When you want your days to count and the work you do to matter, discovering and delivering potentially life-changing therapies is more than a job, it's the chance to be part of something bigger.
We believe diverse professional experiences and an inclusive culture can drive better outcomes for patients. We want employees to be authentic and use their perspectives to contribute to our mission in a meaningful way.
Mirati cultivates an environment where:
- An entrepreneurial attitude is encouraged
- Our people are empowered to speak up, embrace the gray and achieve solutions
- Diverse experiences are an important of part making the best decisions
- We laugh and have fun as a work family
No matter the role, we are unified by our passion for helping patients, and are inspired by a single vision to unlock the science behind the promise of a life beyond cancer. Together, we own Mirati's success.
Learn more at Mirati.com/careers.
Mirati is an Equal Opportunity Employer (EOE) we celebrate diverse experiences without regard to race, color, religion, creed, gender identity or expression, age, national origin or ancestry, citizenship, disability, sexual orientation, marital status, pregnancy, veteran status, membership in the uniformed services, genetic information, or any other basis protected by applicable law.
Notice to Third Party Agencies: Please note that Mirati Therapeutics Inc. does not accept unsolicited resumes from recruiters or employment agencies.