Director, Medical Writing Operations Lead
Employment Type: Full Time
Reference Number: 2081188
Job Description Summary
This leadership position will be responsible for providing comprehensive, operational expertise in formatting and editing medical writing (MW) deliverables, document quality control (QC), Data Disclosure, and vendor quality standards, partnering with internal and external groups to provide operational support and to ensure, compliance, and promote innovative solutions for reporting deliverables supporting the Clinical Development organization.
The role will strategize with MW leadership in building the framework to support integration of enterprise medical writing requirements such as clinical protocol writing, regulatory writing, as well as quality control of all clinical trial information that originates in the Clinical Development organization.
You will develop, implement, and maintain state-of-the-art medical writing processes and capabilities to improve quality and execution of Mirati's scientific documents. You will play a critical role in the success of Mirati's strategy to improve efficiencies and enable enhanced capabilities to delivering scientific documents. You will partner with multiple internal groups including Clinical, Regulatory Affairs, Pharmacovigilance, Biometrics, Clinical Operations and Medical Affairs and work cross functionally with other leaders to ensure the medical writing standards meet business needs and objectives as well as regulatory standards.
- Lead internal team/external teams/consultants for delivery of high-quality documents formatted in accordance with applicable regulations and internal requirements
- Lead internal team/external teams/consultants for quality control review of documents in accordance with applicable regulations and internal requirements
- Support and lead efforts for Data disclosure/transparency and Data privacy (deidentification)
- Establish and standardize Medical Writing practices/systems/tools
- Identify, develop, and integrate new technologies into Medical Writing (i.e. semi-automatic generation of document component text, specifically involving "content reuse" in automated CSR and narrative writing, and redaction functionality)
- Optimize and lead medical writing strategies, processes and procedures
- Provide training and communications to internal stakeholders and providers regarding medical writing process, best practices and process improvements.
- Ensure appropriate communication and involvement across functions, internal/stakeholders to create clear accountability for high quality, multidisciplinary documents submitted to regulatory agencies
- Establish medical writing practices and efficient processes for submissions globally
- Monitor benchmarks with industry peers and across other industries to establish and update best practices and KPIs
- Recognize and implement efficiencies identified through process improvements
What is Required
- Master's Degree in a scientific discipline. Doctorate degree preferred.
- At least 12 years of experience in pharmaceutical or biotech industry in medical/regulatory writing operations including at least 4 years of experience leading teams
- Strong background showing progressive MW operations, experience, including staff management
- Previous outsourcing management experience preferred
- Ability to understand and utilize new technology and new systems in medical writing
- Experience with ICH, eCTD, submission requirements for clinical/research reports, along with an understanding of electronic submissions requirements
- Strong written/verbal communication skills, detail-oriented nature
- Excellent leadership and influencing skills
- Demonstrated project management skills
- Ability to provide direction with cross-functional teams in a matrixed team environment
- Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook)
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 KRASG12C 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 KRASG12D 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.