Director, Medical Writing Operations
Department: Integrative Sciences
Employment Type: Regular
Reference Number: R56
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)
$200,000 - $266,000
The salary range listed in the job posting reflects the anticipated base pay range for this role in the United States. Actual base pay decisions consider a variety of factors including, but not limited to, an individual’s skills, qualifications, and experience. In addition to a competitive base salary, this role is currently eligible for our annual discretionary bonus program and annual equity awards (roles on a sales-incentive commission plan will not be eligible for our annual discretionary bonus).
Mirati employees (and their families) are provided a competitive benefits package including:
- Comprehensive healthcare coverage – multiple medical plan choices with an employer-funded HSA, dental & vision
- Company provided life insurance and disability coverage
- 401(k) retirement plan with a 6% company match and immediate vesting
- Employee Stock Purchase Plan with a 15% discount
- Extensive time off – holidays, PTO and two, week-long paid breaks in the summer and winter