Job Opportunity

Medical Writer (Contract)

Location: San Diego, California, United States of America
Department: Integrative Sciences
Employment Type: Contingent Worker
Reference Number: R232

Job Description Summary

  • This leadership position will be responsible for providing comprehensive expertise in authoring medical writing (MW) deliverables, partnering with internal and external groups to ensure, compliance, and promote innovative solutions for reporting deliverables for Mirati clinical program(s) 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 etc of all clinical trial information for a Mirati clinical program(s) 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.

Your Responsibilities

  • Lead internal team/external teams/consultants for delivery of high-quality documents in accordance with applicable regulations and internal requirements

  • Ensure appropriate communication and involvement across functions, internal/stakeholders to create clear accountability for high quality, multidisciplinary documents submitted to regulatory agencies

  • Ensure consistency across different documents for the Mirati clinical program

  • Provide training and communications to different medical writers working on different documents for Mirati clinical program

  • Provide training to internal stakeholders and providers regarding medical writing process, best practices and process improvements.

  • Monitor benchmarks with industry peers and across other industries to establish and update best practices and KPIs

  • Optimize and lead medical writing strategies, processes and procedures

  • Recognize and implement efficiencies identified through process improvements

  • Establish and standardize Medical Writing practices/systems/tools

  • Work with MW leadership to establish medical writing practices and efficient processes for submissions globally

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)

Pay Disclosure

Salary Range:

$40/hr - $120/hr

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).