Job Opportunity

Senior Medical Writer

Job Description Summary

We are looking for a Sr. Medical Writer 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. 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.

Your Responsibilities

• 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

• 5+ 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

Salary Range: 
$80,000 - $125,000

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

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