BS/BA degree in related discipline with a minimum of eleven years of related experience, or MS/MA degree with a minimum of nine years, or PhD with a minimum of five years, or equivalent combination of education and experience
Active AMWA member with certificate or certification preferred; BELS certification a plus
Experience in Biotech/Pharmaceutical industry preferred
Prior regulatory/medical/technical writing experience
Experience and significant participation in leading content development for regulatory and clinical documents for regulatory submissions
Experience and use of electronic literature tools
Familiarity with therapeutic area of oncology
Advanced knowledge of the drug development process and regulatory requirements
Advanced knowledge of AMA style, medical terminology, and clinical data analysis
Strong interpersonal skills

Benefits

401k plan with generous company contributions
Group medical, dental and vision coverage
Life and disability insurance
Flexible spending accounts
Discretionary annual bonus program
Opportunity to purchase company stock
Long-term incentives
15 accrued vacation days in first year
17 paid holidays including a company-wide winter shutdown in December
Up to 10 sick days throughout the calendar year

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

regulatory writingclinical writingdata analysiscontent developmentSOP developmentmedical terminologyclinical data analysisAMA styledocument editingstatistical analysis

Soft Skills

interpersonal skillsleadershipcommunicationsupervisionproject managementwriting guidancepeer reviewteam collaborationorganizational skillstimeline management

Certifications

AMWA certificationBELS certification