Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment.

Senior Principal Medical Writer – Publication Strategy, Planning

Medical writerMedical writerFull TimeRemoteSeniorTeam 10,001+H1B SponsorCompany Site LinkedIn

Location

Maine + 3 more

Posted

167 days ago

Salary

$95K - $175.7K / year

Seniority

Senior

Bachelor DegreeEnglish

Job Description

• Leads the clear and accurate completion of complex medical writing deliverables • Completes a variety of documents that may include clinical study protocols and clinical study protocol amendments • Adheres to established regulatory standards • Advises clients and study teams on data presentation and production strategies • Leads team document reviews and reviews documents for technical issues • Performs online clinical literature searches and complies with copyright requirements

Job Requirements

Leads the clear and accurate completion of complex medical writing deliverables
Completes a variety of documents that may include clinical study protocols and amendments
Adheres to established regulatory standards, including, but not limited to, ICH E3 guidelines
Advises clients and study teams on data presentation and production strategies
Serves as expert peer reviewer for internal team
Reviews statistical analysis plans and table/figure/listing specifications

Benefits

Health benefits to include Medical, Dental and Vision
Company match 401k
eligibility to participate in Employee Stock Purchase Plan
Eligibility to earn commissions/bonus based on company and individual performance
flexible paid time off (PTO) and sick time