Associate Regulatory Scientific Communications Director

🕒 March 13

🇺🇸 United States – Remote

💵 $148.5k - $209.5k / year

⏰ Full Time

🔴 Lead

✏️ Content Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

Apply Now

Find Similar Remote Jobs

Receive Emails For Remote Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Exelixis

WebsiteLinkedInAll Job Openings

1001 - 5000 employees

Founded 1994

🧬 Biotechnology

💊 Pharmaceuticals

💰 $65M Post-IPO Equity on 2012-02

Biotechnology • Pharmaceuticals

Exelixis is a biotechnology and pharmaceutical company focused on developing cancer treatments through innovative research and development. The company is committed to advancing oncology by creating impactful cancer medicines, including biotherapeutics and small molecule therapies. Exelixis places a strong emphasis on clinical trials, collaborations, and a diverse range of treatment modalities, aiming to provide hope to cancer patients. Additionally, Exelixis is dedicated to sustainability, diversity, and community support, as reflected in their corporate values and practices.

📋 Description

• Leads content development for various regulatory and clinical documents • Composes, develops, reviews, and edits content • Integrates various sources of information into a uniform style • Compiles, analyzes, and summarizes data from statistical tables • Assigns and supervises partner regulatory editors for document tasks • Proposes and manages timelines for the document development process • Oversees the assembly of appendices for regulatory submission documents • Provides writing guidance to internal teams • Peer reviews project work and training materials • Contributes to SOP and work instruction development

🎯 Requirements

• 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