Director, Global Medical Writing (Fully Remote)

Deciphera; United States; Remote; USD 150,000 - 210,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Parental leave

Comprehensive benefits package

Job summary

Deciphera is seeking a senior Lead Medical Writer to drive medical writing for clinical programs, including protocols, investigator brochures, and study reports, in the United States. You will represent medical writing on cross-functional teams for NDA/MAA/IND submissions, shape document strategies, and mentor staff while ensuring top-quality deliverables.

The role requires an advanced degree with 8–10 years of medical writing experience and a deep knowledge of global regulatory submissions and

Qualifications

• MS or PhD in a relevant scientific field with 8–10 years of medical writing experience.
• Expert knowledge of global regulatory submissions and eCTD starting point templates.
• Strong communication and organizational skills with ability to prioritize work.

Responsibilities

• Lead medical writing for clinical programs, including protocols, investigator's brochures, and clinical study reports.
• Represent medical writing on cross-functional teams for NDA/MAA/IND submissions and drive document strategies.
• Manage and mentor team members, and perform reviews of medical writing deliverables.

Skills

Regulatory submissions expertise

eCTD templates

Communication skills

Organizational skills

Mentoring

Education

MS or PhD in a relevant scientific field

Tools

Regulatory software

Job description

• Lead medical writing for clinical programs, including protocols, investigator's brochures, and clinical study reports.
• Represent medical writing on cross-functional teams for NDA/MAA/IND submissions and drive document strategies.
• Manage and mentor team members, and perform reviews of medical writing deliverables.

Qualifications:

• Advanced degree (MS or PhD) in a relevant scientific field with 8-10 years of medical writing experience.
• Expert knowledge of global regulatory submissions and eCTD starting point templates.
• Strong communication, organizational, and prioritization skills with proficiency in relevant software.
• Competitive salary and annual bonus, plus a comprehensive benefits package.
• Medical, dental, vision insurance, and a 401(k) retirement plan with company match.
• Generous parental leave and family planning benefits.

Deciphera

Deciphera is a biopharmaceutical company dedicated to developing innovative medicines for people living with cancer. They value diversity and offer a competitive compensation and benefits package, fostering a culture of collaboration and professional growth.