Executive Director, Medical Writing

Summary

Join Syndax Pharmaceuticals as an Executive Director of Medical Writing and lead the Medical Writing Team. You will provide scientific, leadership, and operational expertise, overseeing the creation of high-quality, regulatory-compliant clinical documents. Responsibilities include managing the medical writing function, ensuring document quality and regulatory compliance, leading process improvement initiatives, and collaborating with internal and external stakeholders. The ideal candidate possesses an MS with 12+ years (or BS with 15+) of medical writing experience in pharmaceuticals, including 5+ years of people management. Expertise in drug development, clinical research, and regulatory requirements is essential. Syndax offers a competitive compensation package, including base pay, equity, annual bonuses, and benefits.

Requirements

• MS with 12+ (or BS with 15+) years of medical writing experience in the pharmaceutical industry; at least five years of people management experience
• Expertise in drug development, clinical research, medical terminology, study design, and the regulatory requirements for clinical and regulatory documents
• Extensive experience in medical writing with progressive leadership experience and experience in a pharmaceutical/biotech company
• Expertise in the preparation of key clinical and regulatory documents
• Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system
• Ability to work both independently and collaboratively with a team in a cross-cultural, geographically disbursed environment
• Demonstrated leadership and problem-solving abilities, a sense of urgency, and an ability to prioritize tasks, work simultaneously on multiple projects, and complete high-quality documents according to tight timelines
• Experience in resolving conflicting editorial opinions expressed by team members
• Experience leading teams/people to prepare clinical and regulatory submission documents
• Demonstrated experience mentoring and managing the project work of other medical writers
• Experience working with all levels of management and consulting with key business stakeholders. An ability to influence greater outcomes
• Strong team player that has a customer service approach and is solution oriented
• Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors
• Possesses strong written and verbal communication skills

Responsibilities

• Provides leadership and oversees management of the medical writing function, building consistent processes to optimize utilization of resources aligned with company priorities
• Ensures Medical Writing activities and provision of deliverables are linked to program strategy by providing leadership and strategic input to projects/study teams at the organization level
• Ensures that documents meet quality standards in terms of scientific content, organization, clarity, accuracy, format, and consistency, and adherence to regulatory requirements and company guidelines/styles/processes
• Ensures that all activities are conducted in compliance with relevant regulatory requirements
• Leads medical writing team in designing and maintaining templates and standards for clinical documents in accordance with ICH guidelines and medical writing best practices. Ensures consistent support and implementation of medical writing standards across all Syndax’s pre-clinical and clinical programs
• Oversees documents created and edited by the Medical Writing function to ensure compliance with GCP, ICH guidelines, and eCTD requirements, and adherence to Syndax’s SOPs and style guide
• Creates, maintains, manages, innovates, and continuously improves medical writing procedures and SOPs; proactively identify opportunities to improve systems and processes and autonomously leads process improvement initiatives within the medical writing space
• Building and maintaining relationships with internal and external customers - playing a key role in business development-related activities and attending client meetings, writing and reviewing proposals, pricing deliverables, attending bid defense meetings, and contributing to contracts and work orders
• Developing financial forecasts, and monitoring revenue, costs & utilization. Providing regular business updates to senior leaders
• Responsible for driving and promoting organizational process improvement initiatives and creating an environment across the team that encourages others to initiate process improvements
• Collaborates cross-functionally with internal colleagues to improve quality and efficiency across projects and across the organization

Preferred Qualifications

Specific experience in oncology is ideal

Benefits

• Our overall package also includes an equity offering, annual target bonuses, and an outstanding benefits program
• The anticipated annualized salary range for this role is $290,000 - $315,000