Remote Associate Director, Medical Writing Leader

Sarepta Therapeutics; Chicago (IL); Teletrabalho; USD 161 000 - 201 000; Tempo integral

Resumo da oferta

Sarepta Therapeutics is seeking an Associate Director of Medical Writing for a fully remote US-based role. You will independently plan, develop, and deliver high-quality clinical and regulatory documents, providing leadership and strategy for MW planning and coordination.

You will lead cross-functional teams, ensure adherence to MW processes and global regulatory guidelines, and mentor junior staff while contributing to a fast-paced, collaborative environment.

Qualificações

• Bachelor's degree in life sciences or related field.
• 10+ years of relevant experience; 8+ in medical writing.
• Strong writing skills and ability to interpret clinical data.
• Knowledge of GCP/ICH/eCTD guidelines and regulatory requirements.
• Experience with NDAs/BLAs and regulatory documents.
• Proven ability to manage multiple priorities and timelines.
• Experience working with cross-functional teams.
• Excellent interpersonal and communication skills.
• Advanced proficiency with MS Office and learning new applications.

Responsabilidades

• Plan, develop, and deliver clinical and regulatory documents.
• Provide writing strategy support to cross-functional teams.
• Lead MW processes to ensure compliance with regulations.
• Collaborate to improve documentation processes and inspection readiness.
• Maintain SOPs and MW governance documents.
• Mentor colleagues and support training of direct reports.

Conhecimentos

Writing skills

Scientific communication

Regulatory knowledge

Project management

Cross-functional collaboration

Multitasking

Attention to detail

MS Office

Timeline management

Regulatory guidelines

Formação académica

Bachelor's degree or equivalent (life sciences preferred)

Ferramentas

MS Office Suite

Electronic document management systems

Descrição da oferta de emprego

Sarepta Therapeutics is seeking an Associate Director of Medical Writing for a fully remote US-based role. You will independently plan, develop, and deliver high-quality clinical and regulatory documents, providing leadership and strategy for MW planning and coordination.

You will lead cross-functional teams, ensure adherence to MW processes and global regulatory guidelines, and mentor junior staff while contributing to a fast-paced, collaborative environment.