• , US

Company:  Confidential

Job Title: Head of Medical Writing

Job Number: 78527

Location: , US

Job Description

The Head of Medical Writing reports to the Head of Development Operations and oversees medical writing strategies and operations for clinical development programs. They collaborate with cross-functional teams and external partners to ensure writing deliverables meet GCP, GDP, patient safety, and quality standards within regulatory requirements, contractual agreements, budgets, and timelines.

Responsibilities

* Influence medical writing strategies and processes across functional areas. * Provide guidance on industry best practices and writing guidelines. * Lead the medical writing team for regulatory documents and clinical reports. * Coordinate document quality checks and adjustments based on feedback. * Maintain therapeutic area and regulatory knowledge. * Contribute to process improvements and project metrics development. * Coordinate scientific publication activities as needed.

Required Skills

* Strong communication and interpersonal skills * Team player with excellent organizational abilities * Proficiency in medical or technical writing * Customer-focused and self-motivated * Result-oriented with project management skills * Analytical and data interpretation capabilities * BS/BA in a relevant field * 10+ years in pharmaceutical R&D, including 3-5 years as a Medical Writer * Technical expertise in document development * Proficient in Microsoft software and computer skills * Knowledgeable about ICH and global regulatory guidelines * Understanding of clinical trial design and regulatory processes * Experience in Pulmonary Arterial Hypertension (PAH) is advantageous.

Application Deadline: 2024-06-03

 

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