PTC Therapeutics, Inc.
Associate Director of CMC Technical Writing (Maintenance)
He/she manages direct report(s).
The incumbent works closely with Regulatory CMC Strategists, cross-functionally with internal departments and external resources on CMC Technical Writing related issues.
The Associate Director, CMC Technical Writing will collaborate on the development of CMC-related documents in accordance with all applicable regulations including, but not limited to. Good Manufacturing Practice (GCP), applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association [EMA] Clinical Trials Directives, International Congress on Harmonisation [ICH] guidelines) company Standard Operating Procedures (SOPs) and internal style guides, as appropriate.
Responsibilities:
Qualifications:
EEO Statement:
PTC Therapeutics is an equal opportunity employer. We welcome applications from all individuals, regardless of race, color, national origin, gender, age, physical characteristics, social origin, disability, religion, family status, pregnancy, sexual orientation, gender identity, gender expression, disability, veteran status or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
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