PTC Therapeutics Limited
Associate Director of Scientific Writing (Creative Design)
He/she may manage direct report(s).
The incumbent works cross-functionally with internal departments and external resources on Scientific Writing related issues.
The Associate Director, Scientific Writing will collaborate on the development of clinical documents in accordance with all applicable regulations including, but not limited to. Good Clinical 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:
Works with the clinical and regulatory teams to prepare clinical documents, including, but not limited to, clinical study reports (CSRs), protocols, protocol amendments, briefing documents, Investigator Brochures (IBs), safety updates, Clinical Summaries of Safety and Efficacy, Clinical Overview, and pre-clinical study protocols and reports under strict timelines.
Provides leadership in planning and completing key regulatory submissions to US and global health authorities (including but not limited to: New Drug Applications (NDAs), Marketing Authorization Applications (MAAs), Investigational New Drug (IND) submissions, and annual reports).
Ensures key messages are clear and consistent within and across documents.
Contributes strategically and scientifically at the project and/or study team level.
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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