PTC Therapeutics, Inc.
Senior Manager, Scientific Writing - Quality Control Review (Maintenance)
The Senior Manager, Scientific Writing - Quality Control Review, collaborates 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.
The incumbent works cross-functionally with internal departments and external resources on Quality Control Review related issues.
Primary duties/responsibilities:
KNOWLEDGE/SKILLS/ABILITIES REQUIRED
* Minimum level of education and years of relevant work experience.
* Special knowledge or skills needed and/or licenses or certificates required.
*Special knowledge or skills and/or licenses or certificates preferred.
* Travel requirements
0-10%
*Physical requirements (only note if the job requires physical capacity beyond general office work)
Office-based or remote
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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