PTC Therapeutics, Inc.
Contract, Document Specialist, Regulatory Affairs Operations (Project Management)
He/she is responsible for ensuring that documents are formatted in accordance with appropriate style guides and resolving technical issues with formatting. The individual will be responsible for managing and tracking eDMS workflows in coordination with Scientific Writing and Project Management teams.
The individual will provide operational support in all aspects of eCTD and non-eCTD publishing working closely with cross functional departments.
The Contract Document Specialist, Regulatory Affairs Operations supports adherence to relevant regulatory requirements and company Standard Operating Procedures (SOPs) as appropriate.
Responsibilities:
Ensures that all regulatory content and information is appropriately tracked, archived, searchable and accessible for the appropriate end users
Contributes to the development of SOPs, Work Instructions (WIs) and training materials required to support the activities.
Updates internal processes to ensure compliance with health authority requirements and expectations
Education:
Qualifications:
Demonstrated expertise utilizing the eDMS applications used for regulated document control, preferably in a pharmaceutical or biotechnology company
Expert proficiency with Microsoft Word and Adobe Acrobat
Proficiency with Microsoft Office
Excellent verbal and written communication and skills
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
Experience supporting or administering eDMS-based applications used for regulated document control, preferably in a pharmaceutical or biotechnology company. (Veeva RIM)
Experience with eCTDXPress
Project Management Professional (PMP) Certification
Travel:
0-10%
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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