- Undertakes project specific activities at high quality and in defined timelines
- Authoring and/or editing of pertinent documents such as:
- clinical study documents or documents for regulatory submission i.e., clinical study reports, patient narratives, clinical summaries etc.
- external scientific communications i.e. manuscripts, abstracts, response documents, etc.
- protocol and results summaries to support clinical trial disclosure commitments
- Systematically review or perform quality control checks of documents prepared by junior colleagues against pre-specified check-list and follow up independently till final submission
- Provides quality assurance and training and mentoring of team members depending upon project requirement.
- Supports the manager in work allocation and provides oversight to team members in execution of their project responsibilities.
- Participates in meetings with client as required to understand the client’s expectations
- Establishes trust and confidence of client counterparts
- Participates in recruitment when required
Candidates should have a strong academic background in a life science discipline, extensive experience in regulatory writing either as a part of pharmaceutical or CRO Company, strong written and oral communication skills, commitment to highest quality outputs, high attention to detail, a professional service mentality, and an ability to build rapport and strong relationships with both internal and external colleagues.
What we can offer you.
Kinapse can offer you a rewarding and challenging career working with smart, ambitious, yet humble professionals. We pride ourselves on having a non-hierarchical and friendly office culture where people are prepared to go the extra mile to help one another. A competitive salary with a range of benefits.
If you want to be part of a progressive, forward-thinking company and want to make a difference we would really like to hear from you!