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Principal Document Coordinator/ Quality Reviewer
A career at our company is an ongoing journey of discovery: our 58,000 people are shaping how the world lives, works and plays through next generation advancements in Healthcare, Life Science and Electronics. For more than 350 years and across the world we have passionately pursued our curiosity to find novel and vibrant ways of enhancing the lives of others.
United As One for Patients, our purpose in Healthcare is to help create, improve and prolong lives. We develop medicines, intelligent devices and innovative technologies in therapeutic areas such as Oncology, Neurology and Fertility. Our teams work together across 6 continents with passion and relentless curiosity in order to help patients at every stage of life. Joining our Healthcare team is becoming part of a diverse, inclusive and flexible working culture, presenting great opportunities for personal development and career advancement across the globe.
As the Principal Document Coordinator, you are a true leader that will support the Global Medical Writing Team to deliver its portfolio effectively and efficiently. You will demonstrate leadership skills in delivering in a matrix organization towards both, the team based in our R&D Hub in India and the global Medical Writing Team (support best practice, drive innovation, adhere to processes).
Your role would require you to:
- Independently oversee and conduct quality review of clinical and regulatory documents including but not limited to Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, and Clinical Summary documents
- Allocate and prioritize quality check and compliance activities
- Mentor and train the assigned new joiners/junior Document coordinators
- Participate in meetings related to key MW, QC, and compliance activities
- Collaborate cross functionally for continuous improvement of standards and best practices for medical writing
Who you are:
- Graduate degree or equivalent job experience with comprehensive Medical Writing knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
- Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide.
- In-depth knowledge of Clinical, Regulatory, and Safety documents
- Profound pharmaceutical industry experience (more than 10 years’ experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge) required.
- In-depth knowledge of ICH/Good Clinical Practices, CTD guidance, FDA regulations, and the drug development process.
- Comprehensive experience in working with cross-functional, global teams, and vendor resources across different regions and time zones.
- A flexible attitude with respect to work assignments and new learning; readily adapt to changes
What we offer: With us, there are always opportunities to break new ground. We empower you to fulfil your ambitions, and our diverse businesses offer various career moves to seek new horizons. We trust you with responsibility early on and support you to draw your own career map that is responsive to your aspirations and priorities in life. Join us and bring your curiosity to life!
Curious? Apply and find more information at https://jobs.vibrantm.com