Job title: Principal Medical Writer
Company: Michael Page
Job description: As the Principal Medical Writer, you are a true leader who 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).
- Independently oversee and write several clinical and regulatory documents (with a particular focus on IBs and IMPDs/INDs)
- Thoroughly analyze and critically interpret data to determine the best approach to composing each document
- Mentor and train the assigned new joiners/junior medical writers
- Standardize processes, develop and maintain quality documents and related training materials
- 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
An opportunity to work with a Growth oriented company|Work in a growth driven culture that gives you opportunities to break new ground
- Graduate degree or equivalent job experience with comprehensive Medical Writing knowledge of theories, principles and concepts, MD/PhD or advanced science degree.
- 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 Clinical, Regulatory, and Safety documents
- Ability to lead and manage the key activities including leading creation, coordination of the authoring functions, and facilitation of the review of the documents and ensuring that documents are submission-ready and finally approved
- In-depth knowledge of ICH/Good Clinical Practices, CTD guidance, FDA regulations, and the drug development process.
- Excellent written and spoken English (including medical terminology) and familiarity with AMA style guide.
- 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
Client is a premier research-intensive biopharmaceutical company in the world.
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.
Expected salary:
Location: Bangalore, Karnataka
Job date: Wed, 08 Jun 2022 22:02:29 GMT
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