Do you want to work in an environment and culture where you can thrive, develop and advance?
A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognise our people by providing valuable benefits and a quality of life balance.
An opportunity has arisen for a Senior Medical Writer at the Consultant Level in Bangalore/Gurgaon.
- Independently authors or leads authoring, including editing of documents such as:
- Clinical study documents or documents for regulatory submission e.g., protocols, clinical study reports, patient narratives, investigator brochures
- External scientific communications e.g., manuscripts, abstracts, standard response documents, FAQs, response to authorities
- May independently author or lead authoring of complex documents such as INDs, clinical summaries and overviews, briefing documents, response to authorities, and PIPs
- Provides quality assurance and training, and may provide technical mentoring, of team members depending upon project requirement
- Supports work allocation and provides oversight to team members in execution of their project responsibilities
- As a Subject Matter Expert (SME), may provide internal advice on Development Operations services based on expertise to support business development and training
- Participates in recruitment when required
- Displays and supports Kinapse values and expected behaviours related to team working and projects
- Systematically review or perform quality control checks of documents prepared by junior colleagues against pre‑specified check‑lists and follow‑up independently until final submission, or as assigned
- Support and implement the development of project‑specific and general quality processes to ensure compliance with client and Kinapse quality standards
- Ensure personal, and support project team, compliance with client and Kinapse procedures and SOPs
- Active, continuous demonstration of the Kinapse values
- Degree, or advanced level degree in a life science discipline
- Experience and technical skills within Medical Writing or Medical Information, as a part of a pharmaceutical company or CRO
- Strong analytical capabilities, familiarity and comfort with scientific and clinical data
- Commitment to ensuring the highest quality outputs are provided, including high attention to detail
- Significant knowledge of regulatory requirements or guidance pertaining to medical writing or medical Information
- Demonstrate the ability to impart knowledge of industry or functional terminology to other team members
- Effective team member, and matrix leader for small teams
- Integrity, credibility, and commitment to building the Kinapse brand in the marketplace
- Excellent client relationship management skills, professional service mentality
If you want to be part of a progressive, forward-thinking company and want to make a difference then we want to hear from you.
We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organization. To review our D&I policy please visit https://kinapse.com/diversity-inclusion