Medical Writer
Medical Writer
Employer Active
Job Alert
You will be updated with latest job alerts via email
Share
Job Alert
You will be updated with latest job alerts via email
Job Description
- QC and formatting of clinical trial protocols informed consent forms (ICFs) clinical study reports (CSRs) investigators brochures (IBs) and clinical data summaries for phase 1-phase 3 and post-marketing surveillance studies and as per agreed timelines.
- QC and formatting of clinical modules of eCTD dossiers for global approval in developed and emerging markets with high quality and as per agreed timelines.
- Ad-hoc writing support for clinical documents such a ICFs CSRs and protocols
- CSR publishing for regulatory submissions.
- Ad hoc QC and formatting support for cross-functional teams in Medical Affairs and Clinical Development
- Support in creating and/or updating SOPs checklists and templates.
- Work collaboratively with other medical writers and cross-functional stakeholders within the Clinical Development function.
- Support Group Lead in maintaining and tracking medical writer occupancy and resourcing
Qualifications :
- M Pharm with minimum 5 years of experience in document QC and formatting within the pharmaceutical industry
- Excellent written spoken interpersonal and presentation skills
- Proficiency in editing and formatting documents using Microsoft Office and Acrobat.
- Good understanding of medical terms clinical trials and drug development process.
- Ability to analyze and interpret scientific and medical data
- Highly detailed orientated and excellent time management skills
Additional Information :
About the Department
Biologics
Currently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 1015-year time horizon.
With a robust portfolio of biosimilar products across key therapeutic areas covering US$80 Bn in innovator sales future business pipeline covers a variety of product classes and therapy areas and new modalities. Fully integrated organization with over two decades of experience in developing manufacturing and commercializing multiple biosimilar products.
With a Product Development engine that has end-to-end capabilities in-house clone development upstream and downstream process development bioanalytical development and proprietary formulation.
Supported by a Clinical and Regulatory team with experience in executing complex biosimilar programs with innovative global trial designs.
We have a proven experience in commercial-scale manufacturing across a variety of technology platforms with global quality standards and a highly competitive cost structure
Rich experience of commercializing high-quality biosimilars in multiple markets with over 900000 patients having benefited from our products till date.
Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.
Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at
Remote Work :
No
Employment Type :
Full-time
Employment Type
Full-time
