Medical Writer

4 weeks ago


Hyderabad, Telangana, India Dr. Reddy's Laboratories Full time

Company Description Dr Reddy s Laboratories Ltd is a leading multinational pharmaceutical company based across global locations Each of our 24 000 plus employees comes to work every day for one collective purpose to accelerate access to affordable and innovative medicines because Good Health Can t Wait We started in 1984 with a modest investment 20 employees and a bold vision Today we have research and development centres manufacturing facilities or a commercial presence in 66 countries For nearly four decades we have stood for access affordability and innovation based on the bedrock of deep science progressive people practices and robust corporate governance As the pharmaceutical industry evolves and undergoes disruption we see an opportunity - to strengthen our core further the next steps and to build the future the new bets The Next and the New is how we aim to continue to be the partner of choice - purpose-driven future-ready and sustainable Our aim is to reach over 1 5 Bn patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy Sustainability for us means operating in a manner that respects people planet and purpose - helping us conserve precious resources serve our patients create value for stakeholders give back to society fulfil our potential and maintain our integrity and transparency Dr Reddy s maintains a work environment free from discrimination and is an equal opportunity employer We are committed to employ nurture all qualified diverse workforce without regard to race colour religion nationality sex age disability status genetics sexual orientation gender expression citizenship or any other characteristic or classification protected by applicable law s of the country we operate in We treasure every talent and recognize merit and diversity in our organization QC and formatting of clinical trial protocols informed consent forms ICFs clinical study reports CSRs investigator s 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 10-15-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 900 000 patients having benefited from our products till date Benefits Offered At Dr Reddy s we actively help to catalyse your career growth and professional development through personalised learning programs The benefits you will enjoy at Dr Reddy s 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 Reddy s why they come to work every day and they ll say because Good Health Can t 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 we re 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 https careers drreddys com



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