Senior Medical Writer
Job summary
We are looking for a self-motivated and resilient Senior Medical Writer, ensuring timely delivery and high-quality medical writing deliverables in clinical development. Your role in ensuring quality and coordinating with multiple teams, including clinical operations, regulatory affairs, and quality assurance, will be crucial for the success of clinical projects.
Roles & Responsibilities- You will manage writing, editing and reviewing of diverse regulatory and clinical documents like clinical study reports (CSRs), clinical trial synopses, study protocols, and other medical and regulatory documents, publications, abstracts, manuscripts and other relevant literature for multiple projects at their various stages.
- You will be responsible for managing clinical document timelines, implementing standardized templates for regulatory and clinical documentation, and reviewing and incorporating relevant literature into clinical documents.
- You will also be responsible for collaborating as the primary medical writing representative on product teams working closely with clinical, regulatory, and scientific departments. You will enhance therapeutic area knowledge, experimental methods, research design, regulatory understanding, and statistical analysis.
- Key aspects of your role will include facilitation of consensus on decision-making and document finalization, as well as adherence of clinical documents to standard operating procedures, business practices, and quality standards.
Minimum work experience: 8 to 10 years of experience
Skills & attributes:
Technical Skills- Proficiency in writing, editing, and reviewing diverse regulatory and clinical documents, encompassing therapeutic area expertise, statistical analyses, protocol designs in biosimilar studies, and interpretation of complex medical and statistical data.
- Strong understanding of global regulatory frameworks in biologics, scientific and regulatory assessments, technical reading, and writing skills.
- In-depth knowledge of medical assessments in cancer trials, therapy areas, diseases, treatment options, and clinical development phases and nuances.
- Proficiency in developing abstracts, posters, oral presentations, and manuscripts, demonstrating a high level of skill in presenting complex scientific and medical information.
- Skills in negotiations and cross-cultural sensitivity, coupled with strong oral communication and interpersonal skills, essential for effective collaboration in a global regulatory framework.
- Leadership qualities coupled with effective collaboration within cross-functional teams.
- Ability to maintain objectivity for impartial decision-making in clinical document reviews.
- Strategic thinking, execution capability, and strong time management skills to work efficiently within stringent timelines.
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 CultureAsk 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/#!/
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.