Trial Master File Lead

Trial Master File (TMF) Lead

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.

Job Description

• Lead TMF setup, maintenance, and close-out of various studies eTMF system as per CDISC TMF reference model, SOPs, study-specific processes and applicable regulations.
• Primary point of contact for TMF related activities of assigned studies and responsible for developing successful cross-functional relationships with internal and external stakeholders.
• Own end to end responsibility to completeness, Quality and Timeliness of TMF content for all assigned studies until archival.
• Effectively monitor and report on progress of the TMF to Internal and external customers.
• Oversee TMF document flow within projected timelines.
• Accomplish TMF activities in accordance with the contracted budget for TMF Management (As applicable for insourced or outsourced studies).
• Develop and cultivate CRO relationships through effective communication.Apply lessons learned to continuous improvement of documentation management practices across study teams.
• Provide feedback and guide Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
• Assess impact of potential changes to TMF specifications prior to implementation; collaborate with Project Leads and/or designee if modifications are necessary.
• Maintain Study Document Lists at the study, country and site levels by collaborating with all relevant Functional heads to ensure the placeholders are correctly and accurately in place for the study and all versions of documents are filed in a timely manner.
• Conduct periodic quality review of Study Document Lists at all levels and liaise with the Document Owners to ensure that all findings are addressed and remediated in a timely manner
• Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses.

Qualifications

Post Graduate in Science, Pharmacy or Medical Degree

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/#!/ 

Experience Level

Senior Level