Dr. Reddy's Laboratories Ltd
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.
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Primary point of contact for TMF related activities of assigned studies and responsible for developing successful cross-functional relationships with internal and external stakeholders.
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Own end to end responsibility to completeness, Quality and Timeliness of TMF content for all assigned studies until archival.
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Effectively monitor and report on progress of the TMF to Internal and external customers.
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Oversee TMF document flow within projected timelines.
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Accomplish TMF activities in accordance with the contracted budget for TMF Management (As applicable for insourced or outsourced studies).
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Develop and cultivate CRO relationships through effective communication.Apply lessons learned to continuous improvement of documentation management practices across study teams.
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Provide feedback and guide Study Teams in order to build knowledge and awareness of good document management practices and TMF for clinical trials.
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Assess impact of potential changes to TMF specifications prior to implementation; collaborate with Project Leads and/or designee if modifications are necessary.
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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.
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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
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Primary point of contact for internal and external audits of study TMF-related queries and support the preparation of appropriate audit and inspection responses.
Post Graduate in Science, Pharmacy or Medical Degree
Established in 1984, we are a global pharmaceutical company headquartered in Hyderabad, India. Driven by our purpose of ‘Good Health Can’t Wait’, we work to provide access to affordable and innovative medicines. We offer a portfolio of products and services including APIs, generics, branded generics, biosimilars and OTC. Our major markets include USA, India, Russia & CIS countries, China, Brazil and Europe. As a company with a history of deep science that has led to several industry firsts, we continue to plan ahead and invest in future growth drivers such as access to novel molecules, digital therapeutics and consumer healthcare. As an early adopter of sustainability and ESG actions, we released our first Sustainability Report in 2004. Our current ESG goals aim to set the bar high in environmental stewardship; access and affordability for patients; diversity; and governance. For more information, log on to: www.drreddys.com.
Caution Notice: Dr. Reddy's has been made aware of candidates receiving fraudulent job opportunities from unauthorised recruiting agencies or people impersonating Dr. Reddy's leaders. These fraudulent jobs may be advertised on employment sites or mimic our careers site and company email addresses. Please know that Dr. Reddy's Laboratories has no affiliation or connection to these situations. Dr. Reddy's (and its associated/group companies) follows a formal recruitment process through its own HR department. Please report immediately in case you suspect a fraudulent job. You may raise your concern by:
Accessing https://drreddys.ethicspoint.com.
Calling on the hotline number. List of hotline numbers are available in https://drreddys.ethicspoint.com. The hotline is available 24x7 in multiple languages.
Writing to complianceofficer@drreddys.com or chiefombudsperson@drreddys.com.
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