M.Sc

More than 30,000 Takeda employees working in more than 70 countries are committed to improving quality of life for patients, who remain at the center of everything we do. Takeda Pharmaceutical Company Limited is a global, research and development-driven organization working internally and with external partners to translate science into life-changing medicines. Takeda focuses on the core therapeutic areas of oncology, gastroenterology, neuroscience and providing vaccines that address the most important infectious diseases. Novel products, especially in oncology and gastroenterology, as well as our presence in emerging markets, fuel our growth.

Post : Senior Clinical Research Associate

Job Description
Objectives
Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and Takeda requirements 

Accountabilities :  
• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with study protocol and applicable regulatory requirements
• Work with CROs to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability
• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.
• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase.
• Ensure site documents are available for filing in the Trial Master File (TMF) and verify that documents are maintained in accordance with GCP and local regulatory requirements
• Ensure 100% adherence to monitoring and study plan
• Support clinical quality in managing CAPAs and other study audit observations
• Support Clinical Operations Lead/ Clinical Operations Manager in performing CRO oversight as per agreed parameters
• Ensures adherence to study budget through constant monitoring for allocated study(ies)
• Ensures dissemination of study updates to relevant stakeholders as per agreed timelines

Candidate Profile
• Master’s or Ph. D degree in scientific discipline or healthcare with >5 years’ experience in clinical trials industry as Clinical Research Associate
• Good working knowledge of GCP and local clinical trial rules and regulations
• Organizational and problem-solving skills
• Superior communication, strategic, interpersonal, and negotiating skill
• Proven/ stable performance records over past 2-3 years

Additional Information
Experience : >5 years
Qualification : Master’s or Ph. D degree in scientific discipline or healthcare
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Research & Development
End Date : 20th May 2024

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Pfizer is the world's premier biopharmaceutical company taking new approaches to better health.  We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support.

Post : Associate I – Regulatory Conformance

Job Description 
As an associate, your focus on the job will contribute in achieving your team’s tasks and goals. This is a multifaceted role that will offer you a number of opportunities to enhance your skills. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.  It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

Job Description
• Committed to quality and excellence in compliance and conformance
• With the reasonable understanding of regional regulations, would perform the evaluation of the notifications assigned.
• Accountable for maintaining the HA status in corporate change and dossier management system for the allocated Regions / Markets
• Contributes independently and manages own time to meet the timelines.
• Work in collaboration with GRA colleagues to ensure the gaps are identified and escalated on time.
• Independently Perform accurate updates in system for most of the cases and consult with TL/Designee for clarification of any discrepancies in complex cases, before updating the system.
• Makes informed decisions on straight cases within guidelines and policies
• Support for updates in system for License withdrawals
• Operate in line with internal SOPs and policies
• Adhere to standard turnaround timelines
• Escalate any potential compliance issues to management
• Support periodic and ad-hoc system reports to estimate metrics
• Contribute to local and regional regulatory initiatives promoting a culture aligned with Pfizer values
• Assist in ensuring internal regulatory processes and procedures are well documented
• Assist in remediation activities
• Support the teams in ADHOC activities
• Shares the learning time to time with the team colleagues

Technical Skills
• Theorotical Knowledge on Regulatory Affairs / Compliance
• Experienced in Regulatory / Quality Assurance/ Production or any other functions in Pharmaceutical or related industries
• Diligence and attention to detail
• Good communication skills
• Understanding stakeholder needs
Behavioral/Any other Skills – An assertive, results oriented, positive “can do” attitude, and Time management skills. Preferred

Candidate Profile
Qualification – Master’s / Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.  Preferred Year Of Experience - 2 to 4 years of experience 
Type of Experience – Any relevant experience in Pharmaceutical or relevant industry. Experience in Regulatory or Quality or Compliance roles is preferable.

Additional Information
Experience : 2 to 4 years
Qualification : Master’s / Bachelor’s degree or equivalent
Location : Chennai
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory
End Date : 20th May 2024

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