16 Gcp Guidelines Jobs

As a Regulatory Medical Writer-Clinical trials (RMW-CT), you are responsible for providing regulatory affairs (RA) strategic document expertise and support to one or more therapeutic areas (TAs) as designated by leadership. You will provide support for the preparation and submission of critical RA documents and responses to health authority (HA) or sponsor information requests using available reference materials such as documentation of previous interactions with HAs and sponsors, clinical development documentation, scientific literature, and content provided by sponsor teams. You may be the lead contact for sponsor or designated HAs interactions with cross-functional teams contributing to t...

Job Title Quality Compliant and Training Manager (Clinical Trials) Business Unit Clinical Research Location: Mumbai At Sun Pharma, we commit to helping you Create your own sunshine by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community. Are You Ready to Create Your Own Sunshine As you enter the Sun Pharma world, you'll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other's journeys. Key Responsibilities This role will be responsible for oversi...

As an Experienced Study Start up Submissions Coordinator at Medpace, you will play a crucial role in the activation of investigative sites for clinical trials in India Mumbai. Your expertise will be utilized to prepare, review, and submit documents to Regulatory Agencies, ensuring compliance with applicable regulations and guidance documents. You will be the main contact for Ethical and Regulatory submission-related activities, providing guidance to global study teams and sponsors on changing regulations and compliance requirements. **Key Responsibilities:** - Perform activities within the country leading to site activations in clinical trials - Communicate with global study teams and person...

You will be responsible for the following key tasks: - Develop, write, and edit various scientific manuscripts, review articles, case studies, and conference abstracts/posters. - Prepare regulatory and clinical documents such as clinical study reports, investigator brochures, patient information leaflets, and regulatory dossiers. - Create medical communication materials including slide decks, CME content, and white papers tailored for healthcare professionals. - Collaborate effectively with researchers, clinicians, and regulatory teams to ensure accuracy, consistency, and compliance with journal/regulatory requirements. - Conduct thorough literature reviews and ensure precise referencing usi...

Working with Us Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a w...

Job Title: Clinical Quality Assurance Compliance & training Experience : 5 plus years Location: Mumbai Type: Full-time Experience Level: [Senior] Manager/Senior Manager Department: Clinical Research Department Purpose of this Role: This role will be responsible for oversight on end-to-end clinical trial activities from quality perspective. This role will be accountable for Quality Compliance (QC) activities of Clinical Trial Medical Science team and Operations team, Clinical Trial Supply Management (CTSM) team, and Clinical Data Management team by way of Review of all study related activities, processes, procedures and adherence to applicable regulations and guidelines to ensure 24x7 Inspect...

You will be responsible for creating and writing trial protocols and presenting them to the steering committee. You will identify, evaluate, and establish trial sites, as well as close them down upon completion of the trial. Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion will also be a key part of your role. Your duties will include liaising with the ethics committee to ensure the rights, safety, and well-being of trial subjects. You will be in charge of ordering, tracking, and managing investigational product (IP) and trial materials. Additionally, you will oversee and document IP dispensing inventory and reconci...

You will be responsible for planning and conducting investigator site selection audits and clinical trial study audits at investigator sites following the applicable GCP guidelines and regulations. Your duties will include reviewing subject ICF and medical records, CRF design, and standard operating procedures. You will need to issue audit reports to the investigator site staff and other study personnel and review and assess audit responses/CAPA for timely closure of audit reports. Additionally, you will be required to provide regular updates on non-compliance or major findings in clinical trials to the Head of Quality Assurance, review Clinical study reports, and offer document review comme...

About Us: Kairos R and D Solutions Pvt. Ltd. is a fast-growing Clinical Trials Organization based in Hyderabad, dedicated to providing high-quality, ethical, and efficient clinical trial services. We are committed to excellence in research and uphold the highest standards of regulatory compliance and data integrity. Job Description: We are seeking a dedicated and experienced Senior Clinical Research Coordinator (CRC) to join our dynamic team in Hyderabad. The ideal candidate will have a strong understanding of clinical trial processes, GCP guidelines, and sponsor protocols, with at least 1.5 years of hands-on experience coordinating clinical trials. FRESHERS WILL NOT BE CONSIDERED FOR THIS P...

You are invited to join ARDEM Data Services Private Limited as a Medical Data Entry professional for patient records with a minimum of 1 year of experience in medical data annotation and document review. The ideal candidate should have a background in medical or pharmaceutical sciences and possess essential skills related to medical data management, regulatory guidelines (FDA, EMA, ICH, GCP), and patient report handling. This role requires prior experience working night shifts and is a permanent work-from-home position. Key Responsibilities - Review and annotate medical documents and patient records accurately. - Apply knowledge of FDA, EMA, ICH, and GCP guidelines to data management tasks. ...

The Project Lead Pharmacovigilance position at DDReg offers a compelling opportunity for you to advance your career in pharmacovigilance project management. As a crucial member of the Project Management team, you will play a key role in overseeing and directing all pharmacovigilance services. Your responsibilities will include serving as the primary contact for clients, ensuring project activities align with client needs and regulatory requirements, and maintaining high-quality work standards to achieve client satisfaction. Your key accountabilities in this role will involve closely managing client relations by acting as the main liaison between clients and project teams. You will be respons...

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in the BFSI industry. Roles and Responsibility Conduct risk assessments and evaluations to identify potential threats to the organization. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze market trends and competitor activity to inform business decisions. Identify and report on key performance indicators (KPIs) to senior management. Provide expert guidance on risk management best p...

We are looking for a highly skilled and experienced Branch Receivable Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the daily operations of the branch's receivables, ensuring timely payments and minimizing bad debts. Develop and implement strategies to improve cash flow and reduce outstanding amounts. Collaborate with internal teams to resolve customer complaints and disputes related to receivables. Analyze financial data to identify trends and areas for improvement in the bank's receivables. Maintain accurate records and reports on receivables, including agin...

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in the BFSI industry. Roles and Responsibility Conduct risk assessments and evaluations to identify potential threats to the organization. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze market trends and competitor activity to inform business decisions. Identify and report on key performance indicators (KPIs) to senior management. Provide expert guidance on risk management best p...

We are looking for a skilled Branch Receivable Manager to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 5-10 years of experience in the BFSI industry. Roles and Responsibility Manage and oversee the branch's receivable portfolio, ensuring timely payments and minimizing bad debts. Develop and implement strategies to improve cash flow and reduce receivables. Collaborate with cross-functional teams to resolve customer complaints and issues. Analyze financial data to identify trends and areas for improvement in receivables management. Ensure compliance with regulatory requirements and internal policies related to receivables. Lead and motivate a team of professio...

We are looking for a highly skilled and experienced Field Risk Officer to join our team at Equitas Small Finance Bank Ltd. The ideal candidate will have 2-5 years of experience in the BFSI industry. Roles and Responsibility Conduct risk assessments and evaluations to identify potential threats to the organization. Develop and implement effective risk management strategies to mitigate identified risks. Collaborate with cross-functional teams to ensure compliance with regulatory requirements. Analyze market trends and competitor activity to inform business decisions. Identify and report on key performance indicators (KPIs) to senior management. Provide expert guidance on risk management best p...