497 Clinical Development Jobs - Page 3

Summary The Global Medical Affairs team acts as enterprise medical voice across the asset lifecycle and leads the medical strategy for the therapeutic area. Develops/ owns IEP and provides input into development while ensuring US and Int'l medical perspective is reflected. Is responsible for the implementation of medical strategies for early programs globally with focus on innovative evidence solutions including interventional studies, NIS and RWE studies and implementation science projects. Based on extensive experience in drug development will be able to lead Integrated Evidence Packages in situations with higher scientific complexity and potential regulatory challenges. Will manage the mo...

This job description is intended to provide a general overview of the job requirements when it was prepared. The job requirements of any position may change over time and include additional responsibilities not explicitly described in the job description. Publication Project Management Project manages the publication plan tactics based on strategy across compounds. Provides expertise on publication planning strategy and tactics. Works across compounds to execute the publication plans through effective collaboration with global stakeholders and local team members. Develops and maintains publication metrics/dashboards for the team and leadership. Supports publication resourcing activities. Org...

Experience: 3- 4 years of healthcare and life science domain Experience (Except PV Case processing) Responsibilities Computer literacy and good working knowledge of MS Office Demonstrates determination and applies creativity in identifying and analyzing data. Creates clear, concise written and oral communications. Effectively clean and update different client databases, learning platforms and other web-based applications for consistency. Provides input to project plan development. Create and update the resource tracking sheet and status update on regular basis. Ensures that the team understands the client s requirements and relevant information about the work that needs to be done. Demonstra...

We are looking for 4-8 years experience medical writer who will be involved in redactions/anonymization of clinical documents as part of preparation for different regulations (EMA policy 0070, Health Canada PRCI, EUCTR regulation, final rule-NIH). Candidate should be well versed with all the related regulations, perform quality review, client communication and management. Experience in preparing disclosure documents (such as Protocol Registration Form and Result Registration Form) for clinicaltrials.gov and for various other clinical registries will be added advantage. Resource should understand & comprehend protocol and clinical study report from disclosure perspective. Good understanding o...

Mentors less experienced medical writers on projects, as necessary. Compiles, writes, and edits medical writing deliverables, and serves as a medical writer within and across departments with minimal supervision. Develops or supports a variety of documents that include but not limited to: o Clinical study protocols and clinical study protocol amendments; o Clinical study reports; o Patient narratives; o Annual reports; o Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency. Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and m...

Leading and managing project teams, including defining project objectives, planning, and coordinating activities to ensure successful project outcomes. Overseeing the development and execution of project plans, schedules, and budgets, ensuring that all project milestones are achieved on time. Coordinating with cross-functional teams and stakeholders to ensure alignment on project goals, deliverables, and expectations. Monitoring project progress, identifying risks and issues, and implementing solutions to address challenges and keep the project on track. Providing regular updates and reports on project status, performance, and changes to stakeholders and senior management. Your Profile: Bach...

About Applied Medical Applied Medical is a new generation medical device company with a strong global reputation in healthcare. Our proven commitment to innovation has fueled our rapid business growth and expansion for more than 35 years, with a vertically integrated business model enabling our team members to develop technologies that enhance clinical care. We believe in the power of working together to make a meaningful and positive difference and have curated an environment where team members of diverse backgrounds are valued, challenged, and acknowledged. Our dedication to delivering the highest quality products combined with our unique business model, allows team members the ability to ...

The Director, Clinical Data Transformation & Delivery will drive enterprise-wide transformation of Lilly s clinical data strategy, partnering with senior leaders to align global functions and deliver measurable business outcomes. This leader will champion talent development, diversity, and inclusion, and serve as a change agent for digital innovation. Representing Lilly externally, the Director will shape industry standards and best practices, ensuring Lilly remains at the forefront of clinical data excellence. Roadmap influence & standards assurance Continuously scan the landscape (regulators, standards bodies, peer sponsors, vendors) and translate best practices into clear recommendations ...

Minimum 5 years of experience in Medical writing Must possess excellent communication skills and should be proficient in Microsoft Office. Should have prior experience in handling end to end project. Ability to handle SOPs, draft process maps or flowcharts Mentors and leads less experienced medical writers on complex projects, as necessary. Acts as lead for assigned writing projects. Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision. Compiles, writes, and edits medical writing deliverables including operating guidance documents, SOPs, training guides, etc., and serves as a medi...

HOW MIGHT YOU DEFY IMAGINATION If you feel like youre part of something bigger, its because you are At Amgen, our shared mission -to serve patients drives all that we do It is key to our becoming one of the worlds leading biotechnology companies We are global collaborators who achieve together researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide Its time for a career you can be proud of Join us, Biostatistics Sr Manager What You Will Do Lets do this Lets change the world, Amgen is expanding its global Biostatistics capabilities, with Amgen India (AIN) playing a key role in integrated delivery and functional leadership As a Biostatistic...

As a Clinical Modeler Technical Expert AI/ML within our Clinical Modeling and Evidence Integration team / Hyderabad, you will lead clinical modeling effort to support projects and clinical studies, develop and implement machine learning and deep learning models for clinical prediction and patient phenotyping, and promote innovative approaches and AI/ML application and industrialization. We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve peoples lives. Were also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was pos...

What you will do Let s make an impact. Let s change the world. In this crucial role, youll cultivate strong business relationships with key cross-functional team members. You may also take on the role of functional area lead on product teams, oversee writing activities for product submissions (with supervision), mentor and train junior writers, and support various departmental initiatives as needed. Roles Responsibilities: Prepare regulatory submission documents as assigned, including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Do...

The Global Medical Affairs team acts as enterprise medical voice across the asset lifecycle and leads the medical strategy for the therapeutic area. Develops/ owns IEP and provides input into development while ensuring US and Intl medical perspective is reflected. Is responsible for the implementation of medical strategies for early programs globally with focus on innovative evidence solutions including interventional studies, NIS and RWE studies and implementation science projects. Based on extensive experience in drug development will be able to lead Integrated Evidence Packages in situations with higher scientific complexity and potential regulatory challenges. Will manage the most comple...

As a Project Manager within the FSA team at ICON, you'll be instrumental in driving the timely and efficient activation of clinical trial sites across global studies. Your leadership will ensure alignment with strategic objectives, regulatory compliance, and sponsor expectations ultimately accelerating study start-up timelines and contributing to successful clinical trial execution. What you'll be doing: Driving site activation: Leading and managing the successful activation of sites from identification to IP release across multiple countries and projects. Study start-up planning: Developing, implementing, and overseeing Study Start-Up Plans, including integration into the Project Management...

Step into a role where innovation meets impact As a Digital Endpoint Expert, youll be a key member of the Digital Endpoint Capability Centre, driving the coordination, implementation, and deployment of digital endpoints and digital health technologies across clinical trials Youll bridge digital health expertise and clinical trial excellence, working closely with trial teams and cross-functional stakeholders to ensure seamless delivery Your leadership will shape the integration of novel measures across the development organization, while your expertise will help define implementation strategies tailored to each indication and trial design If you're passionate about digital health and ready to...

KRA Deliverables / Targets 1. Quality Control - Ensure correctness of all reports with necessary cross-reference from clinical history. - Communicate with concerned doctors/clients in case of highly abnormal reports. Target: 99.5% report correctness to be achieved. 2. Turnaround Time (TAT) - Monitor TAT from sample registration (accession) to report release. Target: 95% compliance at all locations. 3. Grievance Redressal - Address all grievances through re-testing or direct communication with clients/doctors, wherever required. Target: 100% resolution of reported grievances. 4. Equipment Maintenance & Calibration (CPRT) - Maintain AMCs strictly as per requirement. - Use minimum controls/cali...

Position: Biostatistician Location: Nashik Experience: Minimum 2 Years Notice Period: 15 - 30 Days Qualification: Bachelors or Diploma degree in Medical Engineering Industry: Medical / Hospitals Job Summary: We are seeking a detail-oriented and analytical Biostatistician to join our medical research and clinical team in Nashik. The role involves applying statistical methods to design, analyze, and interpret data from medical and healthcare studies to support evidence-based decision-making. Key Responsibilities: Design, develop, and implement statistical methodologies for medical and clinical research projects. Analyze biomedical data from clinical trials, laboratory research, or healthcare s...

Location Mumbai / Hyderabad, India Novartis is unable to offer relocation support for this role please only apply if this location is accessible for you, About The Role As the Clinical Research Medical Advisor (CRMA), your responsibility lies within the development of Global Clinical Trials this includes medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning, You will drive compliance across all aspects of clinical trials and CRMA related activities It will be critical to ...

Location Mumbai / Hyderabad, India Novartis is unable to offer relocation support for this role please only apply if this location is accessible for you, About The Role As the Clinical Research Medical Advisor (CRMA), your responsibility lies within the development of Global Clinical Trials this includes medical oversight for all trials, portfolio and/or protocol medical feasibility, scientific engagement of investigators, protocol and TA training for internal and external stakeholders, medical issue or question management, safety review, strategic input in pre-launch planning, You will drive compliance across all aspects of clinical trials and CRMA related activities It will be critical to ...

Step into a role where innovation meets impact As a Digital Endpoint Expert, youll be a key member of the Digital Endpoint Capability Centre, driving the coordination, implementation, and deployment of digital endpoints and digital health technologies across clinical trials Youll bridge digital health expertise and clinical trial excellence, working closely with trial teams and cross-functional stakeholders to ensure seamless delivery Your leadership will shape the integration of novel measures across the development organization, while your expertise will help define implementation strategies tailored to each indication and trial design If you're passionate about digital health and ready to...

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...

Conducting site qualification, initiation, monitoring, and close-out visits for clinical trials. Ensuring protocol compliance, data integrity, and patient safety throughout the trial process. Collaborating with investigators and site staff to facilitate smooth study conduct. Performing data review and resolution of queries to maintain high-quality clinical data. Contributing to the preparation and review of study documentation, including protocols and clinical study reports Your profile Bachelors degree in a scientific or healthcare-related field. Minimum of 2 years of experience as a Clinical Research Associate. In-depth knowledge of clinical trial processes, regulations, and ICH-GCP guidel...

Sr Manager - Gen Med Biosims International Regulatory Lead The Senior Manager of Regulatory Affairs at Amgen oversees regulatory compliance initiatives within the company. They are responsible for ensuring all company procedures and products adhere to state and federal regulatory requirements. Group Purpose International Regulatory Affairs provides regulatory leadership/ expertise for the development, registration, and lifecycle management of all Amgen molecules. Job Summary The International Regulatory Lead (Sr. Manager) is assigned to lead one or more Amgen products. The product(s) assigned have complex programs/strategies and high impact to Amgen. Provide Guidance and Leadership on mechan...

What you will do Amgen is expanding its Global Statistical Programming (GSP) capabilities, with Amgen India (AIN) playing a key role in supporting integrated delivery across regions. As an Associate Director of Biostatistical Programming (Programming Execution Lead), you will partner with Global Programming Leads (GPL) and lead a large offshore team of Study Lead Programmers (SLP) and Study Programmers (SP) to successfully execute end-to-end programming activities for all studies and global regulatory approval submissions for large, high priority products or indications across products. Together with GPL, this Associate Director will be accountable and responsible for Global Statistical Prog...

Role Description: The International Regulatory Lead (IRL) Sr Associate will provide coordination and execution of regulatory deliverables for International countries for one or more Amgen products. This role involves collaboration with various functions and local regulatory teams to optimize product development and regulatory approvals in International countries develop international regulatory strategy and provide regulatory support for in-country product registrations and life cycle management. Roles & Responsibilities: With support, advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Lia...