353 Clinical Development Jobs - Page 2

Role Description: The International Regulatory Lead (IRL) Manager will provide regulatory leadership & expertise 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: Advises Global teams on regulatory implications and requirements relevant to the global clinical development, Marketing Applications plans and objectives. Provides regulatory direction/expertis...

It is key to our becoming one of the world's leading biotechnology companies. We are global collaborators who achieve togetherresearching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It's time for a career you can be proud of. Join us. Prepare and oversee the review and approval of scientific and regulatory submission documents. Serve as functional area lead on product teams. Maintain key business relationships with cross-functional product team members and appropriate management staff across the Amgen R&D organization. Provide expertise and guidance on document design and principles of good medical writing to individual staff, the depart...

At Elanco (NYSE: ELAN) it all starts with animals! As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We re driven by our vision of Food and Companionship Enriching Life and our approach to sustainability the Elanco Healthy Purpose to advance the health of animals, people, the planet and our enterprise. Making animals lives better makes life better join our team today! Research Scientist Toxicology Global Non-Clinical Development We are seeking an experienced non-clinical toxicology / safety scientist to join the Global Non-Clinical Development team in Global Clinical Development. Thi...

We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program. We are committed to our Total Self culture where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people. We are continuously building the company we all want to work for and our customers want to work with. WhyBecause when we bring together diversity of thoughts, backgrounds, cultures, and perspectives we re able to create a place where everyone feels like they belong.

As a Safety & Pharmacovigilance Specialist I at Syneos Health, you will play a crucial role in ensuring the safety and well-being of patients participating in clinical trials and post-marketing programs. Your responsibilities will include entering information into PVG quality and tracking systems, preparing project plans, processing ICSRs according to SOPs, and generating accurate reporting of expedited reports in compliance with regulatory requirements. You will be responsible for triaging ICSRs, evaluating data completeness and accuracy, entering data into safety databases, compiling narrative summaries, and assessing information to be queried. Additionally, you will participate in activit...

You are an experienced Associate Director - Biostatistics who will be joining a leading client in the pharmaceutical industry. Your role will be crucial in clinical development, involving tasks such as contributing to trial design, analysis planning, interpretation of results, and regulatory submissions. Your key responsibilities will include collaborating on innovative and efficient clinical trial designs to ensure alignment with study objectives. You will independently author and review protocols, statistical analysis plans, and clinical study reports. Providing statistical leadership in regulatory interactions, publications, and presentations will also be part of your role. Additionally, ...

Candidate with min 6 months - 1year of experience of clinical Trial Disclosure or CTT Should have good experience protocol registration, result registration Should have excellent communication and client mgt experience. Compiles, writes, and edits medical writing deliverables, and serves as medical writer within and across departments with moderate supervision. Develops or supports, a variety of documents that include but not limited to: Clinical study protocols and clinical study protocol amendments; Clinical study reports; Patient narratives; Investigator brochures. Reviews statistical analysis plans and table/figure/listing specifications for appropriate content and for grammar, format, a...

Sr IPG Reporting Analyst - India, Chennai - Hybrid, Office-Based ICON plc is a world-leading healthcare intelligence and clinical research organization. We re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development We are currently seeking an IPG Senior Reporting Analyst to join our diverse and dynamic team. As an IPG Senior Reporting Analyst at ICON, you will play a key role in providing advanced analytical support to the Investigator Payments Group (IPG), developing complex reports and insights that inform strategic decision-making. You will work closely with cross-functional teams ...

Sr IPG Reporting Analyst - India, Chennai - Hybrid, Office-Based We are currently seeking an IPG Senior Reporting Analyst to join our diverse and dynamic team. As an IPG Senior Reporting Analyst at ICON, you will play a key role in providing advanced analytical support to the Investigator Payments Group (IPG), developing complex reports and insights that inform strategic decision-making. You will work closely with cross-functional teams to enhance data visibility and drive operational improvements, ensuring the effective use of data across the organization. What You Will Be Doing: Designing and developing sophisticated reports and dashboards to monitor IPG performance, payment cycles, and ke...

: Develops and implements submission strategies for 505(b)(2), ANDAs and NDAs. Leads and ensures implementation of the planning, writing and review of all regulatory submissions to support of all global projects for ANDAs and 505(b0(2) NDAs and EU and UK Marketing Authorizations. Critically reviews and approves documentation from clinical development, non-clinical development, Research and Development (R&D), Quality, Technical Operations, Labeling and other appropriate departments, internal and stakeholders, vendors and consultants. Ensures that project timelines are developed and communicated; evaluates changes to maintain submission goals and timelines; communicates any delays along with t...

Career Category Research Job Description HOW MIGHT YOU DEFY IMAGINATION If you feel like you re part of something bigger, it s 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 world s leading biotechnology companies. We are global collaborators who achieve together - researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It s time for a career you can be proud of. Join us. Senior Director Biostatistics What you will do Let s do this. Let s change the world. Amgen is expanding its global Biostatistics capabilities, with A mgen India (A IN ) playing a key role ...

Career Category Regulatory Job Description At Amgen, if you feel like you re part of something bigger, it s because you are. Our shared mission to serve patients living with serious illnesses drives all that we do. Since 1980, we ve helped pioneer the world of biotech in our fight against the world s toughest diseases. With our focus on six therapeutic areas Oncology, Inflammation, Obesity, General Medicine, Biosimilars, and Rare Disease we reach millions of patients each year. As a member of the Amgen team, you ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winni...

We are seeking a highly organized and detail-oriented Clinical Trial Coordinator (Fresher) to join our dynamic clinical research team. In this role, you will play a crucial part in ensuring the successful execution of our clinical trials from start to finish. You will collaborate with a multidisciplinary team of researchers, investigators, and study personnel to coordinate all aspects of clinical trial operations. Key Responsibilities: Study Coordination: Coordinate the day-to-day activities of assigned clinical trials, ensuring adherence to protocols, timelines, and regulatory requirements. Site Management: Assist in site selection, initiation, monitoring, and close-out activities. Document...

As the Lead Medical Writer at Tatvacare, you will be responsible for developing and reviewing high-quality medical content, including scientific publications such as original research articles, consensus reports, review articles, and clinical trial documentation. Your role will involve collaborating with cross-functional teams, providing scientific expertise, and ensuring compliance with regulatory and industry standards. The ideal candidate for this position will have extensive experience in medical writing, particularly in clinical development, regulatory affairs, and digital health research. Your key responsibilities will include developing and finalizing medical writing documents, coordi...

The Safety & PV Specialist position in Dalian at Syneos Health offers you the opportunity to be part of a leading biopharmaceutical solutions organization dedicated to accelerating customer success. At Syneos Health, we focus on translating clinical, medical affairs, and commercial insights into impactful outcomes that address the challenges of the modern market. Our Clinical Development approach places the customer and patient at the core of our operations. We are committed to simplifying and optimizing our processes to enhance both our ease of collaboration and our dedication to our mission of changing lives. Whether you choose to work with us through a Functional Service Provider partners...

As a Clinical Research Associate II (Sponsor dedicated) in Athens Homebase at Syneos Health, you will play a crucial role in ensuring site compliance with regulatory guidelines and protocol requirements. Your responsibilities will include performing site qualification, initiation, monitoring, management activities, and close-out visits either on-site or remotely. You will assess site performance, provide recommendations, and escalate any serious issues to the project team promptly. Your attention to detail will be essential as you verify the informed consent process, assess factors affecting subject safety, and review clinical data for accuracy and completeness. You will conduct source docum...

As a Site Activation Specialist I at Syneos Health in Beijing/Shanghai, you will be responsible for ensuring the quality of deliverables at the country level, adhering to project requirements and applicable country rules under the oversight of the SSU Country Manager. Your role will involve working within forecasted submission/approval timelines, tracking milestone progress in real-time, and providing clear rationale for any delays while assisting in developing contingency plans to mitigate impacts. You will also monitor basic financial aspects of the project, escalate discrepancies promptly, and comply with Standard Operating Procedures (SOPs) and Work Instructions (WIs) while keeping train...

You will be working at Silmed Scientific, an organization dedicated to public health safety through scientific evaluation and assessment of healthcare products. The company aims to ensure the global availability of safe products and fosters a unique working culture. As a Regulatory Medical Writer at Silmed Scientific, your primary responsibilities will include: - Authoring and reviewing Regulatory submission documents for pharmaceutical marketing authorization in Europe and the United States. - Developing Common Technical Document (CTD) modules like nonclinical and clinical overviews & summaries (Module 2.4, 2.5, 2.6, and 2.7), expert reports, safety & efficacy summaries, as well as Aggregat...

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually expand its broad commercial product portfolio and robust late-stage pipeline. The company s patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com . Azurity Pharmaceuticals is proud to be an inclusive workplace...

The individual contributor in this role is responsible for managing both in-house and outsourced studies, ensuring alignment with BMS outsourcing strategies within specific therapeutic areas. This position involves supporting clinical trial vendor partnerships across various service categories in R&D. You will drive outsourcing activities by collaborating with operational teams, support groups, and service providers to facilitate the selection, contracting, and execution of outsourced studies. It is crucial to ensure compliance with regulatory standards, ethical practices, and BMS outsourcing and procurement policies. Meeting short-term objectives and adhering to project schedules are essent...

As a Clinical Research Medical Advisor (CRMA) at Novartis, located in Mumbai, you will play a crucial role in overseeing all clinical and medical aspects related to Development and prioritized Research programs/trials in the country. Your responsibilities will include providing clinical strategic and tactical leadership, ensuring optimal clinical trial implementation, and upholding safety standards and clinical data quality. Your key responsibilities will involve offering clinical development and indication expertise specific to the country/cluster, validating study designs, contributing to scientific/clinical/medical aspects during the start-up phase, providing clinical/medical expertise to...

Job Summary: The Officer - Onco Solid Oral will be responsible for supporting clinical development activities related to solid tumor oncology therapies, specifically focusing on oral drug formulations. This role involves coordinating clinical trials, liaising with cross-functional teams, ensuring regulatory compliance, and contributing to project timelines and deliverables. Key Responsibilities: Assist in planning and execution of clinical trials for oral oncology products targeting solid tumors. Coordinate with clinical research organizations (CROs), investigators, and internal teams. Monitor trial progress, ensure adherence to protocols, and manage documentation. Support regulatory submiss...

At Saleshandy, we help businesses scale outbound sales with automation, personalisation, and precision Were a fast-growing, bootstrapped SaaS company trusted by 4,000+ customers globally Onboarding is our first shot at delight ? and we dont take that lightly, Were looking for an Onboarding Specialist who can turn new users into power users ? fast, This isnt a hand-holding role Its about educating, enabling, and empowering customers to get real value from Day 1, If youve owned onboarding journeys, improved time-to-value, or helped drive early adoption ? lets talk, ??? What Youll Own First 30 Days Run fast-paced, value-driven onboarding calls Setup ? Activation ? First win, Personalised Journe...

SSUA I, Bangalore, Office based ICON plc is a world-leading healthcare intelligence and clinical research organization Were proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development, We are currently seeking a Study Start Up Associate I to join our diverse and dynamic team As a Study Start Up Associate I at ICON, you will play a pivotal role in facilitating the initiation of clinical trials, ensuring compliance with regulatory requirements, and contributing to the advancement of inNvative treatments and therapies, What You Will Be Doing Assisting in the preparation and submission of reg...

The responsibilities of the Clinical Research Associate at AstraZeneca involve ensuring the execution of Study Delivery processes by developing study reports tools, facilitating the study delivery system, and maintaining the system. As an expert in the field, you will be responsible for ensuring the delivery of a centrally managed study management service across clinical studies from start-up to reporting. Your role will also involve serving as the main contact and collaborating closely with the Document Management group until the Clinical Study Report is finalized. In addition, you will be responsible for initiating and maintaining the production of study documents, ensuring template and ve...