176 Drug Development Jobs - Page 5

The job involves following departmental Standard Operating Procedures and Work Instructions, completing required training within specified timelines, and auditing System Life Cycle (SLC) activities and documentation. You will be responsible for planning, conducting, and leading global internal facility, system, and process audits, as well as external audits of vendors and suppliers. Additionally, you will participate in client and regulatory visits as a subject matter expert in computerized systems and technology compliance. You will also be involved in authoring and reviewing controlled documents, advising internal business, IT, and QA partners on systems and technology compliance, and lead...

The increasing demand for observational research (now commonly referred to as real-world evidence [RWE]) from regulatory and reimbursement authorities has made observational research a crucial component of drug development and commercialization. Amgen's Center for Observational Research (CfOR) is a global organization with industry-leading analytical capabilities that generate RWE to support business needs across a product's lifecycle. CfOR scientists collaborate with internal stakeholders and industry experts to design, conduct, interpret, and publish observational research that informs decision-making at various stages from molecule development to clinical trial design and the safety and e...

Summary The Clinical Development Medical Director (CDMD) is the clinical leader of a section of a clinical program (e.g., an indication, a new formulation, or a specific development phase), or a large, complex trial, under the leadership of the (Sr.) GPCH. About The Role Your responsibilities include, but are not limited to: Provide clinical leadership and medical strategic input for deliverables in the assigned project/program. Deliverables may include sections of individual protocols consistent with the IDP, data review, program specific standards, clinical components of regulatory documents/registration dossiers, and publications (e.g., IBs, Brochures, briefing books, safety updates, subm...

We are seeking a talented individual to join us as a Study Designer and Edit Check Programmer within the Clinical Systems and Analytical Reporting ( CSAR ) team. This role is a crucial blend of technical expertise and leadership, where you'll build and program studies in our clinical trial database while ensuring compliance with Amgen's standards and procedures. You will act as a strong leader, influencing stakeholders and collaborating with cross-functional teams to deliver high-quality, seamless deliverables related to electronic data capture technology. Roles & Responsibilities Study Design & Programming: You will build and program studies in the clinical trial database, adhering to Amgen...

As a Manager in GCS Business Technology Solutions at AstraZeneca, you will play a crucial role in leading and innovating in the realm of Biopharma Clinical Operations. Your primary responsibility will be to design, develop, and continuously improve processes, systems, and services that drive clinical study delivery. You will collaborate with internal and external stakeholders to meet customer needs and enhance the efficiency of clinical studies. Utilizing tools like Lean Six Sigma, you will identify and implement improvements to ensure optimal end-to-end delivery. Are you ready to make a difference in this dynamic and challenging role Your key accountabilities will include designing, develop...

At ZS, passion changes lives. ZS is a management consulting and technology firm dedicated to enhancing lives and how we lead them. The company's most valuable asset is its people. Working at ZS means collaborating with a dynamic group of thinkers and experts who are developing groundbreaking solutions for patients, caregivers, and consumers globally. ZSers make an impact by adopting a client-first approach to every project. Through collaborative partnerships with clients, ZS creates tailored solutions and technology products that drive value and deliver tangible results in key areas of their operations. If you bring a thirst for learning, innovative ideas, courage, and a drive to make a sign...

You will be responsible for the CMC regulatory activities in the late phase development and/or commercial lifecycle management of GSK products. Your key duties will include overseeing global CMC regulatory activities for assigned projects, developing CMC strategy for submission documents, ensuring regulatory compliance, and participating in cross-functional project teams to define proper regulatory CMC filing strategy. Additionally, you will be expected to maintain high-quality standards, seek continuous improvement, share best practices within the CMC Regulatory teams, and engage in CMC Subject Matter Expert activities. To excel in this role, you should have a minimum level of job-related e...

As a Production Associate at Piramal Pharma Solutions (PPS), you will be part of a dynamic team within a Contract Development and Manufacturing Organization (CDMO) that offers end-to-end solutions across the drug life cycle. Your role will involve contributing to the development and manufacturing processes to ensure the delivery of high-quality pharmaceutical products. In this position, you will work at Piramal Enterprises Limited, located at Plot # 67-70, Sector II, Dhar, Madhya Pradesh, 454775, IN. As a full-time employee, you will be expected to adhere to the job schedule and actively participate in the production activities. The Piramal Group, with a strong foundation of inclusive growth...

As the Vice President of Formulation Development at Symphony Formulations Pvt Ltd, you will play a crucial role in leading the formulation R&D team based in Hyderabad. Your primary responsibilities will include overseeing project management, ensuring timely delivery of product development milestones, and strategic planning to foster innovation in drug formulation processes. You will be required to manage philanthropy initiatives, collaborate with cross-functional teams, and optimize formulation strategies to achieve corporate goals. To excel in this role, you should have a strong background in philanthropy, strategic planning, and project management. Your leadership and team management skill...

As a Safety & PV Specialist I at Syneos Health, based in the Pune Office, you will play a crucial role in ensuring the safety and pharmacovigilance of our products. Your primary responsibility will be to enter information into PVG quality and tracking systems for the receipt and tracking of ICSRs. Additionally, you will assist in the processing of ICSRs according to SOPs and project-specific safety plans. In this role, you will triage ICSRs, evaluate the data for completeness and accuracy, and ensure regulatory reportability. You will enter data into the safety database, code events, medical history, concomitant medications, and tests, and compile complete narrative summaries. Your attention...

You will be responsible for leading scientific engagement with Medical Experts as the MSL Manager. In this role, you will implement clinical and educational strategies, as well as respond to unsolicited medical inquiries. Your key responsibilities will include building and maintaining scientific relationships with Medical Experts, identifying key accounts aligned with medical priorities, developing engagement plans tailored to country-specific strategies, and providing accurate scientific information in response to medical inquiries. Additionally, you will support clinical trial execution, facilitate Investigator Initiated Trial processes, act as a scientific resource for internal field team...

You will be responsible for providing highly advanced expert support and functional and technical leadership to ensure the scientific integrity and validity for clinical development, early development, and/or research projects. Your main tasks will include developing and applying biostatistics and programming methods to ensure valid conclusions, as well as providing statistical support for regulatory submissions, including planning, analysis, and reporting of clinical safety and efficacy summaries. Additionally, you may also provide statistical support to research or other R&D areas. To meet challenges in data review, big data, analytics, and reporting of clinical trial data, you may indepen...

The position of Global Medical Advisor in the Medical Affairs department at Novo Nordisk involves providing strategic and medical guidance for a portfolio of products. As a part of the APAC Medical Affairs team, you will play a crucial role in various aspects such as the PDP process, interpretation and communication of scientific data, and understanding the clinical importance of new findings related to diabetes, obesity, rare diseases, and OSCD. Your responsibilities will include acting as the PDP Secretary, driving the PDP process at the regional level, and ensuring the timely and accurate delivery of scientific medical guidance to internal and external stakeholders. You will also be respo...

You will be responsible for providing Project Portfolio reports to facilitate decision-making and prioritize the project portfolio. You will own the cross-functional project plans within the Project Management tools, ensuring proper project management and oversight by major stakeholders. This includes creating portfolio reports with necessary information such as resource forecasts and historical portfolio trends. Additionally, you will oversee and review resource forecasting for the project portfolio, maintaining accurate and up-to-date information and establishing governance processes for monitoring forecast accuracy. You will also be accountable for developing and implementing project plan...

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 wide varie...

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 wide varie...

About ValGenesis: ValGenesis is a leading digital validation platform provider for life sciences companies. The ValGenesis suite of products is utilized by 30 of the top 50 global pharmaceutical and biotech companies to achieve digital transformation, total compliance, and manufacturing excellence across their product lifecycle. About the Role: As a Junior Validation Engineer at ValGenesis, you will work as a team member in the Validation department. Your primary responsibility will be to validate all product releases. Requirements: - A BE/BS degree in Biomedical, Pharmaceutics, or a related field. - Knowledgeable about the product development life cycle. - Familiar with drug development and...

The candidate will undergo a self-financed job-oriented patent analyst training at the Indian Institute of Patent and Trademark. On successful completion of the training, they will be placed for full-time patent analysis in the pharmaceutical domain. Required Candidate profile Scientific and Analytical Thinking Eager to work in drugs and formulation Candidates must have sound knowledge about the subjects they study in Graduation

You will be responsible for leading the out-licensing efforts for the pharmaceutical pipeline of the company. As a skilled Business Development Professional, your main tasks will include identifying global partners, driving licensing strategies, leading deal negotiations, and collaborating with cross-functional teams. To excel in this role, you should possess a strong grasp of drug development, regulatory requirements such as US FDA, EMA, and intellectual property matters. Experience with licensing deals in regulated markets like the US, EU, and Japan will be highly beneficial. Your key attributes should include excellent negotiation skills, analytical capabilities, and effective stakeholder...

You will be responsible for leading the out-licensing efforts for our pharmaceutical pipeline as a skilled Business Development Professional. The location for this role is Hyderabad (Onsite) and you will report to the Head of Business Development & Portfolio. To be successful in this position, you should have at least 5-8 years of experience in pharma business development and out-licensing. Your main responsibilities will include identifying global partners, driving licensing strategies, leading deal negotiations, and collaborating with cross-functional teams. It is essential to have a strong understanding of drug development, regulatory processes (such as US FDA, EMA), and intellectual prop...

As a Site Contracting Team Lead (SCTL) at Pfizer, you will be responsible for planning and achieving contract execution targets, managing risks to APAC targets, and collaborating with other functional lines and planners to effectively plan, prioritize, and allocate resources for studies within your remit. In this role, you will provide expertise and support to your team and other site contracting professionals, helping them independently resolve issues related to site contracting and cross-functional dependencies. Additionally, you will partner with other countries to optimize portfolio support, manage country and study level issues within your scope, and support regional site contracting ne...

You will be responsible for designing, planning, performing, interpreting, and reporting the results of scientific experiments to prepare and deliver drug substances, drug products, and processes within a multifunctional project team led by a Project Leader. You will manage technical laboratory and plant activities. As a part of the Management Track, you will lead a team in developing pharmaceutical, biological, or cell-gene therapies in a small manufacturing plant environment. You will execute the functional strategy, drive operational excellence in line with TRD vision and strategy, and ensure full portfolio support in alignment with GDD, Sandoz, NTO, and NIBR plans. In the role of an Asso...

Novo Nordisk Global Business Services (GBS) India Department Centralised Monitoring Unit, CDS GBS - Bangalore Are you passionate about what you are doingDo you want to build excellence within processes in the most efficient wayDo you have innovative mindset to drive change in a future-ready environmentAre you best at what you doIf so, raise your hand as there is an exciting opportunity waiting for you as an "Senior Functional Programmer " with us. "" At Novo Nordisk, we assure you will experience the best. About the department Bangalore Global Development since its inception, has transitioned from a small start-up to one of the largest units in Global Business Services, Bangalore (GBS) and a...

Novo Nordisk Global Business Services (GBS) India Department Centralised Monitoring Unit, CDS GBS - Bangalore Are you passionate about what you are doingDo you want to build excellence within processes in the most efficient wayDo you have innovative mindset to drive change in a future-ready environmentAre you best at what you doIf so, raise your hand as there is an exciting opportunity waiting for you as an "Functional Programmer " with us. "" At Novo Nordisk, we assure you will experience the best. About the department Bangalore Global Development since its inception, has transitioned from a small start-up to one of the largest units in Global Business Services, Bangalore (GBS) and a key co...

The Global Safety Therapeutic Areas at Amgen serve as the safety experts for all Amgen products globally. They are responsible for defining the safety strategy and major safety deliverables for each Amgen product. As a leader in the therapeutic area safety teams, you will oversee staff management and resource allocations in Global Patient Safety. Your role will involve supporting GPS in establishing a highly effective global safety organization that complies with worldwide regulations. As a Global PV Sr. Scientist, you will collaborate with the Therapeutic Safety Teams on safety assessment activities related to medical and scientific operations. Additionally, you will provide scientific and ...