6,559 Pharmaceutical Project jobs in Indonesia
Remote Lead Bioinformatician - Drug Development
Posted 2 days ago
Job Viewed
Job Description
Senior Clinical Research Associate, Drug Development
Posted 6 days ago
Job Viewed
Job Description
The Senior CRA will be responsible for site selection, initiation, monitoring, and closure of clinical trial sites. You will serve as the primary point of contact between the investigative sites and the sponsor company, ensuring effective communication and timely resolution of issues. Key duties include conducting site visits to verify data accuracy, assess patient safety, and ensure compliance with Good Clinical Practice (GCP) and other applicable regulations. You will review and reconcile essential documents, manage drug accountability, and ensure adherence to protocol requirements.
Responsibilities also include identifying potential risks and developing mitigation strategies to ensure trial integrity and patient safety. You will provide training and ongoing support to site staff, fostering strong working relationships. The Senior CRA will contribute to the development of clinical trial protocols, study plans, and case report forms. You will also be involved in data analysis and interpretation, preparing reports, and ensuring all trial-related documentation is meticulously maintained.
Qualifications require a Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field; a Master's degree is advantageous. A minimum of 5-7 years of experience as a Clinical Research Associate, with demonstrated success in managing multiple complex clinical trials. Strong knowledge of GCP, ICH guidelines, and regulatory requirements in Indonesia and globally. Proven experience in site monitoring, data review, and query resolution. Excellent analytical, problem-solving, and organizational skills. Outstanding communication, interpersonal, and negotiation skills. Ability to travel to investigative sites as required. Fluency in Bahasa Indonesia and English is essential. Familiarity with electronic data capture (EDC) systems is highly desirable. This is an exceptional opportunity for a dedicated professional to contribute significantly to advancing new medicines in Padang, West Sumatra, ID .
Remote Clinical Research Scientist - Drug Development
Posted 7 days ago
Job Viewed
Job Description
Responsibilities:
- Contribute to the development of clinical trial protocols, including study design, endpoints, and statistical analysis plans.
- Oversee the operational aspects of clinical trials, ensuring adherence to Good Clinical Practice (GCP) and regulatory guidelines.
- Monitor study progress, identify potential risks, and implement mitigation strategies.
- Analyze and interpret clinical trial data, preparing reports and presentations for regulatory submissions and internal review.
- Collaborate with cross-functional teams, including biostatistics, data management, regulatory affairs, and medical affairs.
- Manage relationships with external investigators, study sites, and contract research organizations (CROs).
- Evaluate scientific literature and stay abreast of the latest advancements in relevant therapeutic areas.
- Ensure the safety and well-being of study participants throughout the trial lifecycle.
- Contribute to the preparation of Investigational New Drug (IND) applications and New Drug Applications (NDAs).
- Participate in scientific meetings and present research findings to internal and external audiences.
Qualifications:
- Ph.D. or Master's degree in a life science discipline (e.g., Pharmacology, Biology, Biochemistry, Pharmacy) or equivalent experience.
- Minimum of 5 years of experience in clinical research within the pharmaceutical or biotechnology industry.
- Proven expertise in clinical trial design, execution, and data analysis across various phases of drug development.
- Thorough understanding of GCP, ICH guidelines, and other relevant regulatory requirements.
- Demonstrated ability to work independently and manage multiple projects simultaneously in a remote setting.
- Excellent scientific writing and communication skills, with the ability to present complex data clearly.
- Strong analytical and problem-solving abilities.
- Proficiency in using clinical trial management systems and data analysis software.
- Experience in a specific therapeutic area (e.g., oncology, cardiology, infectious diseases) is a significant advantage.
- Ability to collaborate effectively with diverse teams across different geographical locations.
This is a unique opportunity for a seasoned Clinical Research Scientist to contribute to groundbreaking pharmaceutical research from the comfort of their home office, impacting patient care globally.
Senior Clinical Research Scientist - Drug Development
Posted 8 days ago
Job Viewed
Job Description
Responsibilities:
- Design and develop clinical trial protocols, ensuring scientific rigor, ethical compliance, and alignment with regulatory requirements.
- Oversee the execution of clinical trials, including site selection, investigator training, and monitoring of trial progress.
- Analyze and interpret clinical trial data, collaborating with biostatisticians to draw meaningful conclusions.
- Prepare comprehensive clinical study reports (CSRs), regulatory submissions, and scientific publications.
- Provide scientific and technical expertise to internal teams, investigators, and external partners.
- Evaluate and select potential new drug candidates for further development based on preclinical and early clinical data.
- Ensure compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), and other relevant regulatory guidelines.
- Manage relationships with contract research organizations (CROs) and other external vendors involved in clinical studies.
- Contribute to the strategic planning of drug development programs, identifying key scientific challenges and opportunities.
- Mentor junior scientists and contribute to the development of research talent within the organization.
- Stay abreast of the latest advancements in pharmaceutical research, clinical trial methodologies, and relevant therapeutic areas.
- Ph.D. or M.D. in a relevant scientific discipline (e.g., Pharmacology, Medicine, Biology, Biochemistry).
- Minimum of 8 years of experience in clinical research and drug development within the pharmaceutical or biotechnology industry.
- Proven track record in designing and executing Phase I-IV clinical trials.
- In-depth knowledge of regulatory requirements (e.g., FDA, EMA) and ICH-GCP guidelines.
- Strong understanding of biostatistics and data analysis methodologies.
- Excellent scientific writing and communication skills, with experience in preparing publications and regulatory documents.
- Demonstrated ability to critically evaluate scientific data and make informed decisions.
- Experience in a specific therapeutic area (e.g., oncology, cardiology, neurology) is highly desirable.
- Strong project management skills and ability to manage multiple complex projects.
- Ability to work effectively in a collaborative, cross-functional team environment.
- Excellent problem-solving and analytical abilities.
Senior Clinical Research Scientist - Drug Development
Posted 8 days ago
Job Viewed
Job Description
Key Responsibilities:
- Design, develop, and implement clinical trial protocols for investigational drugs.
- Provide scientific and clinical leadership throughout the drug development lifecycle.
- Oversee the execution of clinical trials, ensuring adherence to protocols and regulatory requirements.
- Analyze and interpret clinical trial data, contributing to study conclusions and reporting.
- Collaborate with biostatistics, data management, and regulatory affairs teams.
- Prepare key clinical documents, including protocols, Investigator's Brochures, and Clinical Study Reports.
- Engage with investigators, clinical sites, and key opinion leaders to ensure study success.
- Stay current with scientific literature, emerging technologies, and regulatory guidelines.
- Contribute to the strategic planning of drug development programs.
- Present scientific findings at internal meetings and external conferences.
- Ph.D. or M.D. in a relevant life science discipline (e.g., Pharmacology, Biology, Medicine).
- Minimum of 5-7 years of experience in clinical research within the pharmaceutical or biotechnology industry.
- Demonstrated experience in designing and managing Phase I-III clinical trials.
- In-depth knowledge of ICH-GCP guidelines and regulatory submission processes.
- Proven ability to critically evaluate scientific data and translate it into clinical strategies.
- Excellent written and verbal communication skills, with strong presentation abilities.
- Proficiency in managing projects remotely and collaborating effectively in a virtual team environment.
- Strong analytical and problem-solving skills.
- Experience with therapeutic areas relevant to our client's pipeline is a plus.
Lead Pharmaceutical Formulations Scientist - Drug Development
Posted 8 days ago
Job Viewed
Job Description
Key Responsibilities:
- Lead the design, development, and characterization of innovative drug formulations for various therapeutic areas.
- Oversee the selection of appropriate excipients and drug delivery technologies to achieve desired product attributes.
- Develop and execute experimental plans for pre-formulation studies, formulation screening, and optimization.
- Conduct comprehensive stability studies to assess product shelf-life and degradation pathways.
- Utilize advanced analytical techniques (e.g., HPLC, GC, dissolution testing, particle size analysis) to characterize formulations.
- Scale up laboratory formulations to pilot and manufacturing scales, troubleshooting issues as they arise.
- Collaborate closely with analytical development, process development, DMPK, and regulatory affairs teams.
- Prepare detailed technical reports, development summaries, and regulatory submission documents.
- Stay current with the latest advancements in pharmaceutical formulation science, drug delivery technologies, and regulatory guidelines.
- Mentor and guide junior scientists within the formulation team.
- Manage project timelines and resources effectively to meet development milestones.
- Contribute to the strategic planning of the drug development pipeline.
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, Chemical Engineering, or a related discipline.
- Minimum of 8 years of hands-on experience in pharmaceutical formulation development, with a strong focus on both oral and parenteral dosage forms.
- Proven expertise in developing formulations for small molecules and/or biologics.
- In-depth knowledge of drug delivery systems, excipient science, and material characterization techniques.
- Experience with various analytical instruments commonly used in pharmaceutical development.
- Strong understanding of GMP requirements and regulatory guidelines (e.g., FDA, EMA) related to drug product development.
- Excellent problem-solving, critical thinking, and experimental design skills.
- Strong written and verbal communication skills, with the ability to present complex scientific information clearly.
- Demonstrated leadership capabilities and experience mentoring scientific staff.
- Ability to work independently and manage multiple projects concurrently in a remote environment.
Remote Senior Formulation Scientist (Drug Development)
Posted 8 days ago
Job Viewed
Job Description
Key Responsibilities:
- Design and execute pre-formulation studies to understand drug substance properties.
- Develop and optimize novel formulations for various dosage forms, including solid oral dosage forms, sterile injectables, and topical preparations.
- Characterize drug product performance using a range of analytical techniques (e.g., HPLC, dissolution testing, particle size analysis).
- Conduct stability studies according to ICH guidelines and interpret the results.
- Troubleshoot formulation challenges and identify solutions to enhance drug delivery and bioavailability.
- Work closely with analytical development teams to establish and validate relevant testing methods.
- Prepare comprehensive formulation development reports and contribute to regulatory submission documents (e.g., IND, NDA).
- Stay updated with the latest advancements in formulation science, drug delivery technologies, and regulatory requirements.
- Collaborate effectively with internal teams and external partners throughout the drug development lifecycle.
- Mentor junior scientists and contribute to the scientific growth of the formulation team.
Qualifications:
- Ph.D. or Master's degree in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a related field.
- 6+ years of hands-on experience in pharmaceutical formulation development.
- Proven expertise in developing various dosage forms, with a strong understanding of excipient science and drug-delivery systems.
- Proficiency with analytical techniques commonly used in formulation and characterization.
- Thorough understanding of ICH guidelines and regulatory requirements for drug development.
- Excellent problem-solving, critical thinking, and experimental design skills.
- Strong written and verbal communication skills, essential for remote collaboration and report writing.
- Ability to work independently, manage multiple projects, and meet strict deadlines.
- Experience with biologics formulation is a significant plus.
Be The First To Know
About the latest Pharmaceutical project Jobs in Indonesia !
Clinical Trials Manager
Posted 3 days ago
Job Viewed
Job Description
Key Responsibilities:
- Develop and manage clinical trial protocols, budgets, and timelines.
- Identify, evaluate, and select clinical trial sites and investigators.
- Oversee the conduct of clinical trials in compliance with Good Clinical Practice (GCP) guidelines, ICH guidelines, and local regulations.
- Manage and mentor Clinical Research Associates (CRAs) and other study personnel.
- Ensure accurate and timely collection, cleaning, and analysis of clinical trial data.
- Liaise with regulatory authorities and ethics committees to obtain necessary approvals.
- Monitor trial progress and identify any potential risks or issues, implementing mitigation strategies.
- Manage vendor relationships, including contract research organizations (CROs) and central labs.
- Ensure study supplies, including investigational products, are managed appropriately.
- Prepare and submit regulatory documents, progress reports, and final study reports.
- Organize and conduct investigator meetings and site monitoring visits.
- Facilitate effective communication among study team members, investigators, and stakeholders.
- Manage safety reporting and pharmacovigilance activities for the trial.
- Contribute to the development of new clinical research strategies and initiatives.
- Ensure the quality and integrity of clinical trial data.
Qualifications:
- Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related field. A Master's degree or Ph.D. is preferred.
- Minimum of 6 years of experience in clinical trial management within the pharmaceutical or biotechnology industry.
- In-depth knowledge of GCP, ICH guidelines, and relevant regulatory requirements.
- Proven experience in managing multiple clinical trials simultaneously.
- Strong project management skills, including budgeting and timeline management.
- Excellent leadership, communication, and interpersonal skills.
- Experience with electronic data capture (EDC) systems and clinical trial management systems (CTMS).
- Ability to travel to clinical sites as needed.
- Experience in therapeutic areas relevant to the company's pipeline is a plus.
- Strong analytical and problem-solving skills.
- This role is based at our facility in Pekanbaru, Riau, ID and requires a dedicated on-site presence.
Clinical Trials Manager
Posted 8 days ago
Job Viewed
Job Description
Responsibilities:
- Develop and manage clinical trial protocols, budgets, and timelines in collaboration with investigators and study teams.
- Oversee the planning, initiation, and monitoring of clinical trial sites to ensure data integrity and patient safety.
- Ensure adherence to Good Clinical Practice (GCP) guidelines, FDA regulations, and other relevant international standards.
- Manage relationships with Contract Research Organizations (CROs) and other vendors involved in clinical trials.
- Coordinate the collection, management, and analysis of clinical trial data.
- Prepare and submit essential documents for Institutional Review Board (IRB) and regulatory agency approvals.
- Conduct site initiation visits, interim monitoring visits, and close-out visits.
- Identify and mitigate risks associated with clinical trial execution.
- Train and mentor clinical research associates and other study personnel.
- Prepare comprehensive clinical study reports and contribute to scientific publications.
- Maintain clear and consistent communication with internal stakeholders, investigators, and regulatory bodies.
- Manage drug supply and investigational product accountability throughout the trial.
The ideal candidate will possess a strong background in clinical research, with a proven track record of successfully managing multi-center clinical trials. Excellent leadership, organizational, and problem-solving skills are essential. This role demands a meticulous approach to detail and a deep understanding of the pharmaceutical development process. You will be expected to work collaboratively within a dedicated team and contribute to the strategic direction of our clinical research endeavors. The base in Medan, North Sumatra, ID is a vibrant hub for our research activities, and we are looking for a dedicated professional to join our mission.
Remote Lead Pharmaceutical Formulation Scientist - Drug Development
Posted 8 days ago
Job Viewed
Job Description
Responsibilities:
- Lead the design, development, and optimization of pharmaceutical formulations for various therapeutic areas.
- Develop innovative drug delivery systems to enhance efficacy and patient compliance.
- Oversee pre-formulation studies, including API characterization and excipient compatibility.
- Formulate various dosage forms, such as tablets, capsules, injections, and topical preparations.
- Design and execute stability studies to determine product shelf-life.
- Develop and validate analytical methods for formulation characterization.
- Prepare comprehensive formulation development reports and documentation for regulatory filings (IND, NDA).
- Lead and mentor a team of formulation scientists, fostering scientific rigor and innovation.
- Collaborate with CMC, DMPK, and clinical teams to advance drug candidates.
- Stay abreast of emerging trends and technologies in pharmaceutical formulation and drug delivery.
- Ph.D. in Pharmaceutical Sciences, Pharmaceutics, Chemistry, or a closely related field.
- Minimum 8-10 years of experience in pharmaceutical research and development, with a focus on formulation science.
- Demonstrated experience in leading formulation development projects and teams.
- In-depth knowledge of various dosage forms and drug delivery technologies.
- Expertise in GMP regulations and pharmaceutical development processes.
- Proficiency with relevant analytical techniques (e.g., HPLC, GC, dissolution testing).
- Strong scientific problem-solving and critical thinking skills.
- Excellent written and verbal communication abilities, with experience in technical writing.
- Proven leadership and team management capabilities.
- Ability to work effectively in a fully remote, collaborative environment.