42 Clinical Pharmacology Jobs

Job Description ob Post: Pharmacologist Manipal Hospitals, Kharadi, Pune Department: Medical Services Manipal Hospitals, Kharadi, Pune seeks a Pharmacologist to optimize drug therapy and ensure patient safety. Mandatory Skills Pharmacology, Clinical Pharmacology, Drug Safety, pharmacy, healthcare Location Pune Roles & Responsibilities Responsibilities: Provide expert consultation on drug use. Develop drug protocols. Conduct pharmacokinetic/dynamic studies. Monitor drug effectiveness/safety. Provide pharmacology education. Conduct drug research. Collaborate with pharmacy. Participate in relevant committees. Stay updated on pharmacology. Qualifications: D Pharma 3+ years hospital experience. Strong knowledge of clinical pharmacology, pharmacokinetics, and pharmacodynamics. Excellent communication and problem-solving skills. Ability to work in a multidisciplinary team. Commitment to patient safety and quality care. Research/publication experience desirable.

LCCI Quality Medical Reviewer Medical Affairs Quality (Title/level may vary by site or geographic location) Purpose: Organization Background Scientific data and information are core assets of Lilly. Providing balanced, objective, and accurate information to regulators, the scientific community, healthcare professionals (HCPs), payers, and patients in a consistent and timely fashion across the entire drug development lifecycle is fundamental to Lilly. As HCPs are deluged with data and are making choices in an increasingly complex and stressed health system, Lilly Medical Affairs (MA) can provide clear, credible answers that will set Lilly apart from its competitors. MA s mission is to make Lilly the preferred pharmaceutical partner in the healthcare community globally by leveraging its medical expertise to drive patient-centric answers and solutions. MA brings deep medical expertise to HCPs and payers and focuses on answering HCP questions with customized clinical and real-world evidence that can make the difference on if and how they use Lilly products. Additionally, MA brings clinical insights from customers back to Lilly to inform new product development and lifecycle planning. MA also supports patients with educational tools to help them manage their illness and with assistance to access our medicines for those facing tough financial situations. Position Description The purpose of the Quality Medical Reviewer role in Medical Affairs is to review and approve U.S. medical (non-promotional) and promotional materials to ensure they are medically accurate and interpreted correctly based on the review of references/citations and data available. The Quality Medical Reviewer is expected to provide scientific and clinical inputs while collaborating with cross-functional teams during the review and approval of content, including attending review meetings. The Quality Medical Reviewer should also be aware of and ensure that all tasks are in compliance with Lilly s policies, procedures, SOPs and guidelines, and leverage different content, project, and quality management tools to increase speed and efficiency in the review and approval of promotional and medical (non-promotional) materials. Primary Responsibilities: This job description intends to provide a general overview of the job requirements at the time it was prepared. The job requirements of any position may change over time and may include additional responsibilities not specifically described in the job description. Consult with your supervisor regarding your actual job responsibilities and any related duties that may be required for the position. Know Lilly s policies and procedures, and review promotional and medical (non-promotional) materials Thorough understanding of Lilly s quality requirements and processes (i.e., CIQ and MCA requirements) and applying these guidelines consistently during the review process Verify all data values match the source documentation such as references provided, and are also consistently used throughout the document sections, charts, legends, and footnotes Verify visual representations of data accurately convey the meaning/results of the data Ensure data represents current knowledge and published scientific data Ensure information is presented in a clear, complete, accurate, and concise manner Ensure key data, statements, and conclusions are consistent across related documents, and statements and conclusions are integrated, accurate, balanced and supported by appropriate data Collaborate with cross-functional teams such as Marketing, Medical teams, etc. during the review, approval, and management of content, including attending review meetings as and when required Demonstrate working knowledge of therapeutic areas, products and disease state information, and familiarity with trial designs, rationale, and data Understand key priorities and communication strategies across therapeutic areas and/or organizational units Expertise in tools and platforms such as Veeva Vault, project planning software (e.g., Wrike, MS Project), etc. Ensure quality, speed, value, and compliance throughout the review process Understand and actively address questions related to clinical/medical/scientific content from cross-functional teams in a timely fashion Participate in the development and review of promotional and medical content in collaboration with brand teams, regulatory, copyeditors, etc. Responsible and accountable for the oversight and delivery of tasks Upholding Lilly procedures and processes Reviewing and approving materials in a timely manner Determining corrective actions to eliminate recurring issues Liaising with CIQ/MCA Lead and Operations teams in tracking and managing deviations Partner effectively with cross-functional colleagues and facilitate shared-learning forums to establish best practices and identify challenges across teams Offer scientific and medical input, and contribute to the development, review and approval of promotional and medical materials Adhere to best practices based on Lilly s internal standards Minimum Qualification Requirements: 2-4 years of experience working as a scientific/medical editor, copywriter, copyeditor, promotional and medical (non-promotional) content for publishing, marketing, communications, advertising agency, or pharmaceutical industry Must have a good understanding of scientific/medical/statistical terminologies Demonstrated initiative and ability to influence, collaborate, and work on cross-functional teams and ability to make decisions within scope of responsibility Demonstrated ability to prioritize and handle multiple concurrent tasks with strong attention to detail, critical thinking, and analytical ability Excellent written and verbal communication skills Ability to work well independently or as part of a team, within and across culturally and geographically diverse environments Experience working in a regulated industry (e.g., pharma) Additional Preferences In-depth familiarity with the US CIQ/MCA framework, procedures, processes, and tools like Veeva Vault, Wrike, etc. Experience in reviewing/writing Medical Affairs communications (slide decks, patient or HCP materials, etc.) Knowledge and experience specific to clinical pharmacology, therapeutic areas such as neuroscience, oncology, cardiovascular, immunology or endocrinology, or other medical and scientific fields Educational Requirements: Bachelor s or Master s degree in scientific, health, communications, technology health-related fields with formal research component Other Information/Additional Preferences: Location: LCCI, Bangalore Job Description Version History: Version Number Description of Change 1.0 This is the initial release. . .

Clin Infotech is offering the internship opportunity for BDS MDS Dental Graduates Should have Knowledge in Pharmacovigilance Should Have knowledge on Argus & MEDDRA Applicants Should Complete Certification in Pharmacovigilance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

Clin Infotech is offering internship Opportunities for B.Pharm and M.Pharm Freshers who are willing to start a career in Clinical Research Pharmacovigilance clinical data management sas Medical writing and Medical coding Required Candidate profile Clinical Research Internship includes of Hands on Experience on softwares in Clinical Research Pharmacovigilance clinical data management Domain. B.Pharm M.Pharm and Pharm D Are Eligible to Apply

We are currently hiring for DSA I role with a minimum of 1 year experience in Pharmacovigilance Perform triage & intake of ICSR received daily in ARGUS databases. Ensure data entry of ICSR in ARGUS Required Candidate profile A minimum of 1 year pharmacovigilance case processing experience. Responsible for coding events using MEDDRA Any Life Sciences(B pharm/M Pharm/ Pharm D, Life Sciences, Nursing, BDS, BPT) are Eligible

Perform triage & intake of ICSR received daily in ARGUS databases Should have hands On Experience On ARGUS Safety Database Should Have hands on Experience on MEDDRA Applicants Should Complete Certification in Pharmacoviiglance Required Candidate profile B.Pharm / M.Pharm/Pharm D/Life sciences degree With Hands On Experience On Argus Safety Database and Med DRA coding, Argus, Narrative Writing, Triage

Perform triage & intake of ICSR received daily in ARGUS databases within the agreed timelines Processing literature, spontaneous clinical trial and solicited cases Responsible for coding events, indications and patient history based on MEDDRA Required Candidate profile EDUCATION: M.Pharm/Pharm D/Life sciences / Microbiology / Biotech /Biochem /Nursing / BDS EXPERIENCE: Strong Knowledge in pharmacovigilance With Certification or its equivalent.

Medical Writer / Technical Content Writer - Internship This internship is ideal for someone passionate about simplifying medical or technical information into clear, structured documents and engaging content. Good Knowledge of Medical terminology. Required Candidate profile Preparation of protocol for Clinical trials Preparation writing CSR (Clinical Study Report) BDS and MBBS With medical writing for clinical trials Knowledge are Applicable

Leadership & Strategy Provide leadership and direction for all pharmacy services and staff. Develop and implement departmental goals aligned with organizational strategy. Promote a culture of safety, excellence, and continuous improvement. Clinical Governance & Compliance Ensure adherence to national and institutional regulations (e.g., FDA, MHRA, GPhC, NABH). Oversee medication safety, formulary management, and pharmacovigilance programs. Lead audits, quality assurance initiatives, and risk mitigation strategies. Operational Management Oversee procurement, inventory, and distribution of medications. Optimize pharmacy workflows, staffing, and use of technology. Ensure availability of essential drugs and rational drug use. Financial & Resource Management Develop and manage department budgets. Monitor drug expenditure and implement cost-control measures. Lead contract negotiations with suppliers and vendors. Education & Research (if in an academic or teaching hospital setting) Supervise and mentor pharmacy staff, students, and residents. Oversee continuing education and professional development programs. Facilitate academic teaching, curriculum development, and research initiatives. Collaboration & Communication Liaise with clinicians, nursing, and administrative departments to ensure integrated care. Serve as the departments representative in institutional committees and external bodies. Engage patients and stakeholders in medication-related education and decisions.

As a Medical Writer at Novartis Healthcare Private Limited, you will be responsible for writing, reviewing, and managing the production of high-quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. Your role will also involve providing authoritative documentation-related consultancy to other line functions and coaching, mentoring, and training less experienced writers. In this position, you will author, review, and independently manage complex Clinical Study Reports (CSR), Risk Management Plans (RMP), and other documents for health authorities. You will lead writing teams for complex submissions, contribute to key messaging and pooling strategy, and ensure compliance of documentation to internal company standards and external regulatory guidelines. Additionally, you will be an ad-hoc member of Clinical Trial Team (CTT) and extended member of Safety Management Team (SMT). You will provide input into planning data analyses, ensure compliance to internal company standards and external regulatory guidelines, and lead process improvement in cross-functional initiatives. Key performance indicators for this role include delivering high-quality clinical and safety documents in a timely manner and in compliance with internal and external standards, as well as completing an adequate volume of work per year according to Key Performance Indicators. To be successful in this role, you should have at least 6 years of medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge. Expert knowledge of the global regulatory environment, excellent communication skills, and the ability to prioritize and manage multiple demands and projects are essential. You should also have proven experience in managing global, cross-functional teams or complex global projects and the ability to motivate and coach people. At Novartis, we are committed to creating a brighter future by helping people with diseases and their families. We believe in collaborating, supporting, and inspiring each other to achieve breakthroughs that change patients" lives. Join our Novartis Network to stay connected and learn about suitable career opportunities as soon as they arise. If you require any reasonable accommodation due to a medical condition or disability during the recruitment process, please contact us at [email protected] Novartis is dedicated to building an outstanding, inclusive work environment that reflects the diversity of the patients and communities we serve.,

As an ideal candidate for this position, you should hold a Master's degree in Pharmacy with a specialization in Pharmacology or Pharmaceutical Analysis coupled with 5-8 years of experience. Alternatively, a Ph.D. with 2-5 years of relevant experience in PK/PD Modelling and PBPK models would also be considered. Your responsibilities in this role would include developing and applying pharmacometric models to aid in drug development and regulatory submissions. You must possess a deep understanding of non-linear mixed effects modelling and be proficient in using software tools such as PBPK models, Phoenix, R, PoPK, QSP modelling, or similar platforms. Your expertise in pharmacokinetics/pharmacodynamics (PK/PD) modelling and First-in-human dose predictions will be crucial for the success of this role. Collaboration is key in this position, as you will work closely with clinical pharmacology, biostatistics, and other interdisciplinary teams to shape clinical trial designs and analyze data. Your tasks will also involve creating and executing model-based strategies to enhance dosing regimens and achieve optimal therapeutic outcomes. Ensuring the accuracy and quality of pharmacometric analyses and reports will be a significant part of your role. You will be expected to engage with regulatory agencies, preparing submission documents related to pharmacometric analyses. Staying updated on the latest advancements in pharmacometrics and integrating new methodologies and technologies as needed will be essential. Additionally, presenting your findings and strategies to project team meetings and cross-functional teams is crucial, highlighting your ability to collaborate effectively in a team environment.,

Aster Medcity is looking for Technician - Clinical Pharmacology to join our dynamic team and embark on a rewarding career journey. Conducting electrocardiogram (EKG), phonocardiogram, echocardiogram, and stress tests by using electronic equipment. Ensuring cardiology patients are comfortable by answering any questions they have about the tests. Recording the results of cardiological tests and consulting with the physician on duty to schedule any follow-up tests. Assisting physicians during non-evasive cardiological procedures by monitoring the patients heart rates and alerting the physicians to any readings outside normal ranges. Maintaining cardiological equipment and supplies with daily cleanings and adjustments. Recording supply inventory levels and restocking the supply storeroom accordingly. Troubleshooting problems with cardiological equipment and reporting any malfunctions to superiors. Staying up-to-date with cardiological developments by attending conferences and participating in research projects

Aster Medcity is looking for Technician - Clinical Pharmacology to join our dynamic team and embark on a rewarding career journey. Conducting electrocardiogram (EKG), phonocardiogram, echocardiogram, and stress tests by using electronic equipment. Ensuring cardiology patients are comfortable by answering any questions they have about the tests. Recording the results of cardiological tests and consulting with the physician on duty to schedule any follow-up tests. Assisting physicians during non-evasive cardiological procedures by monitoring the patients heart rates and alerting the physicians to any readings outside normal ranges. Maintaining cardiological equipment and supplies with daily cleanings and adjustments. Recording supply inventory levels and restocking the supply storeroom accordingly. Troubleshooting problems with cardiological equipment and reporting any malfunctions to superiors. Staying up-to-date with cardiological developments by attending conferences and participating in research projects

Aster Medcity is looking for Technician - Clinical Pharmacology to join our dynamic team and embark on a rewarding career journey. Conducting electrocardiogram (EKG), phonocardiogram, echocardiogram, and stress tests by using electronic equipment. Ensuring cardiology patients are comfortable by answering any questions they have about the tests. Recording the results of cardiological tests and consulting with the physician on duty to schedule any follow-up tests. Assisting physicians during non-evasive cardiological procedures by monitoring the patients heart rates and alerting the physicians to any readings outside normal ranges. Maintaining cardiological equipment and supplies with daily cleanings and adjustments. Recording supply inventory levels and restocking the supply storeroom accordingly. Troubleshooting problems with cardiological equipment and reporting any malfunctions to superiors. Staying up-to-date with cardiological developments by attending conferences and participating in research projects

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Job Summary: We are looking for an experienced and strategic Clinical & Therapy Development Manager to lead the planning and execution of clinical programs and drive the adoption of new therapies. This role bridges clinical evidence generation, therapy innovation, and cross-functional collaboration to support product development, regulatory approvals, and market expansion. Key Responsibilities: Design, implement, and manage clinical studies to generate evidence supporting new therapies and devices. Collaborate with physicians, key opinion leaders (KOLs), and healthcare institutions to drive therapy adoption and clinical validation. Oversee therapy training programs for internal teams, clinicians, and field staff. Develop clinical protocols, case report forms (CRFs), and patient pathway strategies. Analyze clinical data and prepare documentation for regulatory submissions and scientific publications. Act as a clinical subject matter expert (SME) for product development and market teams. Identify therapy trends and unmet clinical needs to guide innovation strategies. Support pre-launch and post-market therapy development activities across geographies. Ensure compliance with GCP, ICH guidelines, and applicable regulatory standards.

Key Responsibilities 1. Handling of Medicines Indent verification- whether correct indent done in SRIT as per the consultant clinical notes in doctors progress notes and medication chart filled by the Medical Officer. Receivable verification-Physical verification of all medicines received on floor from OP/IP pharmacy. Administration verification- Whether drug indented is administered to the patient in timely manner as per the mentioned dosage. Bedside physical verification for the same. Thorough checking of Expiry date for all medicines on floor including crash cart medicines. Segregation of expired medicines and sending them back to the pharmacy. Ensure NABH standards for medication prescription/indent/dispense/administration/documentation at all levels. Coordination with purchase department regarding availability of alternate medications if any specific brand is not available on floor. Coordinating with doctors about any queries regarding changes or substitute medicines from the patients prescription and taking their approval. Conducting prescription audit based on the parameters mentioned as per the guidelines. Preparing indent on the basis of shortage list and frequently prescribed medicines. Daily audit of high value medicines (chemotherapy drugs/antibiotics/albumin) in all wards and critical areas. Capacity building of nursing staff and Medical Officers regarding proper documentation in medicine chart. 2. Record Keeping Maintaining temperature register of fridge and making entries thrice a day after checking the same Maintaining incident reports, with RCA and CAPA of individual report and timely escalation of the same. Data of medication error with RCA and CAPA maintained in both hard copy and soft copy. Data of high value medication administration (chemotherapy/antibiotics). ADR reporting in timely manner.

To write, review and manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of To write, review and/or manage the production of high quality clinical and safety documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative documentation-related consultancy to other line functions. To coach/mentor and/or train less experienced writers. Major accountabilities: To author, review and/or independently manage high quality clinical and safety documents: complex Clinical Study Reports (CSR), Risk Management Plans (RMP), complex CTD submission documents (clinical overviews, summaries of clinical efficacy and safety, summaries of clinical pharmacology and biopharmaceutics), other documents for health authorities (e. g. , Briefing Books, answers to questions). Lead writing team for complex submissions, actively contributing to key messaging and pooling strategy, providing expert content guidance for clinical portions of the CTD, and ensuring compliance of documentation to internal company standards and external regulatory guidelines. Ad-hoc member of Clinical Trial Team (CTT) / extended member of Safety Management Team (SMT). Core member of multiple Clinical Submission Teams (CST). Extended member of Global Clinical Teams (GCT). Input into planning of data analyses and presentation (statistical analysis plan review and meetings) used in CSRs, submission documents and/or answers to questions. Documentation expert in GCTs and CSTs to ensure compliance to internal company standards and external regulatory guidelines. Provide content and strategic expertise for clinical portions of the CTD. Program Writer for large and/or complex programs ensuring adequate medical writing resources are available for assigned program and consistency between documents. Lead process improvement in RWS and cross-functional initiatives and/or activities. Can identify training needs to foster high level of performance within RWS. Coach and/or mentor less experienced writers. Leader in cross-functional communication to optimize feedback and input towards high quality documents. Maintain audit, SOP and training compliance. Key performance indicators: Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards, according to RWS metrics. Completion of an adequate volume of work (taking into account complexity) per year in accordance with the Key Performance Indicators. Work Experience: 6 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus expert knowledge of medical writing processes. Expert knowledge of and repeat experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements). Expert knowledge, extensive experience, and demonstrated record of accomplishment in global registering of drugs. Excellent communication skills (written, verbal, presentations) Expert knowledge of biostatistics principles. Proven ability to prioritize and manage multiple demands and projects. Demonstrated ability to define and solve complex problems ( Problem-solver ) Broad knowledge and future oriented perspective Proven ability to drive and manage organizational and team performance across cultures. Proven track record in matrix environment Repeat experience in managing global, cross-functional teams or complex global projects. Demonstrated ability to motivate and coach people.

The Clinical Data Coordinator (Intern/Fresher Level) plays a crucial role in ensuring the integrity and quality of clinical trial data. This position offers a valuable entry point into the field, providing hands-on experience in core data management tasks and industry best practices. Key Responsibilities: Data Entry and Verification: Meticulous data entry into electronic data capture (EDC) systems. Verify data accuracy and consistency against source documents (e.g., Case Report Forms). Learn to identify and flag potential data discrepancies. Query Generation and Resolution: Develop an understanding of data discrepancies and their underlying causes. Assist in generating data queries to clarify issues with clinical sites. Track and follow up on resolution of data queries. Database Maintenance: Participate in database lock and maintenance procedures under supervision. Assist in implementing changes or updates to the EDC system. Reports and Metrics: Learn to generate basic data cleaning reports. Gain exposure to data quality metrics and key performance indicators. Process Improvement: Actively contribute ideas to streamline data cleaning and review processes. Qualifications: Fresher Recent graduate with a degree in life sciences, statistics, computer science, health informatics, or a related field. Intern: Currently enrolled in a relevant degree program in the fields mentioned above. Exceptional attention to detail and commitment to accuracy. Basic proficiency in Microsoft Excel. Strong interest in data management and clinical research. Desired Skills: Prior experience in a healthcare or research setting. Familiarity with medical terminology. Exposure to clinical database systems (EDC). Knowledge of Good Clinical Practice (GCP) guidelines (training will be provided). What You'll Gain: In-depth understanding of clinical data flow and data cleaning processes. Proficiency in using electronic data capture (EDC) systems. Experience with data quality review and query management. Appreciation for regulatory requirements in clinical data management. Mentorship from experienced data management professionals.

The Clinical Trial Physician is responsible for providing medical input within the organization as well as to external partners and performing medical review tasks within the context of clinical trials. Furthermore, the Clinical Trial Physician is responsible for undertaking scientific/medical writing tasks within the organization. Role & responsibilities Is responsible for the development of: All study related documents that fall under the Clinical Science Department scope (e.g., Study Protocols, ICFs - in collaboration with other departments e.g., Clinical Operations, Regulatory, as required -, Pharmacy Manuals, Medical Review Plans, etc.), Scientific presentations and manuscripts, Medical training material (i.e. therapeutic area and study protocol training material) Delivers internal and external study protocol and therapeutic area training courses Provides medical expertise and consultation within the Company on key therapeutic areas of the clinical development program Provides guidance to all involved departments on the medical and scientific aspects of the assigned clinical trials/projects. Responds to medical queries from all involved parties in assigned clinical trials (e.g., CRAs, Project Managers, Clinical Operations Managers, Investigators) and collaborates with all concerned staff in maintaining an up-to-date study-specific Q&A log Is available 24/7 to respond to urgent medical/protocol related issues derived from an Investigational Site, as applicable Performs periodic medical review of the data from clinical trials according to the study-specific Medical Review Plan requirements (e.g., review of eligibility, review of efficacy and safety data). Performs real-time medical review on urgent medical and safety issues, as needed Collaborates with and provides medical input to the Data Management staff to ensure the successful development of the study-specific eCRF Attends Investigator Meetings and Conferences, as applicable Complies with the Company's Quality and Information Security Management Systems and applicable national and international legislation, including legislation for data protection and ICH GCP requirements Preferred candidate profile Required Medical Degree (MBBS, MD) Preferred: Clinical experience in the therapeutic area of the assigned study or of the Companys clinical development program - Preferred: 2 years of experience in a CRO or in the pharma industry in a relevant role (Clinical, Medical Information, Medical Affairs or PV) Key competencies Exceptional written and oral use of English In-depth knowledge of medical and drug terminology Good medical judgement and ability to make medical decisions Excellent communication skills Excellent business acumen Initiative taking and team working attitude Excellent Organizational skills Innovative thinking Excellent IT skills Deep understanding of the Clinical Development industry