10 Bioequivalence Jobs

Role & responsibilities Overall responsibility of study. Conduction of study initiating meeting. ICF preparation / obtaining ICF from subject. Conducting clinical examination Review of study documents. Supervise study activities. Preparation of study reports. Communication with sponsor and IEC/IRB. To train other clinical staff. Preferred candidate profile Interested Candidate share resume on TeamHR.VAD@accutestglobal.com. Whatsapp on 9833402126

Role & responsibilities Performing as Sub-investigator in the assigned clinical studies Reviewing study documents Preparation of Clinical Raw data Protocol, SOP and various Regulatory compliance Protocol/ICF/CSR review Study initiation and Execution Pre study document preparation Dosing of the subjects Monitoring the study process Preparation of confinement report, clinical updates & clinical summary report Compilation of study documents as per protocol Review study documents and handing over to QA for review. Close the QA / Sponsors observation / queries Archival & Retrieval of study documents Subject safety follow-up Serving as QC in the assigned clinical studies Performing pharmacy activities. EC submission of protocols and related activities Preferred candidate profile Knowledge of ICH - GCP Knowledge in Regulatory guidelines like CDSCO, USFDA, EMEA, WHO etc., Communication skills

Job location: Ahmedabad Experience Required- 4+ years of experience in QA (Clinical Research) Role & responsibilities A. Review Protocol and its attachments. B. Conduct in-process and retrospective audit of clinical phase of the study to ensure compliance to protocol, SOPs and applicable regulatory requirements. C. Review Clinical report to verify that the data reported in the report, accurately reflects the raw data and to ensure that the report is prepared in compliance with SOP, ICH E3 and applicable regulatory requirements. D. Conduct system audits as per the system audit plan. E. Conduct vendor pre-qualification and re-qualification audits as per the vendor audit plan. F. Preparation, Review, distribution, maintenance, recall and destruction of QMS Documents (SOPs, Policies, WIs, Manuals, forms and Plans . ) G. Review and maintain calibration, validation and Mapping documents and Temperature data / OOS data (Eurotherm data )review. H. Issuance of logbooks. I. Review of deviations, event and change control procedures and provide number to respective document. J. Provide Instrument IDs as per SOP. K. To maintain/update study/System specific tracker/Index on on-going basis. L. Assisting Team in charge in Regulatory/Sponsor Audit. M. Maintain Master Signature Log.

Job Posting Title: Senior Principal Biostatistician Reports to (Job Title) : - Group Head Biostatistics and Pharmacometrics Job Description : The Senior Principal Biostatistician is responsible and accountable for all statistical work, scientific and operational, for one or more assigned trials in collaboration with the clinical trial team. Works independently at the trial level and may lead indication or project level statistical activities for a development project under limited supervision. Proposes and leads implementation of modern and innovative trial/experimental designs, statistical models, analysis and data exploration methodologies at the study or project level. Study level : - Key Responsibilities Study Level-Responsible for all statistical tasks on the assigned trials, and perform these tasks for mid- to high- complexity trial independently with peer review/input as required. Responsible for protocol development in alignment with the development plan, developing statistical analysis plan, reporting activities. Contribute to planning and execution of exploratory analyses, and/or PK, PK/PD analyses, exploratory biomarker and diagnostic analyses, and statistical consultation. Initiate, drive and implement novel methods and innovative trial de-signs in alignment with the Lead Statistician. Explain statistical methodology and interpret analysis results. Provide statistical expertise to support submission activities and documents, meetings with and responses to Health Authorities and other drug development activities, as required. Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Oversee all Biostatistics resources and deliverables for assigned trials. En-sure timeliness and adequate quality of all Biostatistics deliverables for the assigned trials and/or non-clinical related activities. Project level -May be a core member of an early project team for a low-complexity program and represents Biostatistics and Pharmacometrics as part of development plan with oversight. Collaborate with clinical, regulatory and other strategic functions to drive quantitative decision making in assigned indications/program with oversight. Collaborate cross-functionally (e.g. data management, programming, medical writing) to ensure timeliness and quality of statistical deliverables. Propose and implement innovative designs and methods to optimize dose finding and drug development. Contribute to planning, prioritization and tracking of program level biostatistics activities and effective partnership with vendors. Significantly contributes to project team preparation for HA Advisory Committees and meetings. Franchise or Global Line Function level: Significantly contribute to initiatives at global line function level Enterprise level - Actively contribute to cross-functional organizational / process /scientific consulting improvement initiatives. Contribute to the review and implementation of health authority guidance. Identify, evaluate, and promote the use and the acceptance within and out-side the organization, of innovative methods, through scientific collaborations, publications in scientific peer reviewed journals, presentations and chairing sessions at professional meetings. External leve l- Contribute to interactions with external review boards/ethics committees, ex-ternal consultants and other external parties with oversight as appropriate. Represent Novartis in statistical discussions at external congresses, conferences, scientific meetings. Education (desirable) : - MS (in Statistics or equivalent) with 7+ years relevant work experience or PhD (in Statistics or equivalent) with 4+ years relevant work experience. Languages : - Fluent English (oral and written) Requirement : - Influences decisions that directly impact the assigned clinical trial and team ability to deliver objectives. Proven knowledge and expertise in statistics and its application to clinical trials. Depending on the assignment, may require proven expertise in pharmacokinetics, exposure-response modelling, exploratory biomarker, diagnostic analyses, applied Bayesian statistics, or data exploration skills. Proficiency in use of statistical software packages (e.g. SAS, R). Knowledge of drug development and Health Authority guidelines. Able to work on and collaborate seamlessly with a multidisciplinary team to achieve team objectives. Experience in Franchise/Therapeutic Area and/or regulatory activities desirable.

CPC & CCS Certification Training With Placement Life sciences Graduates only in Medical Coding Freshers * Must be certified (CPC/CCS) from AAPC or AHIMA * Strong knowledge on Human Anatomy, Physiology Offline - KPHB @Hyderabad Call - 9052442000

Key Responsibilities 1. Dossier Preparation and Submission CTD/eCTD Compilation: Assemble and submit regulatory dossiers in Common Technical Document (CTD) format, including modules for clinical, non-clinical, and quality data.

Role & responsibilities: Sample collection, dosing, separation

Role & responsibilities : Work as Pharmacokinetic and Scientific Affairs Personnel. 1. Provide feasibility inputs like study design, sample size estimation, sampling time points, wash out period, etc. 2. Review, evaluation and interpretation of PK/PD data from BA/BE studies-clinical trials and suggesting appropriate inputs in protocol and clinical study report 3. Review statistical report as per requirement. 4 Prepare and review statistical/pharmacokinetic analysis plan as per requirement 5. Archive and retrieval of data 6. Maintain and update feasibility database as per requirements 7. Maintain and assist regulatory query handling and tracking. 8. Provide impact assessment of PK related protocol deviations/Con-med assessment Preferred candidate profile: M. Pharma with min.1-2 years of relevant experience as PK Scientist in Clinical research (BA/BE studies). Job Location: Ahmedabad

a. Should be well versed with IVIVC concepts b. Should have excellent knowledge on product development and clinical studies. c. Should have hands on experience on operating various simulation tools necessary for IVIVC. d. Excellent communication skills are must.

Expertise in Ba/BE studies and Ph1;Brief CRO to an appropriate conduct of statistical analysis;Supports dossier submissions and answers statistical questions related to the file. Writes/review statistical part of protocol. Required Candidate profile Manages several projects and works in more than one therapeutic area.Appropriate statistical methodology &endpoint definitions -design of clinical studies & for associated sample size determination