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Senior Executive\Specialist - Technical Writing

Full-Time

Bengaluru, India

Hyderabad, India

Description

Job Responsibilities :

  • Responsible for the writing of Clinical Evaluation Plans.
  • Responsible for compliant writing of Clinical Evaluation Reports within this business in accordance with local procedures, client guidelines and regulatory requirements.
  • Responsible for ensuring compliant creation of SSR reports within this business in accordance to local procedures, client guidelines and regulatory requirements
  • Ensures the CER and SSR files are linked to appropriate Quality Systems and Regulatory documents (e.g. Risk Management, PMS, etc.) to make certain information is consistent and accessible where needed.
  • S/He will develop, implement and manage an effective communication model for CERs/SSRs with cross functional business partners
  • Assists in the development of schedules to ensure operating company CER/SSR timelines are met.
  • Participates in workshops and on initiatives to help define processes globally and keep abreast of CER regulatory requirements and industry trends/practices, ensuring that a proactive ongoing review of processes and procedures is in place to maintain a strong regulatory profile while continually improving process efficiencies
  • Supports and at times acts as an SME during audits and inspections pertaining to CER/SSR processes and reports.
  • Will actively partner with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs relating to the CER/SSR process.

Requirements

Candidate Profile :

  • Graduate or Post-graduate in Life-Sciences, with a minimum of 1-3 years of related job experience is required.
  • Experience within the medical device industry and knowledge of clinical evaluation report, regulatory requirements, evidence generation, and CER document creation is required.
  • Demonstrated knowledge and experience in quality regulatory compliance, complaint handling, adverse event reporting, medical device risk management processes, and experience with common biostatistical methods is preferred.
  • Regulatory/Notified Body audit experience is preferred.

Lead Statistical Programmer

Full-Time

Bengaluru, India

Hyderabad, India

Description

Job Responsibilities :

  • Annotate Case Report Form (acrf.pdf) following FDA/CDISC or sponsor guidelines.
  • Develop SDTM specifications and generate SDTM datasets using SAS.
  • Develop ADaM,specifications and generate ADaM datasets using SAS based on Statistical Analysis Plan.
  • Develop Tables, Listings, Graphs, Patient Profile in support of the Clinical Study Report, Posters, Manuscripts.
  • Develop ADaM data, Tables, Listings, Figures for Integrated Summary of Safety (ISS) and Integrated Summary of Efficacy (ISE).
  • Create electronic submission package to FDA, e.g., define.xml or define.pdf following FDA guidelines with minimum supervision.
  • Analyze information and develop innovative solutions to programming and data analysis challenges.
  • Actively communicate with statisticians for statistical input and analysis interpretation.
  • Follow and reinforce regulatory agency requirements during daily job.
  • Serve as a programming team lead and contribute to department initiative.
  • Provide guidance, mentoring, training for team members and help solve issues from cross-functional teams.
  • Review draft and final production deliverables for project to ensure quality and consistency.

Requirements

Candidate Profile :

  • Master’s / Bachelor’s degree in Statistics, Mathematics, Computer Science, Electrical Engineering, Biotechnology or related scientific disciplines.
  • Should have 8-13 years of experience in Statistical Programming in Clinical domain.
  • Proven knowledge and training in high level computing languages such as. SAS, C/C++, Java, R, Python, MATLAB and SQL. Database programming experience is a plus.
  • Proficient in decoding programming logic and assembling programming code based on logic provided and be able to explain to team members.
  • Proficient in applying concepts in Artificial Intelligence and Machine Learning in the real world.
  • In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Good understanding of clinical drug development process.
  • Strong communication skills and coordination skills. ability to communicate with global teams with supervision.
  • In-depth knowledge of Good Clinical Practices, Clinical research, Clinical trial process and related regulatory requirements and terminology.
  • Good understanding of clinical drug development process.
  • Detail-oriented and ability to learn and adapt to changes.
  • Proficient in Microsoft Office Suite, e.g., Word, Excel, PowerPoint, etc

 

Safety Surveillance Specialist/Physician

Full Time

Bengaluru, India

Hyderabad, India

Work Remotely, India

Description

Job Responsibilities :

  • Perform medical interpretation of safety data with client oversight.
  • Retrieve, analyze and interpret data from multiple sources (client systems, clinical trials, safety databases, literature, etc.).
  • Determine and document the impact of identified safety issues on benefit-risk profile of affected client product(s).
  • Lead authoring of assessment for identified signals as directed by client.
  • Support the preparation of presentations of safety data and related information for client leadership and safety governance committees.
  • Lead authoring of assigned sections of client Safety deliverables.
  • Lead or support the preparation of regulatory safety requests.
  • Other routine safety duties as assigned by client.
  • Signal Detection and Assessment.
  • Interpretation, summarization, and presentation of data and assigned safety deliverable documents.
  • Assigned sections of client safety deliverable documents such as DSUR,PSUR,PADER,ACO,RMP,Clinical Overview,CSS,HHA.

Requirements

Candidate Profile :

  • Candidate should be M.Pharm, BDS, MDS, MBBS, MSc in Life Sciences.
  • Should have 2-6 years of experience in Signal Management activities.
  • Strong verbal and written communication skills, with ability to communicate effectively internally and with clients.
  • Experience in Signal Detection, Signal Evaluation, and validation required.
  • Candidate should be able to work in US timezone.