GSK Hiring Specialist - Chemistry\Pharmacology\Pharma Job

GSK Hiring Specialist – Chemistry\Pharmacology\Pharma Job

GSK Chemistry, Pharmacology, and pharmacy job opening 2022. Senior Transparency Specialist job opening 2022, Senior Transparency Specialist vacancy, pharmacology job opening 2022. Candidates with master’s degree in chemistry, pharmacology, and pharmacy may apply for the job. Intrested and eligible candidates may check out all the details on the same below:

Job Title: Senior Transparency Specialist

Location: Bengaluru, India

Categories: Medical and Clinical

Req Id: 325882

Eligbility Criteria:

University Scientific Degree, Master or equivalent professional experience in chemistry, pharmacology, Pharmacy, Clinical Research

  • Need to understand the science behind the documents (protocol/results summaries/ study reports) (be able to participate in specialized scientific discussions)
  • Need to be able to acquire knowledge in an independent and fast manner (Dependable self-starter).
  • Need to be able to handle complex governance questions in a corporate setting.

Experience

  • Broad scientific/ pharmaceutical industry background with at least 3 years of experience in scientific writing, regulatory writing or publications writing.
  • Awareness of ICH-GCP guidelines and regulations governing clinical trial disclosure (FDAAA 801 Final Rule, European Clinical Trial Directive, European Clinical Trial Regulation)
  • Experience with Clinical Trial Disclosure software solution(s).
  • Experience in a Pharmaceutical company environment and specifically in a matrix organization.

Job Purpose

The purpose of the role of the Coordinator, Clinical Trial Transparency is to coordinate the delivery of activities related to clinical trial data disclosure in GSK R&D in the respective therapy area (Oncology, Specialty, Vaccines). The role is responsible to ensure consistent, timely, and complete delivery of clinical documents and data related to GSK Sponsored human subject research e.g. protocol and results in summaries, full protocols, reporting, and analysis plans and clinical study reports, and patient-level data, ensuring ethical and transparent disclosure of data in compliance with GSK Policy on Disclosure as well as external regulations in collaboration with a multidisciplinary team of experts across projects. The role will support the implementation of new processes to meet regulatory requirements related to the transparency of clinical studies and other data disclosure deliverables.

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Key Responsibilities 

  • Responsible for end-to-end delivery of disclosure documents in the area of regulated and policy-driven clinical disclosures and data sharing. Deliver on complete, consistent, and timely disclosure of documents in scope for public disclosure registries such as GSK/ViiV Study Registers, Clinicaltrials.gov, EU Clinical Trials Register, EU PAS register.
  • Coordinate/ Author disclosure documents (protocol summaries/ results summaries) and ensure review and approval of the same by the stakeholders according to defined SOPs and operational guides. Ensure timely availability of data disclosure artefacts (e.g. redacted full protocols, statistical analysis plans and clinical study reports), as required by applicable external regulations/ internal company policies.
  • Partners with clinical study team members to ensure disclosure requirements are addressed early during the process of protocol development. Reviews protocol/ concept protocol as appropriate, for compatibility with requirements of external registers.
  • Support consistent process for trial disclosure activities throughout the therapy area. Contribute to the development of procedural documentation including guidance documents and/or instructional documents. Support maintenance and improvement of processes for disclosure function according to evolving requirements.
  • Update Disclosure systems for disclosure activities planning, tracking and delivery. Ensures archival of final records in applicable systems for the posting of the documents on the required registries. Support risk management framework implementation, including risk identification, assessment and prioritization, and the definition of mitigation plans.
  • Support risk mitigation for identified business transparency risks and manage the implications of these risks on disclosure documents. Ensure compliance to organizational key performance indicators and monitor for continuous improvement in clinical data transparency and data sharing (e.g. Transparency Dashboard).
  • Contribute to the development of training material for the business, clinical support services, and service provider(s). Maintain awareness of changes in the disclosure, transparency, and data sharing landscape, including new legal, regulatory requirements and industry trends, and translate into GSK’s Clinical Trial Disclosure and Transparency processes.
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