Apply Online for Medical Writer at Syngene

Syngene is seeking a seasoned professional to manage its GCP quality function at THSTI Faridabad, Haryana on behalf of Syngene GCP Quality Organisation. He/she is responsible for building and scaling Quality Management Systems implementation programs and developing Quality assurance systems and implement QA oversight for clinical First-In Human (FIH) / Phase I studies and related activities. This QA Manager role is pivotal in quality and compliance oversight on clinical operations at the THSTI clinical research facility with the latest skills and knowledge to meet evolving client expectations and national and international regulatory standards and requirements.

Post : Medical Writer

Key Responsibilities
• Independently develops and finalize clinical and scientific documents such as (but not limited to) synopses, protocols, investigator brochures, CSRs, ICDs, relevant regulatory documents and clinical documents, eCTD modules, scientific communication documents such as abstracts, posters, presentations, and manuscripts etc covering various therapeutic areas and all phases of clinical research.
• Performs literature search/review as necessary to obtain background information for developing scientific content.
• Collaborates with internal and external clients to support and enable effective communication resulting in operational excellence.
• Effectively manages medical writing and review processes to deliver quality projects in agreed timelines.
• Ensure compliance to applicable regulatory guidelines, department SOPs, client style guides, conventions as applicable.
• Collaborates with clinicians, clinical scientists, and biostatisticians to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents.
• Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TLFs and other information sources.
• Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations.
• Creates and maintains SOPs and work instructions for preparation and maintenance of compliant medical/scientific writing deliverables.
• Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables and responds to findings.
• Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity.
• Review of drafts including content review, QC, and editing of drafts and final documents prepared by other/junior team members before sharing with internal and external client.
• Guide and mentor junior team members by providing appropriate trainings.
• Follow any other instructions and perform any other related duties, as assigned by the supervisor.

Safety
• Overall adherence to safe practices and procedures of oneself and the teams aligned.
• Contributing to development of procedures, practices and systems that ensure safe operations and compliance with the company’s integrity & quality standards.
• Ensuring safety of self and teams by adhering to safety protocols and following environment, health, and safety (EHSS) requirements in the workplace.
• Ensure all assigned mandatory training related to data integrity, health, and safety measures are completed on time.
• Compliance with Syngene’ s quality standards always.
• Hold self-accountable for the achievement of safety goals Govern.
• Driving a corporate culture that promotes environment, health, and safety (EHSS) mindset and operational discipline at the workplace at all times.

Additional Information
Division : Discovery Services
Location : Semicon Park, Electronic city phase II
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 30th November 2026