Clinical Documentation Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatory Full time ₹ 1,04,000 - ₹ 1,30,878
Job Overview

We are seeking a skilled Regulatory Writer to join our team. The successful candidate will be responsible for authoring and reviewing high-quality clinical and safety documents, including non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), and Risk Management Plans (RMP).

As a key member of the Clinical Trial Team (CTT) and Safety Management Team (SMT), you will work closely with cross-functional teams to ensure timely delivery of final documents for publishing.

Key performance indicators include delivery of high-quality clinical and safety documents in time and compliance with internal and external standards, customer/partner/project feedback and satisfaction, and adherence to regulatory guidelines.

Responsibilities
  • Author and review high-quality clinical and safety documents: non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Risk Management Plans (RMP).
  • Lead outsourced Narrative projects, coordinate other outsourced activities in RWS.
  • Core member of Clinical Trial Team (CTT) / participate in Safety Management Team (SMT).
  • Actively participate in planning of data analyses and presentation used in CSRs.
  • Act as documentation consultant in CTTs and SMTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
  • May act as Program Writer ensuring adequate medical writing resources are available for assigned program and consistency between documents.
  • Act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
  • Support the development of RWS through participating in RWS workstreams and other related activities.
  • Contribute to development of processes within RWS. May contribute to cross-functional initiatives.
  • Fostering cross-functional communication to optimize feedback and input towards high quality documents.
  • Maintain audit, SOP and training compliance.
Requirements
  • Minimum 3-5 years of medical writing experience or 1-3 years of experience with MBBS/PhD.
  • Good knowledge of and some experience in global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
  • Knowledge of process for and some experience in global registering of drugs (simple submissions).
  • Excellent communication skills (written, verbal, presentations) Very good understanding of biostatistics principles.
  • Ability to prioritize and manage multiple demands and projects.
  • Ability to define and solve complex problems.
  • Broad knowledge and future-oriented perspective.
  • Proven track record in matrix environment.
  • Experience in contributing to global, cross-functional projects.
  • Global, cross-cultural perspective and customer orientation.
Desired Skills

Clinical Research, Clinical Trials, Detail-Oriented, Medical Writing, Regulatory Compliance, Safety

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