Senior Clinical Documentation Specialist

3 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatoryWriter Full time
Job Description:

We are seeking a skilled Medical Writer to join our team. As a Medical Writer, you will be responsible for creating high-quality clinical and safety documents that meet regulatory requirements.

  • You will author and review CSR, DSUR, RMP documents.
  • You will lead outsourced Narrative projects and coordinate other outsourced activities in RWS.
  • You will participate in Safety Management Team (SMT) and Clinical Trial Team (CTT).

Key Performance Indicators:

Delivery of high quality clinical and safety documents in time and in compliance with internal and external standards -Customer / partner/ project feedback and satisfaction -Adherence to policy and guidelines

Responsibilities:

To ensure the success of this role, we require the following skills and qualifications:

  • Minimum 3-5 years of medical writing experience or 1-3 years of experience with MBBS/PhD.
  • Good knowledge of 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.

Benefits:

This role offers:

  • A dynamic and supportive work environment.
  • Opportunities for growth and development.
  • A competitive compensation package.

About Us:

We are a leading organization in the pharmaceutical industry, dedicated to delivering innovative solutions that improve patient outcomes. We value teamwork, innovation, and customer satisfaction.

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