Principal Medical Writer

2 days ago

Delhi Delhi, India Parexel Full time

Principal Medical Writer with specialized experience in authoring Signal Evaluation Reports (SERs), Health Authority (HA) responses, and ad hoc reports, signal management process

Below are the key requirements for the role:
**Experience**:Required at least 8+ years of experience in Safety Medical Writing with minimum of 3-4 years of experience in authoring signal Evaluation Reports, Health Authority responses, and ad hoc reports is essential. Proficiency in scientific and medical writing is a must. Demonstrated ability to produce clear, concise, and accurate documents that adhere to regulatory guidelines and internal standards.

**Signal Management Expertise**: Familiarity with signal management principles and methodologies is highly desirable. Experience in signal detection, evaluation, and interpretation of safety data is a significant advantage

**Communication Skills**: Excellent communication skills, both written and verbal.

Proficient in scientific writing software (e.g., Microsoft Office Suite, EndNote) and data visualization tools. Familiarity with document management systems is advantageous.

**Education**:

- Science/Medicine degree: The minimum qualification required would be a university degree in life Sciences/ Health or Biomedical Sciences (Pharmacy, microbiology, Biochemistry, Biotechnology, Biophysics etc.)
- A degree in Medicine/Dentistry/physiotherapy/Experimental Medicine/Nursing, which involves patient exposure in hospital-based environment, would be an advantage

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