Offer summary

Qualifications:

Minimum of 8+ years in Safety Medical Writing., At least 3-4 years of experience in authoring Signal Evaluation Reports and Health Authority responses., Degree in Life Sciences, Health, or Biomedical Sciences; medical or healthcare degrees are a plus., Proficiency in scientific writing software and familiarity with signal management principles..

Key responsibilities:

Author Signal Evaluation Reports, Health Authority responses, and ad hoc safety reports.

Ensure documents adhere to regulatory guidelines and internal standards.

Contribute to signal detection, evaluation, and interpretation of safety data.

Communicate findings effectively through written and verbal channels.

Job description

When our values align, there's no limit to what we can achieve.

At Parexel, we all share the same goal - to improve the world's health. From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us, no matter what we do at Parexel, contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally, we do it with empathy and we're committed to making a difference.

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

Required profile