Job Summary
Parexel is hiring a Principal Medical Writer for a full-time remote position based in India. This senior role requires expertise in authoring Signal Evaluation Reports (SERs), Health Authority (HA) responses, and ad hoc safety reports. The successful candidate will possess over 8 years of experience in safety medical writing and at least 3-4 years specifically focused on signal evaluation and regulatory submissions. Working within cross-functional teams, you will play a critical role in interpreting complex safety data and communicating it clearly to global stakeholders, ensuring compliance with regulatory standards.
Key Responsibilities
Author high-quality Signal Evaluation Reports (SERs), Health Authority responses, and ad hoc safety documents.
Lead the preparation of a range of clinical research documents including clinical study reports, pharmacovigilance materials, and informed consent forms.
Collaborate with cross-functional teams including regulatory, safety, and clinical development teams to ensure timely and accurate document delivery.
Apply signal management principles and contribute to signal detection and evaluation processes.
Ensure all documents meet global regulatory and internal quality standards.
Utilize scientific writing software and document management tools effectively.
Maintain excellent communication with internal and external stakeholders.
Required Skills & Qualifications
Minimum 8+ years of experience in Safety Medical Writing.
At least 3-4 years of focused experience in authoring SERs, HA responses, and ad hoc reports.
Strong understanding of signal management, detection, and safety data evaluation.
Proven ability to produce scientifically sound, concise, and regulatory-compliant documents.
Proficiency with Microsoft Office Suite, EndNote, and data visualization tools.
Familiarity with document management systems is a plus.
Excellent written and verbal communication skills in English.
Educational background in Life Sciences, Medicine, Pharmacy, or related disciplines (e.g., Microbiology, Biochemistry, Biotechnology, Biophysics).
Degree in Medicine/Dentistry/Physiotherapy/Nursing with hospital-based patient exposure is advantageous.
Perks & Benefits
Fully remote position within India.
Collaborative and inclusive global work environment.
Opportunities for professional growth through mentorship, job rotation, and training.
Access to global development and career advancement programs.
Positive and supportive culture fostering innovation and scientific excellence.
Company Description
Parexel is a global leader in clinical research and regulatory consulting services, dedicated to improving patient health worldwide. Known for its scientific rigor and commitment to high-quality healthcare solutions, Parexel supports pharmaceutical and biotech companies in bringing safe and effective therapies to market.
Work Mode
Remote (India)
Call to Action
If you have a passion for scientific writing and a strong background in safety medical documentation, apply now to join Parexel's esteemed global team and contribute to life-changing healthcare advancements.
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