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Senior Medical Writer

2-5 years
Not Disclosed
10 June 18, 2025
Job Description
Job Type: Remote Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title:

Senior Medical Writer – Remote (India)


Job Summary:

Parexel is hiring an experienced Senior Medical Writer to join its global team. This remote position requires excellent scientific communication skills, strong pharmacovigilance knowledge, and the ability to author and manage various clinical research and regulatory documents. The role offers a chance to work on innovative drug development projects and signal management activities while collaborating with international cross-functional teams.


Key Responsibilities:

  • Author signal management reports including Validations, SERs, and responses to Health Authority requests.

  • Perform end-to-end signal management: tracking, assessment, review meetings, and presentation in collaboration with GSO.

  • Conduct qualitative and quantitative signal detection from databases, literature, and regulatory sources.

  • Provide safety input across early and late-phase development activities.

  • Maintain thorough knowledge of drug safety profiles, labeling documents, global regulations, and SOPs.

  • Manage and ensure compliance with regulatory and internal timelines for adverse event reporting.

  • Author clinical narratives and contribute to post-marketing safety risk management.

  • Conduct and attend internal training; mentor new hires as needed.

  • Support benefit-risk assessments and safety-related regulatory activities.


Required Skills & Qualifications:

  • Bachelor’s or higher degree in Life Sciences, Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing.

  • Prior experience in Medical Writing, Pharmacovigilance, or Regulatory Affairs preferred.

  • Strong knowledge of medical terminology and global drug safety regulations.

  • Excellent written and verbal communication skills.

  • Proficient in MS Office Suite and web-based applications.

  • Ability to critically analyze data and summarize medical text accurately.

  • Excellent organizational, prioritization, and problem-solving skills.

  • Team-oriented with a client-focused approach.

  • Capability to manage multiple tasks with attention to detail.


Perks & Benefits:

  • Competitive compensation package.

  • Fully remote working arrangement.

  • Professional development through mentorship, training, and career advancement programs.

  • Inclusive, collaborative, and supportive work culture.

  • Opportunities to contribute to global drug development impacting patient care.


Company Description:

Parexel is a leading global clinical research organization providing comprehensive drug development and regulatory consulting services. With a strong presence in the life sciences industry, Parexel delivers tailored solutions to drive patient-centered healthcare innovations worldwide.


Work Mode:

Remote (India – including locations such as Hyderabad, Bengaluru)


Salary Range:

Not Specified (Competitive package)


Call-to-Action:

Ready to make a meaningful impact in clinical research and medical writing? Apply now to join Parexel's global team of experts and advance your career in life sciences!


Experience Required:

Relevant experience in Regulatory Affairs, Pharmacovigilance, or Medical Writing (years not specifically mentioned but prior experience is desirable).