Medical Writer Job at Parexel
Looking for a Medical Writer Job with a globally recognised clinical research organisation? Parexel Careers is hiring experienced professionals for a remote opportunity in India. If you’re searching for Medical Writing Jobs, this role offers the chance to contribute to global drug development by authoring clinical and regulatory documents, collaborating with cross-functional teams, and supporting innovative research programs from anywhere in India. Apply for the Remote Medical Writer Job.
About Parexel:
Parexel is a leading global Clinical Research Organisation (CRO) dedicated to improving patient outcomes by supporting pharmaceutical, biotechnology, and medical device companies throughout the drug development lifecycle. Through Parexel Careers, professionals collaborate on innovative clinical research projects while delivering high-quality regulatory and scientific documentation. With a strong focus on quality, innovation, and professional growth, Parexel offers rewarding career opportunities for experienced medical writing professionals.
Job Details:
- Job Position: Senior Medical Writer
- Company: Parexel
- Category: Medical Writing
- Job ID: R0000043704
- Location: Remote, India
- Employment Type: Full-Time
Job Description:
Parexel Careers is inviting applications for a Senior Medical Writer Job to support global drug development programs. This remote role involves authoring and reviewing clinical and regulatory documents, coordinating cross-functional reviews, ensuring compliance with international regulatory guidelines, and mentoring junior writers. Professionals seeking Medical Writing Jobs with experience in scientific writing, clinical documentation, and regulatory submissions are encouraged to apply.
Key Responsibilities:
- Author and review Study Protocols, Clinical Study Reports (CSRs), Investigator Brochures (IBs), Informed Consent Forms (ICFs), Clinical Overviews, Clinical Summaries, and Safety Reports.
- Conduct literature reviews and analyse scientific and clinical data.
- Ensure documentation complies with ICH-GCP, FDA, EMA, SOPs, and regulatory requirements.
- Coordinate document reviews and manage project timelines.
- Serve as the Medical Writing representative for assigned projects.
- Review statistical outputs and ensure accurate clinical data presentation.
- Perform quality reviews for publishing readiness.
- Mentor junior medical writers and support process improvement initiatives.
- Collaborate with cross-functional global teams.
Educational Requirements for this Remote Medical Writer Job:
Candidates applying for this job should possess:
Essential Qualification
- MD
Experience
- Experience in Medical Writing within a CRO, pharmaceutical, or biotechnology organisation.
- Strong expertise in clinical and regulatory documentation.
Skills Required for this Remote Medical Writer Job:
- Medical Writing
- Scientific Writing
- Regulatory Writing
- Clinical Documentation
- Clinical Study Reports (CSR)
- Study Protocol Development
- Investigator Brochures
- Clinical Overviews
- ICH-GCP
- FDA & EMA Guidelines
- Microsoft Word & Excel
- Document Management Systems
