Senior Medical Writer

6+ years

Not Disclosed

India

10 Jan. 21, 2025

Job Description

Job Type: Full Time Remote Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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

Senior Medical Writer
Location: India, Remote
Job ID: R0000028242
Category: Medical Writing
Date Posted: 01/15/2025

Overview

As a Senior Medical Writer at Parexel, you will leverage your scientific knowledge, writing skills, and patient-focused approach to effectively communicate complex scientific data to a variety of stakeholders, including regulatory agencies, medical professionals, and the general public. You will collaborate within cross-functional teams to develop a wide range of clinical research documents such as:

Model informed consent forms
Clinical study reports
Pharmacovigilance documents, and more.

We foster a culture of inclusivity, collaboration, and support, empowering our employees to make a meaningful impact on people's lives. We offer continuous learning opportunities, from mentorship to job shadowing, job rotation, stretch assignments, and leadership development. Your growth and promotion are guided by global standards and a personalized development plan.

Success Profile

Do you possess the following traits to succeed at Parexel?

Adaptable
Communicator
Consistent
Deadline-oriented
Detail-oriented
Insightful

About This Role

Senior Medical Writer

In this role, you will:

Research, create, and edit all documents related to clinical research.
Serve as the project lead writer/submission coordinator and primary client contact, managing the contributions of multiple writers working on related documents.
Facilitate process improvements and provide technical mentoring/training.
Support Medical Writing Services management during the sales process by providing client liaison and input on proposals.

Minimum Qualification Requirements

Experience: 6+ years in regulatory medical writing, with hands-on experience in authoring protocols, clinical study reports, investigator’s brochures, informed consent forms, summary documents, etc.
Therapeutic Areas: Experience across multiple therapeutic areas, including but not limited to vaccines, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, mental health, neurology, oncology, etc.
Education: Bachelor's or advanced degree (or equivalent) in life sciences/healthcare.
Industry Experience: Experience in the pharmaceutical/CRO industry.
Skills:
- Strong communication and interpersonal skills
- Ability to work independently and lead projects
- Strong analytical skills
- Commitment to high-quality outputs, with a keen attention to detail
- Ability to manage a variable workload

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Senior Medical Writer

Job Description

Overview

Success Profile

About This Role

Minimum Qualification Requirements

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