Senior Medical Writer

6-7 years

Not Disclosed

India Remote

10 Feb. 10, 2025

Job Description

Job Type: Remote Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences 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
Location: India (Remote)
Job ID: R0000028242
Category: Medical Writing
Date Posted: 01/15/2025

Job Purpose

The Senior Medical Writer is responsible for researching, creating, and editing all documents related to clinical research. This role may serve as the project lead writer or submission coordinator, managing the contributions of multiple writers working on related documents. The Senior Medical Writer also plays a key role in process improvement, technical mentoring/training, and providing client liaison and proposal input during the sales process.

Key Responsibilities

Medical Writing and Project Leadership

Research, create, and edit clinical research documents, ensuring high quality and regulatory compliance.
Serve as the project lead writer or submission coordinator, managing the workflow and contributions of multiple writers on related documents.
Facilitate process improvements within the Medical Writing team.
Ensure all documents meet client specifications and regulatory requirements.
Lead the development of protocols, clinical study reports, investigator’s brochures, informed consent forms, and summary documents.

Client Liaison and Sales Support

Act as the primary client contact for medical writing-related projects.
Support the Medical Writing Services management during the sales process, providing client liaison and proposals input.
Communicate effectively with clients to understand their needs and deliver high-quality documents.

Mentoring and Training

Provide technical mentoring and training to less experienced writers.
Help develop and implement best practices within the medical writing team.

Skills and Qualifications

Experience

Minimum of 6 years of experience in regulatory medical writing.
Experience in authoring key clinical research documents such as protocols, clinical study reports, investigator’s brochures, informed consent forms, and summary documents.
Experience across multiple therapeutic areas, including vaccines, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, mental health, neurology, oncology, and others.

Skills

Strong written and verbal communication skills.
Strong interpersonal and team collaboration skills.
Ability to work independently and manage projects.
Exceptional analytical skills and attention to detail.
Commitment to producing high-quality outputs and meeting deadlines.
Ability to manage a variable workload effectively.

Education

Bachelor’s or advanced degree in Life Sciences, Healthcare, or related field (equivalent education/degree is also acceptable).

Additional Requirements

Experience within the pharmaceutical or Contract Research Organization (CRO) industry is preferred.

This position offers a remote working opportunity for experienced Senior Medical Writers to lead projects, contribute to process improvements, and engage with clients in the clinical research field.

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