Senior Medical Writer

6+ years

Preffered by Company

Remote

10 Sept. 3, 2024

Job Description

Job Type: Full Time Education: B.Pharm/ M.Pharm/ B.Sc/ M.Sc/ Any LifeScience 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

Position: Senior Medical Writer

Role Overview:

As a Senior Medical Writer, you will play a key role in creating, researching, and editing a wide range of documents related to clinical research. In this position, you may serve as the project lead writer and submission coordinator, managing the contributions of multiple writers and acting as the primary point of contact for clients. You will also drive process improvements, provide technical mentoring and training, and support Medical Writing Services management with client liaison and proposal development.

Key Responsibilities:

Document Creation and Editing: Research, write, and edit clinical research documents, including protocols, clinical study reports, investigator’s brochures, informed consent forms, and summary documents.
Project Leadership: Lead projects as the primary writer and submission coordinator, overseeing the work of multiple writers on related documents.
Client Liaison: Serve as the main contact for clients, managing communications and ensuring alignment with client needs and expectations.
Process Improvement: Facilitate improvements in writing processes and provide technical mentoring and training to team members.
Sales Support: Assist Medical Writing Services management during the sales process by contributing to client liaison and proposal development.

Qualifications:

Experience: Minimum of 6 years of experience in regulatory medical writing, with a proven track record in authoring key clinical documents.
Therapeutic Areas: Experience across multiple therapeutic areas, such as vaccines, immunology, autoimmune disorders, cardiovascular disorders, endocrine disorders, gastrointestinal disorders, infectious diseases, mental health, neurology, and oncology.
Education: Bachelor’s or advanced degree (or equivalent) in life sciences or healthcare.
Industry Experience: Background in the pharmaceutical or Contract Research Organization (CRO) industry.
Skills:
- Strong communication and interpersonal skills.
- Ability to work independently and lead projects.
- Excellent analytical skills with a keen attention to detail.
- Proven ability to manage a variable workload while maintaining high-quality outputs.

Why Join Us?

This role offers an opportunity to impact clinical research documentation at a senior level, with the chance to lead projects, mentor team members, and engage directly with clients. If you’re a dedicated professional with a passion for high-quality medical writing and process improvement, we encourage you to apply.

Ready to Make an Impact?

Apply now to join our team and contribute to advancing clinical research through exceptional medical writing.

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Senior Medical Writer

Job Description

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