Associate Medical Writer (Remote)

0-1 years

Not Disclosed

10 April 12, 2024

Job Description

Job Type: Full Time Education: Any Graduate Skills: Causality Assessment, Communication Skills, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Technical Skill, Triage of ICSRs, WHO DD Coding

Job summary:

To support authoring, QC and associated activities for regulatory & other medical writing deliverables under guidance of Sr Medical Writer as per high-quality standards (internal & external) and within expected timelines. Support other writers for literature search, manuscripts, slide sets, abstracts, posters, other documents as needed.

Key activities:

Lear and support authoring & QC of patient narratives, CSRs, Protocol, IB, & other regulatory submission documents (excluding CTD modules) for US FDA, EMEA and rest of the world under the guidance of Sr MW. Additionally, contribute to literature search summaries, manuscripts, abstracts, posters, other techno-commercial documents as needed.
Author deliverables with scientific accuracy, based on facts from available sources and meeting quality standards (including grammar and editorial requirements).
Follow all internal and client processes and adhere to various ICH / regulatory guidelines and other industry best practices.
Undertake quality control (QC, scientific reviews and/or proofreading of the above-mentioned deliverables.
Showcase flexibility in terms of timelines and writing style based on client needs and/or therapeutic area requirements across various domains.
Support audit readiness of the department overall. Contribute to learning and development initiatives in various capacities.

Qualifications:

Education: PharmD, Mpharm, PhD, Life science/medical/para-medical Post graduates.

Experience:

No prior work experience is expected but various internship or project-based work contribution to corporate pharma or research organization will be a plus.
Candidates having post degree exposure or experience up to 1 year of experience in medical writing or flair for writing with proven academic standards are eligible to apply.
Fair understanding of industry standards and global trends. Highly proficient in MS Office products.

Work Location: It will be a fully remote position within India linked to Base Branch: Vadodara, Gujarat

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Associate Medical Writer (Remote)

Job Description

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