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Gi Group
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Sr. Medical Writer - Regulatory Writing

Sr. Medical Writer - Regulatory Writing

Gi Group

8 - 13 years

15 - 27 Lacs

Bengaluru

Posted:21 hours ago| Platform:

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Skills Required

CTD CSR Protocol Writing Investigator Brochure ICF Module 5 Module 2

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title:

Education Requirements:

MBBS / PhD / MDS / BDS / MPharm / PharmD/M.Sc/B.Pharma/B.Tech

Location:

Experience:

8 to12 years of experience in authoring clinical and regulatory documents supporting global filings, particularly CTD Module 2 and Module 5.

Role Purpose:

This role involves managing complex medical writing projects, reviewing regulatory deliverables, and mentoring junior writers. The position requires both strategic thinking and hands-on execution in support of global regulatory submissions.

Key Responsibilities:

Independently prepare and review regulatory documents such as clinical study reports (CSRs), protocols, investigator brochures (IBs), informed consent forms (ICFs), and CTD Modules (2.4, 2.5, 2.6, 2.7, 5.2).
Apply lean authoring and structured content principles to regulatory documents.
Coordinate cross-functional review meetings and finalize documents under tight timelines.
Develop and maintain detailed project plans and task trackers.
Drive consistency in content and messaging across document sets.
Lead and facilitate document kick-off and consensus meetings.
Mentor and manage junior writers; provide guidance on templates, standards, and expectations.
Perform literature reviews, competitive intelligence, and regulatory research as needed.
Actively contribute to departmental initiatives, process improvements, and knowledge sharing.
Ensure full compliance with training, documentation, and submission standards.

Required Skills & Competencies:

Proven experience in authoring a broad range of clinical and regulatory documents for global filings.
Strong grasp of regulatory expectations across US, EU, and other major markets.
Ability to interpret data, build scientific arguments, and align with regulatory strategy.
Expertise in managing cross-functional teams and stakeholder communications.
Excellent time management, organizational, and interpersonal skills.
Strong written communication and technical editing abilities.
Minimum 2+ years of people management or mentoring experience.
Strong customer focus and collaborative mindset.
Ability to support multiple therapeutic areas and ensure business continuity.

Technology Proficiency:

Advanced MS Word skills (styles, templates, reference tools).
Experience with document management systems and electronic review workflows.
Familiarity with structured content authoring tools and add-ins.
Adaptability to new tools, platforms, and digital collaboration environments.

Scientific & Regulatory Knowledge:

Deep understanding of the clinical development lifecycle from study design to submission.
Ability to develop regulatory content based on scientific logic, data interpretation, and therapeutic knowledge—even in the absence of direct data.
Up-to-date knowledge of global regulatory guidelines (e.g., ICH, FDA, EMA).
Skilled in aligning messaging with clinical strategy and prior submissions.
Capable of simplifying complex scientific data for regulatory communication.

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