Company : REV Clinical (formerly CBCC Global Research)

Position : Senior Regulatory Medical Writer

Location : Remote (India)

Website : www.revclinical.com

COMPANY BACKGROUND

REV Clinical (formerly CBCC Global Research), headquartered in Bakersfield, California with additional operations in Ahmedabad, India, is a leading, multi-national clinical contract research organization with deep experience in designing and managing clinical trials across a range of therapeutic areas, including Oncology, CNS, and Ophthalmology. REV Clinical provides end-to-end CRO services — spanning clinical study design, project management, data analysis, regulatory strategy and medical writing — across Phase I–IV clinical trials for leading biopharmaceutical companies.

ROLE: Senior Regulatory Medical Writer

We are looking for a Senior Regulatory Medical Writer with 8–10 years of experience to independently manage regulatory writing deliverables and serve as the primary scientific writing point of contact for sponsor/client accounts. The ideal candidate will have strong hands-on experience across IND submissions, regulatory meeting preparation, orphan/expedited designations, CTD Module 2 authoring, and protocol development, with therapeutic depth in oncology, ophthalmology, and neuropsychiatry.

KEY RESPONSIBILITIES

Regulatory Writing Leadership & Client Ownership

- Independently lead and manage end-to-end regulatory writing deliverables for multiple clients, acting as the primary writing contact for assigned accounts
- Manage client communications independently, including scoping writing timelines, addressing scientific queries, and presenting document strategies

IND & Regulatory Meeting Support

- Prepare and compile IND applications in accordance with US FDA requirements
- Lead Pre-IND (PIND) meeting strategy and preparation, including briefing documents, meeting requests, and agency query responses

Expedited & Orphan Pathway Documentation





- Independently develop Orphan Drug Designation (ODD) and Fast Track Designation (FTD) applications, including clinical narratives and supporting justifications
- Prepare initial Pediatric Study Plans (iPSP) and related pediatric development documentation in line with applicable regulatory requirements

CTD & Submission Authoring

- Author CTD Module 2 summaries (e.g., clinical and nonclinical overview, clinical and nonclinical summaries) supporting regulatory submissions for 505(b)(2) and 505(b)(1) pathways

Protocol & Clinical Document Authoring

- Author and finalize clinical study protocols, protocol amendments, and concept sheets for Phase I–III trials, particularly in oncology, ophthalmology, and neuropsychiatry indications
- Draft Investigator's Brochures, informed consent documents, and other regulatory/clinical documents as needed

Cross-Functional Collaboration & Compliance

- Serve as a scientific liaison between clients, regulatory affairs, clinical operations, and biostatistics teams to ensure document accuracy and alignment with study objectives
- Ensure compliance with ICH-GCP and applicable global regulatory guidelines (FDA, EMA) throughout the document lifecycle

Mentorship

- Mentor junior writers and review their deliverables for scientific and regulatory accuracy

QUALIFICATIONS

- 8–10 years of progressive regulatory medical writing experience within pharmaceutical, biotech, or CRO environments
- Demonstrated experience independently authoring IND applications in accordance with US FDA requirements




- Hands-on experience leading Pre-IND meeting strategy, briefing document preparation, and agency query responses
- Proven experience independently developing Orphan Drug Designation (ODD) and Rapid Track Designation (FTD) applications
- Experience preparing initial Pediatric Study Plans (iPSP) and related pediatric development documentation
- Strong expertise authoring CTD Module 2 summaries supporting 505(b)(2) and 505(b)(1) submission pathways
- Demonstrated authorship of clinical study protocols, protocol amendments, and concept sheets for Phase I–III trials
- Therapeutic depth in oncology, ophthalmology, and neuropsychiatry
- Comprehensive knowledge of ICH-GCP and applicable FDA/EMA regulatory guidelines
- Proven ability to independently manage client accounts, timelines, and scientific communications

ADDITIONAL ADVANTAGE

- Experience with Indian regulatory submissions, including Global Clinical Trials (GCT), patient-based Bioequivalence (BE) studies for export purposes, and IND submissions to CDSCO

SKILLS/ABILITIES

- Exceptional scientific and regulatory writing skills, with the ability to translate complex clinical and nonclinical data into clear, submission-ready documentation
- Strong client-facing communication and relationship-management skills
- Ability to independently manage multiple concurrent writing projects and competing deadlines
- Sound judgment in navigating regulatory strategy discussions with clients and cross-functional teams
- Ability to mentor and review the work of junior writers for scientific accuracy and regulatory compliance
- Strong attention to detail and commitment to quality across all document types
- Adaptable and responsive to evolving client and regulatory requirements

COMPENSATION An attractive compensation package comprised of a base, bonus and equity structure commensurate with this senior-level role will be provided.

📌 Senior Regulatory Medical Writer (USFDA) (India)
🏢 REV Clinical, Previously CBCC Global Research
📍 India