Medical Writer

REV Clinical; United States; Teletrabalho; USD 80 000 - 120 000; Tempo integral

Resumo da oferta

REV Clinical is seeking a remote Medical Writer with 3–6 years of experience to independently prepare, review and finalize clinical and regulatory documents from concept to submission. The role collaborates with Project Management, Data Management, Biostatistics, Medical Monitoring and QA to ensure timely, high-quality outputs in line with ICH-GCP and regulatory standards.

The position offers a fully remote setup with international operations and opportunities to contribute to regulatory

Qualificações

• Degree in Life Sciences, Pharmacy, Medicine or related field; advanced degree preferred.
• 3–6 years of medical writing experience in CRO/pharma/biotech.
• Experience drafting Protocols, ICFs, IBs and concept sheets.
• Experience with Module 2 overviews and regulatory submissions.
• Knowledge of ICH-GCP and global regulatory guidelines (FDA/EMA/CDSCO).

Responsabilidades

• Act as primary contact for medical writing projects at REV Clinical.
• Independently prepare, review and finalize study documents (protocols, ICF, IB).
• Prepare regulatory materials including briefing documents and regulatory submissions.
• Develop SEC presentations and manuscripts for publications.
• Collaborate with cross-functional teams to ensure on-time delivery.

Conhecimentos

Medical writing

Regulatory writing

ICH-GCP familiarity

Scientific communication

Remote work autonomy

Formação académica

Life Sciences degree

Ferramentas

Regulatory documentation tools

Descrição da oferta de emprego

POSITION DESCRIPTION

Company

REV Clinical (formerly CBCC Global Research)

Position

Medical Writer

Experience

36 years

Location

Remote

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: Medical Writer

The Medical Writer will serve as the primary point of contact for medical writing projects within REV Clinical, independently preparing, reviewing, and finalizing clinical and regulatory documents, from concept sheets and study protocols through Module 2 summaries, regulatory submissions, and scientific publications. The role works closely with Project Management, Data Management, Biostatistics, Medical Monitoring, and QA to ensure accurate, high-quality documents are delivered on schedule and in compliance with applicable regulatory and quality standards. This is a remote position suited to a medical writing professional with 3-6 years of experience.

KEY RESPONSIBILITIES

Medical Writing Ownership & Study Documents

• Act as the primary point of contact for medical writing projects within REV Clinical
• Independently prepare, review, and finalize concept sheets
• Prepare clinical study protocols in compliance with applicable regulatory requirements, along with associated study documents such as ICF, CRF, and IB
• Review and finalize study-specific Project Management plans, in consultation with the respective Project Manager

Regulatory Documentation

• Independently prepare, review, and finalize Module 2 documents, including clinical and non-clinical overviews and summaries
• Prepare regulatory documents such as briefing documents, controlled correspondence or scientific advice, and regulatory applications for orphan drug designation, fast track designation, and accelerated approval
• Review clinical study reports and study report compilation in compliance with applicable regulatory requirements
• Review the Statistical Analysis Plan (SAP) and study results

SEC Presentations & Scientific Communication

• Prepare, review, and finalize Subject Expert Committee (SEC) presentations in consultation with the Medical Monitor and other stakeholders
• Prepare manuscripts for peer-reviewed publications
• Prepare abstracts, slide presentations, and poster presentations for scientific meetings within and outside India
• Assist in the review and preparation of summary documents that support the clinical/scientific needs of a project

Stakeholder Collaboration

• Interact with all stakeholders involved in document preparation, including Project Management, Data Management, Biostatistics, Medical Monitor, and QA

Quality, Timelines & Team Management

• Ensure accurate, high-quality documents are prepared on schedule in line with the project timeline
• Ensure compliance with the quality standard requirements of the quality management system, including relevant documentation and filing
• Ensure proper team management
• Perform any other tasks assigned by the HOD or designee

QUALIFICATIONS

• Degree in Life Sciences, Pharmacy, Medicine, or a related discipline; advanced degree preferred
• 3-6 years of experience in medical writing within a CRO, pharmaceutical, or biotech environment
• Demonstrated experience authoring clinical study protocols, ICFs, IBs, and concept sheets
• Experience authoring Module 2 clinical and non-clinical overviews and summaries
• Exposure to regulatory documents such as briefing documents, scientific advice, orphan drug and fast track applications
• Experience reviewing CSRs, SAPs, and study results
• Working knowledge of ICH-GCP and applicable global regulatory guidelines (FDA, EMA, CDSCO)
• Experience preparing manuscripts, abstracts, and scientific presentations is an advantage

SKILLS/ABILITIES

• Exceptional scientific and regulatory writing skills, with the ability to present complex data clearly
• Ability to work independently as the primary point of contact for medical writing projects
• Strong attention to detail and commitment to quality across all document types
• Effective communication and stakeholder management across cross-functional teams
• Ability to manage multiple documents and deadlines simultaneously
• Ability to guide and coordinate team members
• Working knowledge of quality management systems and documentation/filing requirements
• Ability to work independently in a remote setting

COMPENSATION

An attractive compensation package commensurate with experience will be provided.