Quanticate Hiring for Medical Writer (Consultant) and Document Specialist (Consultant)

Quanticate is hiring for two contract positions in its Medical Writing function: Medical Writer (Consultant) and Document Specialist (Consultant). Both positions offer remote work opportunities in India and involve clinical and regulatory documentation supporting clinical development programmes, regulatory submissions, and clinical trial transparency.

Candidates with relevant experience in medical writing, regulatory publishing, clinical document compilation, and document quality control can review the eligibility criteria and apply through the official job links provided below.

Quanticate Recruitment 2026 – Job Details

1. Medical Writer (Consultant)

Job Location: Bengaluru, Karnataka, India
Work Mode: Remote
Job ID: ATR 2176

Job Responsibilities

• Author, review, and quality-check Clinical Study Reports (CSRs) and other scientific and regulatory documents.
• Ensure documentation accurately reflects source data and complies with regulatory requirements, company standards, and client expectations.
• Manage document review cycles and resolve comments from reviewers and stakeholders.
• Perform proofreading, editorial support, and quality control reviews.
• Support document publishing and preparation of submission-ready deliverables.
• Manage multiple writing projects, monitor milestones, and track project progress, risks, and timelines.
• Coordinate with project teams, reviewers, subject matter experts, and clients.
• Maintain project records, time reporting, and tracking metrics.
• Support proposal development, bid defence meetings, and business development activities.
• Mentor junior Medical Writers and contribute to training and process improvement initiatives.
• Stay updated on regulatory requirements, Good Clinical Practice (GCP) standards, and scientific communication guidelines.

Eligibility and Qualifications

• Master’s degree in Life Sciences, Medical Sciences, Pharmacy, or a related scientific discipline.
• Minimum 4 years of medical writing experience in the pharmaceutical, biotechnology, CRO, or healthcare sector.
• Strong experience preparing regulatory and scientific documents.
• Understanding of regulatory requirements and scientific communication guidelines.
• Experience mentoring or supporting colleagues.

Desirable qualification: PhD, PharmD, MD, MVSc, or an equivalent advanced qualification.

Publications in peer-reviewed scientific literature are an advantage.

Required Skills

• Excellent written and verbal communication.
• Ability to translate complex scientific concepts into clear, concise content.
• Strong attention to detail and quality assurance.
• Project management, organisation, and prioritisation.
• Analytical and problem-solving abilities.
• Stakeholder management, influencing, and negotiation.
• Proficiency in Microsoft Office and document management systems.
• Ability to work independently and collaboratively.

2. Document Specialist (Consultant)

Job Location: India
Work Mode: Remote
Job ID: ATR 2177

Job Responsibilities

• Compile, format, and publish Clinical Study Reports (CSRs) and appendices according to ICH E3 guidance and sponsor requirements.
• Prepare submission-ready PDF documents with bookmarks, hyperlinks, cross-references, navigation tools, and tables of contents.
• Compile clinical and regulatory documentation for global submissions.
• Perform document-level quality control to verify formatting, pagination, hyperlinks, bookmarks, cross-references, tables, figures, listings, and completeness.
• Ensure compliance with sponsor templates, standard operating procedures (SOPs), and regulatory requirements.
• Redact confidential commercial information (CCI) and personal data in clinical and regulatory documents.
• Support disclosure activities for ClinicalTrials.gov, CTIS, and EudraCT.
• Conduct quality checks on redacted documents before publication or submission.
• Support electronic submission packages, version control, document lifecycle management, and archiving.
• Maintain publishing standards and contribute to inspection and audit readiness.
• Collaborate with Medical Writing, Regulatory Affairs, Biostatistics and Programming, Clinical Data Management, Pharmacovigilance, Project Management, and Quality teams.
• Support mentoring, knowledge sharing, and process improvement initiatives.

Eligibility and Qualifications

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Medical Sciences, or a related discipline.
• Minimum 3 years of experience in Regulatory Publishing, Medical Writing Operations, Document Publishing, or Regulatory Operations within a pharmaceutical, biotechnology, or CRO environment.
• Hands-on experience compiling and publishing CSRs and appendices.
• Experience creating bookmarks, hyperlinks, cross-references, and navigation features in large regulatory documents.
• Experience using Adobe Acrobat Professional and document publishing software.
• Experience conducting document quality control reviews.
• Experience redacting protocols, Statistical Analysis Plans (SAPs), CSRs, and other clinical documents for regulatory disclosure and transparency requirements.

Required Skills

• Advanced proficiency in Microsoft Word, Adobe Acrobat, and document formatting tools.
• Understanding of clinical and regulatory documentation standards.
• Knowledge of GCP, regulatory submission processes, and transparency requirements.
• Experience with document management systems, version control, and document lifecycle management.
• Excellent written and verbal communication.
• Strong attention to detail, organisation, and prioritisation.
• Ability to manage multiple deliverables and meet deadlines.
• Analytical and problem-solving skills.
• Ability to work independently and collaboratively with stakeholders.