{"id":2513336,"url":"https://alion.io/job/quanticate-document-specialist-consultant","title":"Document Specialist (Consultant)","company":{"id":684644,"name":"Quanticate","domain":"quanticate.com","url":"https://alion.io/company/quanticate","size_band":"201-500","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"Workable","truth_index":{"grade":"B","score":75,"open_postings":3,"ghost_share":0,"stale_share":1,"repost_share":0,"time_to_fill_p50_days":null,"computed_at":"2026-10-28T05:59:10Z"}},"role":"Biotech","role_family":"Biotech","seniority":null,"employment_type":"contractor","work_mode":"remote","remote_scope":"stated_countries","remote_scope_basis":"board_field","remote_working_hours":null,"hiring_geo_confidence":"structured","locations":[],"countries":[],"hiring_countries":["IN"],"hiring_countries_total":1,"salary":null,"salary_estimate":null,"experience_years_min":null,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[{"name":"GCP","optional":false},{"name":"ICH Guidelines","optional":false}],"status":"live","first_seen_at":"2026-10-14T09:22:31Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-28T14:59:09Z","board_verified":true,"closed_at":null,"days_open":14,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":14},"description":"Are you passionate about delivering high-quality clinical and regulatory documents that support global submissions and clinical trial transparency? We are looking for a Document Specialist (Consultant) to join our team and play a key role in the formatting, publishing, quality control, and disclosure-related redaction of clinical and regulatory documentation.\nWorking closely with Medical Writing, Regulatory Affairs, Clinical Operations, and other cross-functional teams, you will ensure that documents meet the highest standards of quality, consistency, and regulatory compliance.\nDocument Publishing & Compilation\nCompile, format, and publish Clinical Study Reports (CSRs) and associated appendices in line with ICH E3 guidance and sponsor requirements.\nPrepare submission-ready PDF documents with bookmarks, hyperlinks, cross-references, navigation tools, and tables of contents.\nCompile and publish a variety of clinical and regulatory documents for global submissions.\nAssemble appendices and supporting documentation received from multiple teams and external vendors.\nEnsure consistency in formatting, styles, numbering, references, and document structure across all deliverables.\nQuality Control\nPerform comprehensive document-level QC reviews to ensure: \nAccurate formatting and pagination\nFunctional hyperlinks and bookmarks\nCorrect cross-references\nConsistent tables, figures, and listings\nOverall document completeness and quality\nEnsure compliance with sponsor templates, SOPs, and regulatory requirements.\nPartner with authors and reviewers to resolve publishing, formatting, and quality issues.\nDisclosure & Redaction\nPerform redaction of clinical and regulatory documents to support: \nClinicalTrials.gov submissions\nCTIS submissions\nEudraCT disclosure activities\nPublic disclosure and transparency requirements\nRedact confidential commercial information (CCI) and personal data according to applicable regulations and sponsor guidance.\nConduct QC reviews of redacted documents before publication or submission.\nRegulatory Operations Support\nSupport the preparation of submission-ready electronic document packages.\nAssist with document lifecycle management, version control, and archival activities.\nMaintain publishing standards, templates, and document management processes.\nContribute to inspection and audit readiness activities.\nCollaboration & Continuous Improvement\nWork closely with Medical Writing, Regulatory Affairs, Biostatistics & Programming, Clinical Data Management, Pharmacovigilance, Project Management, and Quality teams.\nShare knowledge, mentor colleagues, and promote best practices across projects.\nSupport process improvement initiatives and contribute to operational excellence.\nStay current with evolving regulatory guidelines and industry best practices.\nQuanticate is the world leading data-focused CRO, and we often work with our customers on their complicated clinical trials which require a high level of statistical programming, statistics and data management input. We need talented individuals to help us fulfil our customers’ needs.\nOur customers range from top global pharmaceutical companies where you can work as an integrated team member on a world leading clinical program, to small biotechs that are taking their first steps in clinical development\nWe strongly advocate career development providing membership to professional societies, encouraging your involvement in their activities and committees. Together we can help you build the career you want - developing your skills, working on challenging problems, to ultimately develop clinical therapies that matter.\nRequirements\nEducation\nBachelor's degree in Life Sciences, Pharmacy, Biotechnology, Medical Sciences, or a related discipline.\nExperience\nMinimum 3 years of experience in Regulatory Publishing, Medical Writing Operations, Document Publishing, or Regulatory Operations within a pharmaceutical, biotechnology, or CRO environment.\nHands-on experience compiling and publishing Clinical Study Reports (CSRs) and appendices.\nExperience creating and maintaining bookmarks, hyperlinks, cross-references, and navigation features in large regulatory documents.\nExperience using Adobe Acrobat Professional and document publishing software.\nExperience conducting document quality control reviews.\nExperience redacting Protocols, SAPs, CSRs, and other clinical documents for regulatory disclosure and transparency requirements.\nTechnical Skills\nAdvanced proficiency in Microsoft Word, Adobe Acrobat, and document formatting tools.\nStrong understanding of clinical and regulatory documentation standards.\nKnowledge of GCP, regulatory submission processes, and transparency requirements.\nExperience with document management systems, version control, and document lifecycle management.\nPersonal Skills\nExcellent written and verbal communication skills.\nExceptional attention to detail and quality focus.\nStrong planning, organisational, and prioritisation skills.\nAbility to manage multiple deliverables and meet deadlines in a fast-paced environment.\nAnalytical mindset with strong problem-solving capabilities.\nSelf-motivated with the ability to work independently and collaboratively.\nStrong interpersonal and stakeholder management skills.\nQuanticate will never ask for payments as part of the recruitment or hiring process, and all legitimate correspondence from Quanticate will come exclusively from our @quanticate.com domain name. Hiring at Quanticate is based purely on merit and we do not ask or require candidates to deposit any money or complete any paid for courses as part of the process. Further guidance on our recruitment process and tips on how to stay safe during your job search can be found on our website at https://www.quanticate.com/careers-guidance.\nBenefits\nCompetitive salary \nFlexible working hours\nHolidays (Annual Leave, Sick Leave, Casual Leave and Bank holidays)\nMedical Insurance for self and immediate family\nGratuity\nAccidental Coverage \nQuanticate offers a variety of different learning development opportunities to help you progress (mentoring, coaching, e- learning, job shadowing)","description_format":"text","description_chars":6127,"description_truncated":false,"requirements":{"experience_years_min":null,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"bachelor","optional":false},"security_clearance":false,"languages":[]},"benefits":["Annual leave","Flexible schedule","Health insurance"],"hiring_locations":[{"name":"India","iso":"IN","kind":"country"}],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Clinical Trial Services (CRO)"],"lifecycle":[{"event":"open","at":"2026-10-14T09:22:31Z"}],"visa":[],"liveness":{"score":71,"band":"hot","label":"Hiring now","p_open":1,"p_active":0.789,"p_room":0.9,"age_days":13,"expected_fill_days":20,"reasons":["conf:8","win:mid"],"computed_at":"2026-10-28T05:59:10Z"},"pay":null,"html_url":"https://alion.io/job/quanticate-document-specialist-consultant","json_url":"https://alion.io/job/quanticate-document-specialist-consultant.json","meta":{"generated_at":"2026-10-28T21:25:56Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":29555,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-29T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":684644},"rest":"https://alion.io/mcp/rest/get_company?id=684644"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fquanticate-document-specialist-consultant"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fquanticate-document-specialist-consultant"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fquanticate-document-specialist-consultant"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/quanticate-document-specialist-consultant\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fquanticate-document-specialist-consultant"}],"agent":{"mcp":"https://alion.io/mcp/jobs","mcp_open":"https://alion.io/mcp/open","next":[{"tool":"get_job","arguments":{"id":2513336}},{"tool":"search_jobs","arguments":{"company":"quanticate.com","detail":"compact"}},{"tool":"match_people","arguments":{"job_id":2513336},"note":"people open to offers who fit this vacancy"}],"note":"The same data through MCP tools: https://alion.io/mcp/open needs no sign-in (compact searches, postings, people); https://alion.io/mcp with an Alion account has everything. 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