Company: Thermo Fisher Scientific / PPD
Thermo Fisher Scientific Careers
Work Mode: Remote / FSP (Functional Service Partnership)
Schedule: Standard (Mon–Fri)
Environment: Office / Remote Clinical Documentation Support
1. Role Overview
The Document Review Specialist II is a specialized medical/regulatory document quality reviewer responsible for ensuring scientific, editorial, formatting, and regulatory accuracy across clinical and regulatory documents.
The role sits within Medical Writing / Regulatory Documentation Operations and supports pharmaceutical or biotech clients in an FSP model.
Primary focus areas include:
Scientific consistency
Regulatory compliance
Editorial quality
Template and style guide adherence
This is not a primary authoring role; it is a high-level review and QC role for regulated scientific documents.
2. Core Responsibilities
A. Regulatory & Scientific Document Review
Review highly technical clinical and regulatory documents including:
Clinical Study Reports (CSRs)
Clinical Protocols & Amendments
Investigator Brochures (IBs)
Informed Consent Forms (ICFs)
Patient Safety Narratives
Submission documents
Ensure:
Scientific clarity
Logical consistency
Regulatory compliance
Editorial accuracy
B. Data Verification & Quality Control
Verify tables, listings, and figures against source documents
Check consistency of:
Data presentation
Terminology
Statistical references
Regulatory language
Ensure documents meet:
Client templates
Editorial standards
Industry guidelines
C. Editing & Language Refinement
Edit grammar, punctuation, syntax, and scientific wording
Improve:
Readability
Flow
Audience appropriateness
Refine technical scientific language while preserving scientific meaning
D. Regulatory Compliance & Standards
Maintain working knowledge of:
ICH guidelines
GCP standards
FDA and international regulatory expectations
Client-specific style guides and templates
Ensure all deliverables comply with evolving regulatory standards.
E. Stakeholder Collaboration
Work directly with medical writers and document authors
Raise scientific/editorial queries proactively
Support geographically distributed global teams
Adjust timelines to support urgent priority reviews
F. Document Systems & Formatting
Work within document management systems (DMS)
Support Word formatting/template compliance
Ensure standardized formatting and structure across submissions
3. Required Qualifications
Education
Bachelor’s degree or equivalent qualification required
Experience
Minimum 2+ years reviewing:
CSRs
Protocols
ICFs
Investigator Brochures
Regulatory documents
Pharmaceutical or CRO experience preferred
FSP/client-dedicated experience preferred
4. Core Skills
Scientific & Regulatory Skills
Medical and regulatory document review
Scientific editing and QC
Understanding of:
Clinical research
Regulatory submissions
GCP/ICH guidelines
Statistical concepts
Editorial & Language Skills
Advanced English proficiency
Scientific grammar and style editing
Clarity and consistency improvement
Attention to detail
Technical Skills
Document Management Systems (DMS)
Microsoft Word advanced formatting
Template compliance management
Regulatory publishing awareness
Behavioral Skills
Ability to work under pressure
Strong analytical thinking
Cross-cultural collaboration
Organizational and planning skills
Independent and team-based work capability
5. Key Skill Areas
Medical Writing QC
Regulatory Document Review
CSR / Protocol / IB Review
Scientific Editing
GCP / ICH Compliance
Document Management Systems
6. Organizational Context
This role belongs to the Medical Writing Functional Service Partnership (FSP) model, where dedicated teams support specific pharma/biotech clients long-term.
It is positioned between:
Medical Writing
Regulatory Operations
Quality Control / Editorial Review
7. Relative Career Positioning
Compared to the other roles you shared:
More Specialized In:
Scientific QC and editing
Regulatory documentation review
Submission document quality assurance
Less Focused On:
Clinical operations/site monitoring
Pharmacovigilance systems
Lab or manufacturing work
8. Career Growth Path
Typical progression:
Document Review Specialist II
→ Senior Regulatory Editor
→ Principal Medical Editor
→ Medical Writing Lead
→ Regulatory Writing Manager
→ Medical Communications Director
9. Best Fit Profile
This role is especially suitable for candidates with:
Medical writing background
Strong English/scientific editing skills
Pharmacy/life sciences education
Regulatory documentation exposure
Preference for low-travel, desk-based scientific work
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Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
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Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
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Bloomington | West Lafayette |Florida :
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Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
North York | Richmond Hill | Australia | Mississauga | Renfrew | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Argentina | Peru |Brazil :
Brazil | Sao paulo |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Vienna |Catalonia :
Barcelona |Madrid :
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Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
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Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Yavne | Tel Aviv | Kfar Saba | Netanya | Be'Er Sheva |Remote :
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Bogota |Williamson :
Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
Ciudad de México | New Mexico |Dubai :
Dubai |Makkah :
King Abdullah Economic City | Jeddah | Najran | Rabigh | Khulais | Riyadh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Lyon | Paris |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
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