CT Submission Specialist – Structured Job Description
Location: Hyderabad, Telangana, India
Division: Research & Development
Department: Global Development Operations → Trial Delivery Support (TDS) → Trial Risk & Integrity Management (TRIM) → CT Transparency & Submission
Job Type: Full-time
📌 Position Title
GDO Submission Document Specialist
🎯 Position Objective
Support the creation, coordination, and quality of operational deliverables required for FDA clinical submissions, ensuring timely, accurate, and compliant documentation.
🧩 Key Responsibilities
1. Submission Document Support
Prepare and perform quality checks on clinical submission deliverables.
Support development and finalization of protocol-related submission documents.
Ensure all documents meet Submission Ready Compliance (SRC) and formatting standards.
2. Cross-Functional Collaboration
Work closely with Clinical Trial Support Specialists (CTSS) on:
CSR appendices
Financial Disclosure Tables
Submission-related tables and documentation
3. Risk & Issue Management
Identify document issues and coordinate timely resolutions.
Escalate potential risks to functional management or stakeholders.
Use critical thinking to propose mitigation and solution strategies.
4. Documentation & Quality
Maintain high-quality standards for:
Protocol-related documents
Templates and core document structures
Document compliance systems
Assist with other tasks supporting Clinical Trials.
🎓 Education Requirements
Bachelor’s Degree in:
Life Sciences
Business Administration
Or equivalent relevant experience
Advanced degree is a plus.
💼 Experience Requirements
3–4 years total experience in pharma/biotech/clinical drug development.
1–2 years directly in:
Clinical trial documentation
Document management systems
Clinical submission workflows
Strong understanding of:
ICH–GCP
Clinical development process
Pharma regulatory guidelines
Technical Experience
TMF systems (Veeva Vault Clinical preferred)
CTMS tools (Veeva Vault CTMS preferred)
MS Office, SharePoint
Document creation & management using core templates
🧠 Key Competencies
Project & Time Management
Strong organizational and project management skills
Ability to handle multiple priorities and shifting timelines
Communication
Excellent written and verbal communication
Ability to influence in a cross-functional matrix environment
Technical Strengths
Solid understanding of protocol documents
Good command of document management systems
Strong analytical and decision-making ability
Work Style
Independent, proactive, detail-oriented
Flexible and adaptable to evolving business needs
Able to work with cross-cultural teams
🏢 Work Model
This role follows BMS On-site Protocol:
Site-by-design OR hybrid requirement (minimum 50% onsite).
Onsite presence is essential for collaboration and productivity.
🌍 Company Values
BMS promotes:
Passion
Innovation
Urgency
Accountability
Inclusion
Integrity
Their mission: Transforming patients’ lives through science
Andra Pradesh :
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Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
Goa | Panaji | Verna |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Baddi | Solan |India :
Siliguri |Jharkhand :
Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
Tuscaloosa |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
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Wilmington |Florida :
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Hilo | Honolulu |Idaho :
Boise |Illinois :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Kington :
Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
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Dickinson |northeastern :
New Hampshire |Ohio :
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Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |Carlow :
Carlow |Cork :
Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Australia | Mississauga | North York | Renfrew | Richmond Hill | Uxbridge |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Tel Aviv | Netanya | Be'Er Sheva | Yavne |Italy :
Italy |Lombardy :
Rho |Japan :
Saitama | Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |New Zealand :
New Zealand |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Hammond | Zaragoza | Remote | Faridabad | Remote - Middle East | Tulsa | Riga | Manipal | Medan | Victoria | Castlebar | McFarland | Lousiana | Blue Bell | Remote - Europe | Remote - Africa | Melbourne | Texas | French | Ireland | Slovakia | Switzerland | Lenexa | Xzagreb | Minnesota | Bishop | Springville | Leinster | Belgium | Thailand | Nairobi | Bountiful | Hungary | Green Way | Remote, USA | Remote - South America (Latin Americal) |Bucharest :
Bucharest |Makkah :
Jeddah | Rabigh | Riyadh | Khulais | Najran | King Abdullah Economic City |Nišava District :
Niš |Singapore :
Singapore |South Africa :
South Africa | Midrand |Brazil :
Sao paulo | Brazil |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |