Job Title: Associate Manager - Scientific Writing
Date Posted: 23 Aug 2025
Location: Bangalore, KA, India
Education:
MBBS / PhD / MDS / BDS / MPharm / PharmD
Experience:
10–12 years in clinical and regulatory document writing supporting global filings (CTD Module 2 and Module 5)
Role Purpose:
Responsible for managing complex medical writing projects, providing review support for clinical regulatory writing deliverables, and training junior writers.
Key Skills:
Medical & Scientific Expertise:
Author a wide range of clinical documents supporting regulatory filings (Modules 2.4, 2.5, 2.6, 2.7, 5.2), clinical study reports (CSRs), protocols, amendments, ICFs, Investigator Brochures (IBs).
Focused/lean writing and editing following defined processes and templates.
Lead cross-functional teams to draft scientific content addressing data interpretation, product claims, and internal/external questions.
Understanding of clinical development from program planning to submission, including trial design.
Ability to work independently while coordinating with Sponsor’s MW project manager.
Flexibility to work across therapeutic areas to support business continuity.
Develop and oversee work plans for individual and multiple-document deliveries, including timelines, tasks, and assigned responsibilities.
Facilitate review meetings, address feedback, and negotiate solutions.
People Management:
Minimum 2 years of experience in people management.
Ability to manage authoring teams, internal/external contributors, and reviewers efficiently.
Technology Skills:
Expert in MS Word and advanced functionalities.
Experience with document management systems, workflow approvals, and eSignatures.
Experience with Word add-ins for managing fonts, styles, references.
Ability to train writers/authors on templates, guidelines, and tools.
Communication & Interpersonal Skills:
Strong communication, organizational, and time management skills.
Customer-focused and able to work collaboratively in a professional environment.
Knowledge Requirements:
Scientific Knowledge:
Strong knowledge of global regulatory guidelines (FDA, EMA, ICH) and regional standards.
Ability to interpret data and apply scientific knowledge for regulatory documents (IB, protocols, amendments, CSRs, Clinical Summaries).
Build clinical/regulatory arguments in absence of direct data using logic and therapeutic area knowledge.
Understand medical practices, procedures, medications, and treatment strategies.
Ensure messaging consistency aligned with historical data and agreed strategies.
Provide insights and suggestions based on prior experience.
Responsibilities:
Prepare/review CSRs, protocols, IBs, submission documents (Module 2 summaries), and other regulatory documents independently.
Apply lean authoring principles and structured content management libraries.
Coordinate document review, consensus meetings, quality control, and finalization under tight timelines.
Develop and maintain project plans and team work plans.
Lead and manage team members, including orientation and mentoring of junior writers.
Participate as an active member of cross-functional teams representing Medical Writing.
Coordinate and deliver document kick-off meetings with writers and stakeholders.
Ensure adherence to standard content, lean authoring, and messaging consistency.
Conduct literature searches and screening as needed.
Participate in departmental initiatives and share best practices.
Stay updated on regulatory requirements and research industry trends.
Ensure compliance with company training and time reporting requirements.
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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 :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
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Chengdu | Garden city | Kansas City | Lawrence | McPherson |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Kington :
Frank Scottile Blvd |LA :
Baton Rouge | Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maine :
Bangor | Brewer |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Massachusetts :
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 :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | New Brunswick | Newark | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | West Orange | Westfield | Wharton | Whippany |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
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Concord | Lumberton | North Carolina |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
New Hampshire |Ohio :
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Mexico |South Carolina :
Charleston |Tennessee :
Knoxville | Memphis | Nashville |Texas :
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Hawai | kentucky | Sylmar | Woonsocket |Virginia :
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Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
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 :
Uxbridge | Australia | Mississauga | North York | Richmond Hill | Renfrew |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Tartu | Estonia |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 | Netanya | Yavne | Be'Er Sheva | Tel Aviv |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |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 :
Hungary | French | Springville | Tulsa | Lousiana | Lenexa | Remote - South America (Latin Americal) | Belgium | Medan | Hammond | Victoria | Bishop | Melbourne | Remote - Africa | Texas | Minnesota | Xzagreb | McFarland | Leinster | Faridabad | Thailand | Castlebar | Ireland | Remote, USA | Blue Bell | Slovakia | Remote - Europe | Manipal | Remote | Green Way | Remote - Middle East | Bountiful | Zaragoza | Nairobi | Switzerland | Riga |Bucharest :
Bucharest |Makkah :
Najran | Jeddah | King Abdullah Economic City | Rabigh | Riyadh | Khulais |Nišava District :
Niš |Singapore :
Singapore |South Africa :
South Africa | Midrand |Brazil :
Brazil | Sao paulo |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 |