Senior Medical Writer
Location: India-Asia Pacific - IND-Home-Based
Updated: May 8, 2025
Job ID: 24003298
Description:
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything we do. We continuously seek ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.
Whether in a Functional Service Provider partnership or Full-Service environment, you will collaborate with passionate problem solvers, innovating as a team to help customers achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing lives.
Why Syneos Health:
Passionate about developing people through career development and progression, supportive line management, and technical/therapeutic training.
Committed to a Total Self culture where you can authentically be yourself.
Embracing diversity of thoughts, backgrounds, cultures, and perspectives to create a workplace where everyone feels they belong.
Job Responsibilities:
Mentor and lead less experienced medical writers on complex projects as needed.
Act as lead for assigned writing projects.
Manage medical writing activities associated with individual studies with minimal supervision.
Develop or support various documents including:
Clinical study protocols and amendments
Clinical study reports
Patient narratives
Clinical development plans
IND submissions and annual reports
Integrated summary reports
NDA and (e)CTD submissions
Investigator brochures
Clinical journal manuscripts, abstracts, and client presentations
Identify and propose solutions for issues arising during writing, escalating when appropriate.
Review statistical analysis plans and table/figure/listing specifications for content, grammar, and consistency.
Collaborate with data management, biostatistics, regulatory affairs, and medical affairs teams as needed.
Serve as a peer reviewer on internal review teams.
Adhere to regulatory standards (e.g., ICH-E3), SOPs, client standards, and approved templates.
Perform clinical literature searches as applicable.
Maintain familiarity with industry practices, regulatory requirements, and guidelines affecting medical writing.
Manage budgets and communicate changes to leadership.
Complete administrative tasks on time.
Perform other duties as assigned. Minimal travel (<25%) may be required.
Qualifications:
Bachelor of Science degree with relevant writing experience, or Bachelor of Arts (Social Sciences, English, Communications preferred) with scientific/medical knowledge.
Extensive knowledge of English grammar, FDA and ICH regulations, and familiarity with AMA style guide.
High degree of independence with strong presentation, proofreading, interpersonal, and leadership skills.
Proficient in Word, Excel, PowerPoint, email, and Internet.
Familiarity with clinical research principles and ability to interpret and present clinical data and complex information.
About Syneos Health:
Over the past 5 years, we have worked with 94% of Novel FDA Approved Drugs, 95% of EMA Authorized Products, 200+ studies across 73,000 sites, and 675,000+ trial patients.
We encourage initiative and challenging the status quo in a highly competitive and evolving environment.
Additional Information:
Tasks and responsibilities are not exhaustive and may change at the company's discretion. Equivalent experience or education may be considered. This is not a contract of employment. The company complies with all legal obligations including the EU Equality Directive and the Americans with Disabilities Act.
Estimated Salary: ₹8,00,000 - ₹12,00,000 per annum (based on market standards in India for senior medical writer roles)
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Maharashtra :
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Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Ranchi |Sikkim :
Rangpo |India :
Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
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Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
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 :
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 | Newark | New Brunswick | 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 | Westfield | West Orange | Wharton | Whippany |Ohio :
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Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
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Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
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Ingelheim am Rhein | Mainz |Schleswig Holstein :
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Saarbrucken |Switzerland :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
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Wuhan |Capital of Netherland :
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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 :
Uxbridge | North York | Mississauga | Renfrew | Richmond Hill | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
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Zaventem |South America :
Peru | Argentina |Brazil :
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Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
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Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
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Japan | Saitama |Tokyo :
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Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
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Bangkok |Israel :
Kfar Saba | Yavne | Be'Er Sheva | Tel Aviv | Netanya |Remote :
Ireland | McFarland | Faridabad | Remote, USA | Minnesota | Remote | Thailand | Zaragoza | Remote - Middle East | Texas | Victoria | Belgium | Xzagreb | Medan | Melbourne | Nairobi | Hammond | Lenexa | Remote - Africa | Remote - South America (Latin Americal) | Green Way | Bountiful | Bishop | Blue Bell | Regulatory Labeling Manager (NA and LATAM Only) | Remote - Europe | Hungary | Springville | Manipal | French | Switzerland | Tulsa | Lousiana | Riga | Slovakia | Leinster | Castlebar |Republic of Colombia :
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Buenos Aires |Republic of Egypt :
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Ciudad de México | New Mexico |Dubai :
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Khulais | Riyadh | Jeddah | Najran | King Abdullah Economic City | Rabigh |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
South Africa | Midrand |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
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Singapore |Sofia City :
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