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Medical Writer Ii (Csr Narratives)

Syneos Health
Syneos Health
1-2 years
Not Disclosed
Aachen Abbott Park Aberdeen Abilene Adelanto Ahmedabad Airoli Alameda Albany Albion Albuquerque Almaty Ambala Ambernath Ambler Amravati Amsterdam Anakapali Anantapur Anchorage Andover Ankleshwar Annamalainagar Appleton Arcata Argentina Arizona Arkansas Arlington Athens Atherton Atlanta Auckland Augusta Aurangabad Austin Australia Austria Baddi Ballina Ballydine Baltimore Banasthali Bangalore Bangkok Bangor Barcelona Baroda Barrow Basel Basking Ridge Batavia Bathinda Baton Rouge Bavaria Bayreuth Be'Er Sheva Beijing Bela Bel Air Belgaum Belgium Belgrade Bellevue Bend Bengaluru Berkeley Berlin Bethel Bethlehem B.G Nagara Bharuch Bhimavaram Bhiwadi Bhopal Bhubaneswar Biberach an der Riß Biddle Bielefeld Big Piney Bilaspur Billerica Birmingham Bishop Blacksburg Bloomfield Bloomingdale Bloomington Blue Ash Blue Bell Boca Raton Bochum Boerne Bogota Boise Bommasandra Bonn Boston Bothell Boulder Bountiful Branchburg Township Brazil Breda Brenham Brentwood Brewer Bridgeport Bridgewater Brinny Brisbane Bristol Brooklyn Brooksville Brunswick Brussels Bucharest Budapest Buenos Aires Buffalo Buffalo Grove Bulgaria Bulverde Burlingame Burlington Burney Cairo California Cambridge Canada Carlow Carlsbad Carolina Beach Carrollton Castlebar Cebu City Cedar Hill Champaign Chandigarh Chandler Chapel Hills Charleston Charlotte Charlottesville Chengdu Chennai Chessington Cheverly Chicago China Chittoor Cincinnati Ciudad de México Clark Clayton Clearwater Cleveland Coimbatore Cokeville Collegeville Cologne Colorado Columbia Columbus, Concord Cooper City Copenhagen Coquille Coral Gables Coral Springs Cork Corpus Christi Corsicana Corvallis Cranbury Crescent City Croatia Czech Republic Dalian Dallas Darmstadt Davis Dayton Daytona Beach Deerfield Dehradun Delhi Denmark Denton Denver Detroit Devens Dewas Dhule Dibrugarh Diburghar Dickinson Digha Dombivali Donegal Dortmund Downers Grove Downey Dubai Dublin Duisburg Duluth Dunboyne Dunellen Dún Laoghaire Durham Dusseldorf East Brunswick Eden Prairie Edgewood Edison Elkridge El Monte El Paso El Segundo Emeryville Enfield England Eot Municipality Erie Erlangen Erode Estonia Eugene Eureka Evendale Fairfield fairmont Falls Church Far Hills Faridabad Farmington Finland Flemington Florence Florida Fort Smith Fortuna Fort Worth Foster City France Frankfurt Franklin Frank Scottile Blvd Freiburg Fremont French Friday Harbor Fridley Ft MItchell Fulton Gainesville Gaithersburg Gajraula Galway Gandhinagar Garden city Garland Gautam buddha Nagar Georgia Germany GErmany Ghaziabad Glendale Glenview Goa Goldendale Gorakhpur Gottingen Grants Pass Greater Noida Greece Green Way Grenzach Groton Gujarat Guntur Gurgaon Gurugram Guwahati Gwalior Haarlem Hackensack Hajipur Halifax Halle Halol Hamburg Hamilton Hammond Hangzhou Hannover Hanoi Hà Nội Hanumakonda Harlow Harrisburg Harrogate Hartford Harveysburg Haryana Hauppauge Hawai Hawthorne Hayward Hebron Heidelberg Heist op den Berg Hibbing Hicksville Hilo Hisar Ho Chi Minh City Holly Springs Hollywood Honolulu Hoopa Hopewell Houghton Lake Houston Huber Heights Hungary Hyderabad India Indianapolis Indore Ingelheim am Rhein Ireland Irvine Istanbul Italy Ithaca Jacksonville Jaipur Jakarta Jalgaon Japan Jeddah Jersey City Jhagadia Jhansi John Day Juneau Kannur Kansas City Karlsruhe Karnataka Keene Kenosha kentucky Kfar Saba Khandwa Khargone Khulais Kiel King Abdullah Economic City Kingman Kings Mills Knoxville Kochi Kolhapur Kolkata Konstanz Koropi Kuala Lumpur Kurkumbh Kurla Kurukshetra Kyiv La Jolla Lake Charles Lake Forest Lake Havasu City Lake Oswego Lakeview Lakeway Lancaster Largo Larne Las Vegas Latvia Lawrence Lebanon Leeds Leiden Leinster Leipzig Lendava Lenexa Leuven Lexington Lima Limerick Linden Linthicum Lisbon Livingston Lombard London Longview Los Angeles Louisville Lousiana Lucknow ludhiana Lumberton Lyndhurst Lyon Macedonia Macomb Macon Madhapur Madison Madrid Madurai Mahabubnagar Mahwah Maidenhead Mainz Maitland Malappuram Malaysia Manchester Mangalagiri Mangaluru Manila Manipal Maple Grove Marburg Marietta Marsa Martinez Mason Massachusetts Mathura Mcallen McFarland McKinleyville McPherson Mechanicsville Medak Medan Medford and Somerville Mehsana Melbourne Memphis Menlo Park Mesa Mexico Miami Michigan Middleburgh Middletown Midrand Milan Milford Millbrae Milpitas Minneapolis and St. Paul, Minnesota. 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10 Oct. 19, 2025
Job Description
Job Type: Full Time Hybrid Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Medical Writer II (CSR Narratives)

📅 Updated: October 15, 2025
📍 Location: Gurugram – Hybrid
🆔 Job ID: 25102321


Company Overview

Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success by translating clinical, medical affairs, and commercial insights into actionable outcomes.

Culture & Values:

  • Career development, technical/therapeutic training, peer recognition, and total rewards.

  • Total Self culture: supports authenticity, inclusion, and belonging.

  • Emphasis on collaboration, innovation, and agility to improve therapy delivery and client outcomes.

Global Impact:

  • Worked with 94% of novel FDA-approved drugs and 95% EMA-authorized products.

  • Conducted 200+ studies across 73,000+ sites involving 675,000+ trial patients.


Job Purpose

Responsible for authoring, reviewing, and editing Clinical Study Reports (CSRs), patient narratives, and other medical writing deliverables. Mentors junior writers and ensures compliance with regulatory guidelines and client standards.


Key Responsibilities

Medical Writing & Content Development

  • Compile, write, and edit medical writing deliverables with minimal supervision.

  • Develop/support documents including:

    • Clinical study protocols and amendments

    • Clinical study reports

    • Patient narratives

    • Annual reports

    • Investigator brochures

  • Review statistical analysis plans and TFL (Tables, Figures, Listings) specifications for content, grammar, format, and consistency.

  • Conduct online clinical literature searches as applicable.

  • Adhere to ICH-E3 guidelines, client standards, SOPs, and approved templates.

Collaboration & Mentorship

  • Interact with data management, biostatistics, regulatory, and medical affairs teams to ensure document accuracy.

  • Serve as peer reviewer and address team comments to ensure scientific clarity and consistency.

  • Mentor less experienced medical writers as needed.

Project Management & Compliance

  • Manage assigned projects within budgeted hours.

  • Track timelines, communicate changes, and complete administrative tasks on schedule.

  • Minimal travel required (<25%).


Qualifications & Experience

  • Education: Postgraduate degree (Master/MPharm) or Bachelor’s degree in relevant field.

  • Experience:

    • ≥1 year of narrative experience with postgraduate qualification

    • ≥2 years with graduate qualification

  • Demonstrated proficiency in drafting, reviewing, and editing narratives.

  • Strong knowledge of English grammar, FDA and ICH regulations, and AMA style guide.

  • Familiarity with clinical research principles and ability to interpret and present complex clinical data.

  • Proficiency in MS Word, Excel, PowerPoint, email, and internet.


Core Competencies

  • High degree of independence, professionalism, and team orientation.

  • Effective presentation, proofreading, interpersonal, and leadership skills.

  • Strong attention to detail, accuracy, and quality of outputs.

  • Ability to work collaboratively in cross-functional teams.


Additional Information

  • Responsibilities may evolve; company may assign additional tasks as needed.

  • Equivalent experience, skills, or education may be considered.

  • Compliant with the Americans with Disabilities Act; reasonable accommodations provided.

  • Opportunity to join the Talent Network for future career opportunities.


Summary

The Medical Writer II (CSR Narratives) produces high-quality clinical writing deliverables, including CSRs and patient narratives, while mentoring junior writers, ensuring regulatory compliance, and supporting cross-functional teams.