Instagram
youtube
Facebook

Sr Medical Writer /Medical Writer 2 (Clinical Trial Transparency)

0-2 years
Not Disclosed
10 Feb. 11, 2025
Job Description
Job Type: Full Time Education: BA/B.Sc./M.Sc./B.Pharm/M.Pharm/Life science 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

Here’s a structured rewrite with a unique slug at the end:


Senior Medical Writer (Clinical Trial Transparency) – Job ID: 25001397-IND501

Location: India-Asia Pacific – IND-Gurugram-DLF Downtown
Updated: February 6, 2025

About Syneos Health

Syneos Health® is a fully integrated biopharmaceutical solutions organization dedicated to accelerating customer success. Our Clinical Development model places the customer and patient at the core, fostering collaboration to drive innovation and efficiency in delivering life-changing therapies.

With 29,000 employees across 110 countries, we embrace a Total Self culture, promoting career growth, diversity of thought, and an inclusive work environment where everyone belongs.

Why Join Syneos Health?

  • Career development, training, and progression opportunities.
  • Supportive management and peer recognition programs.
  • Exposure to a wide range of therapeutic areas and global projects.
  • Competitive total rewards program.

Job Responsibilities

  • Lead and mentor junior medical writers on complex projects.
  • Manage medical writing activities for assigned studies, ensuring coordination across departments.
  • Develop and support key regulatory and clinical documents, including:
    • Clinical study protocols & amendments
    • Clinical study reports
    • Patient narratives
    • Clinical development plans
    • IND submissions & annual reports
    • NDA and (e)CTD submissions
    • Investigator brochures
    • Clinical manuscripts, abstracts, and presentations
  • Identify and resolve challenges in the writing process, escalating when needed.
  • Review statistical analysis plans for accuracy, grammar, and consistency.
  • Act as a liaison between medical writing, data management, biostatistics, regulatory, and medical affairs teams.
  • Provide peer reviews for clarity, accuracy, and regulatory compliance.
  • Conduct online literature searches and stay updated on industry regulations.
  • Ensure projects are delivered on-time and on-budget while adhering to ICH-E3 guidelines, FDA/EMA regulations, and company SOPs.
  • Manage project budgets and communicate necessary adjustments.
  • Complete administrative tasks within designated timeframes.

Qualifications & Skills

  • Bachelor’s degree in Science or relevant writing experience (preferred: English, Social Sciences, or Communications with medical/scientific knowledge).
  • Strong command of English grammar and familiarity with AMA style guide, FDA, and ICH regulations.
  • Proven ability to interpret and present complex clinical data with minimal supervision.
  • Proficiency in Microsoft Word, Excel, PowerPoint, email, and internet research.
  • Effective presentation, proofreading, and leadership skills with a team-oriented approach.

Additional Information

  • Minimal travel required (less than 25%).
  • Tasks and responsibilities are subject to change at the company’s discretion.
  • Syneos Health complies with global employment regulations, including the EU Equality Directive and Americans with Disabilities Act (ADA) for reasonable accommodations.

 

Latest Jobs

Coder Inpatient

Omega Healthcare Management Services
United States

Coder Outpatient

Omega Healthcare Management Services
United States

Coder Physician

Omega Healthcare Management Services
United States

Coder Er

Omega Healthcare Management Services
United States

Quality Control Analyst - Ar

Omega Healthcare Management Services
Tiruchirappalli

Process Coach - Coding

Omega Healthcare Management Services
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 B.G Nagara Baddi Ballina Ballydine Baltimore Banasthali Bangalore Bangkok Bangor Barcelona Baroda Barrow Basel Basking Ridge Batavia Bathinda Baton Rouge Bavaria Bayreuth Be'Er Sheva Beijing Bel Air Bela Belgaum Belgium Belgrade Bellevue Bend Bengaluru Berkeley Berlin Bethel Bethlehem 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 Dún Laoghaire Dunboyne Dunellen Durham Dusseldorf East Brunswick Eden Prairie Edgewood Edison El Monte El Paso El Segundo Elkridge 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 Fort Worth Fortuna Foster City France Frank Scottile Blvd Frankfurt Franklin 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 Hà Nội Haarlem Hackensack Hajipur Halifax Halle Halol Hamburg Hamilton Hammond Hangzhou Hannover Hanoi 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. Minnesota Minnetonka Mississauga Mitte Moga Mohali Monmouth Junction Monroe Montgomery Montreal Montville Morgan Hill Morningside Heights Morrisville Mount Arlington Mount Vernon Mountain View Mt. Pleasant Mukundapur Mumbai Munich Munster Mysore Nagercoil Nagpur Nainital Nairobi Najran Naperville Naples Narsapur Nashik Nashville Navi Mumbai Nebraska City Nedlands Nellore Netanya Netherlands Nevada New Brunswick New Delhi New Hampshire New Haven New Jersy New Orleans New York New Zealand Newark Newtown Niš Noida Norridge North Carolina North Miami Beach North Richland Hills North York Norway NOrway Norwood Novato Nutley Oakland Oeiras OH Oklahoma City Ooty Orange Oregoina Orlando Osaka Otemachi Oulu oxford Pacheco Palo Alto PAN-India Panaji Panchkula Paramus Paris Park City Park RIdge Parsippany Pasadena Passaic Paterson Patiala Patna Peapack-Gladstone Pearl River Pembroke Pines Peridot Peru Phagwara Philadelphia Philippines Phoenix Piedmont Pilani Pine Brook Pirbright Piscataway Township Pithampur Pittsburgh Plainsboro Plano Plantation Pleasant Prairie Pleasanton Plymouth Meeting Poland Pomona Pondicherry (Puducherry) Port St. Lucie Portage Portland Portugal Pottstown Poughkeepsie Prague Prayagraj Princeton Junction Pudupakkam Pullman Pune Pune city Pydibimavaram Quarry Bay Queensland Rabigh Radnor Rahway Raipur Rajpura Raleigh Ranchi Rangareddy Rangpo Raritan Redding Redwood City Reedsport Regensburg Remote Remote - Africa Remote - Europe Remote - Middle East Remote - South America (Latin Americal) Remote Australia Remote Korea Remote, USA Renfrew Rensselaer Rhinebeck Rho Richardson Richmond Hill Riga Ringaskiddy Rishikesh Riverside Riyadh Rockland Rockville Rocky Mount Rohtak Romania Rome Roorkee Roseburg Roseville Rostock Round Lake Rourkela Rueil-Malmaison Runcorn Saarbrucken Sacramento Saint Petersburg Saitama Salem Salisbury Salt Lake City San Antonio San Bernardino San Carlos San Diego San Francisco San Gabriel San Jose San Juan San Mateo San Rafael Sanford Santa Clara Santa Cruz Santa Fe Santa Monica Santiago Sao paulo Sarajevo Sarasota Satyamev Scottsdale Seattle Seguin Sellersville Seoul Serbia Shanghai Shi Sheffield Shelbyville Sherwood Shirpur Shivalik Shreveport Siliguri Simi Valley Singapore Sitka Slovakia Slovenia Sofia Solan Soledad Somerset Somerville South Africa South Plainfield South San Francisco South Windsor South Yarra Southampton Southfield Spain Sparta Spring House Springfield Springville Srivilliputtur St. Helena St. Louis St.Paul Stamford Stanford Stanton Stevenage Stirling Stockton Storrs Stuart Stuttgart Summit Sunnyvale Surabaya Surprise Sweden Switzerland Swords Sydney Sylmar Syracuse Tacoma Taipei Tallahassee Tallinn Tampa Tandalja Tarapur Tarasadi Tartu Tel Aviv Temecula Tempe Texas Thailand Thane Thiruvananthapuram Thousand Oaks Tiruchirappalli Tirupathi Titusville Tokyo Tonopah Tonopsh Towson Trenton Trichy Trivandrum Tubingen Tucson Tucumcari Tulsa Turkey Turku Tuscaloosa Tyler Udaipur Udupi Ujjain Ulm United Kingdom United States Upper Marlboro Utica Uxbridge Vadodara Valencia Vallejo Vancouver Vapi Varanasi Vedant Vellore Venica Verna Victoria Vienna Vietnam Vijayawada Vikhroli Virginia Visakhapatnam Waco Warren Grove Warsaw Washington Waterford Watertown Waukesha Wausau Wavre Waynesville Welwyn West Chester West Hartford West Lafayette West Orange West Palm Beach West Sacramento West Valley City Westfield Westminster Wharton Whippany White Plains Whitesboro Whittier Willits Wilmington Winston-Salem Winter Haven Witney Woodburn Woonsocket Wrangell Wuhan Wurzburg Wyomissing Xzagreb Yavne Yerawada Yogyakarta Yuma Zagreb Zaragoza Zaventem Zurich

Lead - Delivery Quality

Omega Healthcare Management Services
Chennai

Process Coach - Coding

Omega Healthcare Management Services
Hyderabad

Senior Medical Writer

Thermo Fisher Scientific
Remote

Senior Icf Medical Writing Project Manager

Thermo Fisher Scientific
Remote