Job Title:
Senior Medical Writer – Remote (India)
Job Summary:
Parexel is hiring an experienced Senior Medical Writer to join its global team. This remote position requires excellent scientific communication skills, strong pharmacovigilance knowledge, and the ability to author and manage various clinical research and regulatory documents. The role offers a chance to work on innovative drug development projects and signal management activities while collaborating with international cross-functional teams.
Key Responsibilities:
Author signal management reports including Validations, SERs, and responses to Health Authority requests.
Perform end-to-end signal management: tracking, assessment, review meetings, and presentation in collaboration with GSO.
Conduct qualitative and quantitative signal detection from databases, literature, and regulatory sources.
Provide safety input across early and late-phase development activities.
Maintain thorough knowledge of drug safety profiles, labeling documents, global regulations, and SOPs.
Manage and ensure compliance with regulatory and internal timelines for adverse event reporting.
Author clinical narratives and contribute to post-marketing safety risk management.
Conduct and attend internal training; mentor new hires as needed.
Support benefit-risk assessments and safety-related regulatory activities.
Required Skills & Qualifications:
Bachelor’s or higher degree in Life Sciences, Pharmacy, Microbiology, Biochemistry, Biotechnology, Biophysics, Medicine, Dentistry, Physiotherapy, Experimental Medicine, or Nursing.
Prior experience in Medical Writing, Pharmacovigilance, or Regulatory Affairs preferred.
Strong knowledge of medical terminology and global drug safety regulations.
Excellent written and verbal communication skills.
Proficient in MS Office Suite and web-based applications.
Ability to critically analyze data and summarize medical text accurately.
Excellent organizational, prioritization, and problem-solving skills.
Team-oriented with a client-focused approach.
Capability to manage multiple tasks with attention to detail.
Perks & Benefits:
Competitive compensation package.
Fully remote working arrangement.
Professional development through mentorship, training, and career advancement programs.
Inclusive, collaborative, and supportive work culture.
Opportunities to contribute to global drug development impacting patient care.
Company Description:
Parexel is a leading global clinical research organization providing comprehensive drug development and regulatory consulting services. With a strong presence in the life sciences industry, Parexel delivers tailored solutions to drive patient-centered healthcare innovations worldwide.
Work Mode:
Remote (India – including locations such as Hyderabad, Bengaluru)
Salary Range:
Not Specified (Competitive package)
Call-to-Action:
Ready to make a meaningful impact in clinical research and medical writing? Apply now to join Parexel's global team of experts and advance your career in life sciences!
Experience Required:
Relevant experience in Regulatory Affairs, Pharmacovigilance, or Medical Writing (years not specifically mentioned but prior experience is desirable).
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Czech Republic | Mangaluru | Mysore | Udupi |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Jalgaon | Kolhapur | Kurkumbh | Kurla | Mumbai | Nagpur | Nashik | Navi Mumbai | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli |Odisha :
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Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore |Uttar Pradesh :
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Dehradun | Halifax | Nainital | Rishikesh | Roorkee |West Bengal :
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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Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | St. Helena | Stanford | Stanton | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |Colorado :
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Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |D.C :
Washington |Delaware :
Wilmington |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Georgia :
Atlanta | Augusta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
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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 :
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 :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |North Carolina :
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Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |North Dakota :
Dickinson |northeastern :
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Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Portugal :
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Wavre |BULGARIA :
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Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
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Donegal |China :
China | Quarry Bay |Hubei :
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Dalian |Republic of China :
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Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
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Leiden |North Yorkshire :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
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Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
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Renfrew | Mississauga | Australia | Richmond Hill | Uxbridge | North York |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
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Turku |France :
Lyon | Paris |Attica :
Athens | Koropi |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Yavne | Netanya | Kfar Saba | Be'Er Sheva | Tel Aviv |Italy :
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Rho |Japan :
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Remote - Africa | Victoria | Switzerland | Zaragoza | Remote - Europe | Castlebar | Bishop | Green Way | French | Remote, USA | Riga | Remote | Lenexa | Remote - South America (Latin Americal) | Remote - Middle East | Melbourne | Leinster | McFarland |Bucharest :
Bucharest |Makkah :
Najran | King Abdullah Economic City | Jeddah | Khulais | Riyadh | Rabigh |Nišava District :
Niš |Singapore :
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Sao paulo | Brazil |South America :
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Barcelona |Madrid :
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Sweden |Taipei :
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Kyiv |Dubai :
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Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |