Job Title: Senior Medical Writer
Location: Home-Based, Portugal
Job ID: 24003298-PRT975
Company Overview
Syneos Health® is a global biopharmaceutical solutions organization that accelerates customer success. It focuses on translating clinical, medical affairs, and commercial insights into impactful outcomes, with a customer-centered clinical development model. With 29,000 employees in over 110 countries, Syneos Health is dedicated to simplifying processes and innovating as a team to meet the changing demands of the biopharmaceutical industry.
Why Syneos Health
Focus on career development and progression.
A supportive culture where diversity and inclusion thrive.
Opportunities for peer recognition and rewards.
A commitment to employee well-being and a Total Self culture.
Key Responsibilities
Leadership: Mentor and guide less experienced writers on complex projects.
Project Management: Lead and manage medical writing projects, coordinating with various departments.
Document Development:
Clinical study protocols, amendments, and reports.
Patient narratives, clinical development plans, and IND submissions.
Investigator brochures, integrated summary reports, and NDA submissions.
Clinical journal manuscripts, abstracts, and presentations.
Problem Solving: Proactively identify and resolve issues during the writing process.
Review: Examine statistical analysis plans and ensure accuracy in content, format, and grammar.
Collaboration: Interact with teams in data management, biostatistics, regulatory affairs, and medical affairs.
Regulatory Compliance: Adhere to ICH-E3 guidelines and other relevant regulatory standards.
Literature Research: Perform clinical literature searches as applicable.
Budget Management: Work within specified budget limits and communicate any changes.
Qualifications
Education:
Bachelor of Science or Arts degree (preferably in Social Sciences, English, or Communications).
Relevant scientific or medical knowledge/experience.
Experience:
Extensive writing experience in the medical/clinical field.
Knowledge of FDA and ICH regulations and AMA style guide.
Skills:
Proficiency in Word, Excel, PowerPoint, email, and the Internet.
Strong presentation, proofreading, interpersonal, and leadership skills.
Ability to interpret and present clinical data.
Additional Information
Travel: Minimal travel required (less than 25%).
Other Duties: Tasks and responsibilities may evolve as needed, and equivalent experience will be considered.
Legal Compliance: Adheres to employment laws, including ADA and EU Equality Directive.
About Syneos Health's Impact
Worked on 94% of all Novel FDA Approved Drugs and 95% of EMA Authorized Products in the last 5 years.
Managed over 200 studies across 73,000 sites and 675,000+ trial patients.
Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
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Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Halol | Jhagadia | Mehsana | Tarasadi | Vadodara | Vapi |Haryana :
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Ranchi |Karnataka :
B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | 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 :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
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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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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 :
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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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Mexico |South Carolina :
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Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
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Budapest |Istanbul :
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Basel | Zurich |Carlow :
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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 :
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Ballina | Sydney |Queensland :
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Leiden |North Yorkshire :
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Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
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Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Australia | Mississauga | Uxbridge | Richmond Hill | Renfrew | North York |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
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Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
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Tallinn |Chuuk :
North Ostrobothnia :
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Turku |France :
Lyon | Paris |Attica :
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Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Netanya | Tel Aviv | Yavne | Be'Er Sheva |Italy :
Italy |Lombardy :
Rho |Japan :
Japan | Saitama |Tokyo :
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Almaty |Remote Korea :
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Ciudad de México |North Island :
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Warsaw |Remote :
Remote - Middle East | Remote - Africa | Remote - Europe | Switzerland | McFarland | Remote - South America (Latin Americal) | Lenexa | Victoria | Remote | Remote, USA | Melbourne |Bucharest :
Bucharest |Makkah :
Riyadh | King Abdullah Economic City | Najran | Khulais | Rabigh | Jeddah |Nišava District :
Niš |Singapore :
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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 :
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Ho Chi Minh City |