Job Title:
Sr. Medical Writer
Location:
Remote – SRB
Job ID:
25101499
Company Overview:
Syneos Health® is a fully integrated biopharmaceutical solutions organization focused on accelerating customer success. We provide clinical, medical affairs, and commercial expertise to improve patient outcomes and address modern market needs.
Our Clinical Development model prioritizes patients and customers, ensuring efficient and effective delivery of therapies.
Learn more: Syneos Health
Job Summary:
The Sr. Medical Writer serves as the principal medical writer on clinical study or regulatory project teams, providing scientific writing, regulatory guidance, and technical expertise. Responsible for producing and reviewing high-quality, complex regulatory and scientific documents, ensuring clinical data is clearly presented and compliant with applicable regulatory guidelines.
Key Responsibilities:
Lead the development and completion of complex medical writing deliverables for clinical and regulatory projects.
Define document strategy and coordinate medical writing activities with minimal supervision.
Resolve client comments and ensure deliverables meet quality standards.
Prepare documents including but not limited to:
Clinical study protocols & amendments
Clinical study reports (CSRs)
Patient narratives
Investigator brochures
Informed consent forms
Annual reports & plain language summaries
Periodic safety update reports
Clinical development plans
IND, NDA, and eCTD submissions
Journal manuscripts, abstracts, posters, presentations
Ensure adherence to regulatory standards (e.g., ICH E3), company SOPs, client templates, and style guides.
Advise clients and teams on data presentation strategies to meet objectives.
Conduct document and quality reviews; ensure proper source documentation management.
Review statistical analysis plans, tables, figures, and listings for content, format, and consistency.
Perform clinical literature searches while complying with copyright requirements.
Mentor and guide junior medical writers on complex documents.
Contribute to internal processes, standard practices, and capabilities.
Communicate project status, timelines, and budget considerations to leadership.
Represent the medical writing department in cross-functional teams, conferences, and client meetings.
Minimal travel may be required (less than 25%).
Qualifications:
Advanced experience in medical writing, preferably in clinical or regulatory settings.
Expertise in regulatory guidelines, including ICH and FDA requirements.
Strong scientific writing, editing, and communication skills.
Experience mentoring junior medical writers.
Ability to work independently and collaboratively across teams.
Skills & Competencies:
Deep understanding of clinical study design and regulatory documentation.
Proficient in managing multiple projects and meeting deadlines.
Strong analytical, problem-solving, and attention-to-detail skills.
Effective client and team communication.
Additional Information:
Tasks and responsibilities may be adjusted by the company.
Equivalent experience and education may be considered.
Compliance with applicable labor laws, including ADA accommodations, is ensured.
Job Category:
Medical Writing / Scientific Writing / Regulatory Affairs / Clinical Documentation
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Boise |Illinois :
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Frank Scottile Blvd |LA :
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Bangor | Brewer |Maryland :
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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 :
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Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
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Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
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Halle |Schleswig Holstein :
Kiel |Belgium :
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Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
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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 :
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Donegal |China :
China | Quarry Bay |Hubei :
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Hangzhou |Melbourne :
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Ballina | Sydney |Queensland :
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Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
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Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
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Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Mississauga | North York | Richmond Hill | Uxbridge | Australia | Renfrew |Quebec :
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Santiago |Republic of Colombia :
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Croatia |Zagreb :
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Prague |Republic of Egypt :
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Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
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Sweden |Taipei :
Taipei |Williamson :
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