Senior Medical Writer

🔥 8 minutes ago

🇮🇳 India – Remote

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

👻 Ghost score 10%

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Syneos Health

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

💼 Consulting

📦 Logistics

Healthcare • Consulting • Logistics

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. They translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities. By utilizing advanced technologies and insights, Syneos Health collaborates with clients to speed the delivery of important therapies to patients worldwide, offering services that span the entire clinical-to-commercial spectrum.

📋 Description

• Lead clear and accurate completion of medical writing deliverables • Manage medical writing activities for individual studies and coordinate across departments • Lead resolution of client comments • Complete clinical study protocols, protocol amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND submissions, integrated summary reports, NDA and eCTD submissions, journal manuscripts, abstracts, posters, and presentations • Follow ICH E3 guidelines, company SOPs, client standards, templates, authorship requirements, and style guides • Coordinate quality and editorial reviews and manage source documentation • Lead team document reviews and perform peer reviews • Review statistical analysis plans and table/figure/listing specifications • Collaborate with clients and data management, biostatistics, regulatory affairs, and medical affairs teams • Perform online clinical literature searches and comply with copyright requirements • Identify and resolve issues, escalating as appropriate • Provide technical support, training, and consultation • Contribute to internal materials, presentations, processes, standards, and capabilities • Mentor and lead less experienced medical writers on complex projects • Develop expertise in industry topics and regulatory requirements • Complete administrative tasks and other assigned duties

🎯 Requirements

• Minimum 4 to 5 years of experience in medical writing • 3–5 years of relevant experience in science, technical, or medical writing • Experience working in the biopharmaceutical, device, or contract research organization industry • Experience working with PK/PD studies, CSR, IB, ICF, and protocols • Experience with Phase II/Phase III studies and readiness to work in Early Phase • Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices • Experience writing relevant document types • Extensive knowledge of English grammar and ability to communicate clearly • Strong familiarity with AMA Manual of Style • Ability to work within budgeted hours and communicate status and changes to medical writing leadership • Equivalent experience, skills, and/or education will also be considered

🏖️ Benefits

• Career development and progression • Supportive and engaged line management • Technical and therapeutic area training • Peer recognition and total rewards program • Inclusive culture • Minimal travel may be required (less than 25%)