Syneos Health एक पूरी तरह एकीकृत बायोफार्मास्युटिकल समाधान संगठन है, जो ग्राहकों को उपचारों को नैदानिक विकास से व्यावसायिक वितरण तक ले जाने में मदद करता है। इसकी टीमें बदलती स्वास्थ्य सेवा आवश्यकताओं को पूरा करने और दुनिया भर में महत्वपूर्ण उपचारों के विकास व लॉन्च में सहायता देने के लिए नैदानिक, चिकित्सा मामलों, वाणिज्यिक, प्रौद्योगिकी और बाज़ार संबंधी अंतर्दृष्टियों को एक साथ लाती हैं।
Senior Medical Writer, FSP
Prepare clinical and regulatory documents for Syneos Health. Lead medical writing across study teams, reviews, and client deliverables.
कनाडा
संयुक्त राज्य
मैसाचुसेट्स$80,600 – $1,75,700 / वर्ष
रिमोटपूर्णकालिकवरिष्ठआवश्यक भाषा: अंग्रेज़ीचिकित्सा लेखकविवरण
- Lead the preparation of clear, accurate medical writing deliverables.
- Manage writing activities for individual studies and coordinate work across departments.
- Resolve client comments.
- Prepare study protocols and amendments, clinical study reports, patient narratives, annual reports, investigator brochures, informed consents, plain language summaries, periodic safety update reports, clinical development plans, IND and NDA submissions, integrated summary reports, eCTD submissions, journal manuscripts, abstracts, posters, and presentations.
- Follow ICH E3 guidelines, company SOPs, client standards, approved templates, authorship requirements, and style and formatting guides.
- Coordinate quality and editorial reviews and maintain source documentation.
- Lead team document reviews and serve as a peer reviewer.
- Review statistical analysis plans and table, figure, and listing specifications.
- Build working relationships with clients and teams in data management, biostatistics, regulatory affairs, and medical affairs.
- Search clinical literature online and follow copyright requirements.
- Identify and propose solutions, escalating issues when appropriate.
- Provide technical support, training, and consultation.
- Mentor and guide less experienced medical writers on complex projects.
- Build expertise in industry topics and regulatory requirements.
- Track budgeted hours and report status and changes to medical writing leadership.
- Complete administrative work and other assigned duties.
आवश्यकताएँ
- Bring 3–5 years of relevant experience in scientific, technical, or medical writing.
- Have experience in the biopharmaceutical, medical device, or contract research organization industry.
- Have a strong grasp of FDA and ICH regulations, other regulatory guidance, and/or good publication practices.
- Have experience preparing relevant document types.
- Demonstrate extensive English grammar knowledge and clear communication skills.
- Be highly familiar with the AMA Manual of Style.
- Be available for minimal travel, potentially under 25%.
लाभ
- Career development and advancement opportunities.
- Supportive, engaged line management.
- Technical and therapeutic area training.
- Peer recognition and a total rewards program.
- An inclusive workplace culture.
- A company car or car allowance.
- Medical, dental, and vision coverage.
- A 401(k) plan with company match.
- Eligibility to participate in the Employee Stock Purchase Plan.
- Eligibility to earn commissions or bonuses based on company and individual performance.
- Flexible paid time off.
- Sick time.
- Reasonable accommodations when appropriate.
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