Senior Medical Writer – Vaccine

🕒 3 days ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

💵 $122.3k - $176.6k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

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Sanofi

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 2004

🏥 Healthcare

🏭 Manufacturing

📦 Logistics

💰 Post-IPO Equity on 2022-03

Healthcare • Manufacturing • Logistics

Sanofi is a global healthcare company focused on pharmaceutical innovations and improving people's lives through advancements in science. The company is deeply engaged in research and development across several medical fields, including immunology, neurology, oncology, rare diseases, and vaccines. Sanofi is also dedicated to consumer healthcare, with efforts to enhance physical and mental wellness, allergy care, and treatments for cough, cold, and flu. In addition, Sanofi employs artificial intelligence in its research efforts and emphasizes environmental sustainability, diversity, and inclusion as part of its social impact agenda. With a strong commitment to transforming healthcare for vulnerable communities and leading scientific collaborations worldwide, Sanofi plays a significant role in the pharmaceutical and healthcare industries.

📋 Description

• Create, write, and coordinate concept documents, protocols, informed consent forms, and clinical study reports • Create, coordinate, compile, and edit investigator brochures and updated licensure and renewal documents • Create, write, and coordinate CTD clinical summaries and overviews • Coordinate medical writing CTD activities with Regulatory Affairs and other functions • Provide CTD support within the medical writing department • Participate in clinical teams as the referent medical writer and remain accountable to the Clinical Team Leader for project issues • Conduct peer review and QC cross-checks of medical writing documents • Review documents produced by other departments, such as SAP and CRF • Contribute to document templates and relevant SOP development and updates • Represent the Medical Writing platform on Clinical committees and working groups • Mentor less experienced colleagues and new company staff members • Manage medical writing deliverables, negotiate timelines, and identify and escalate issues • Supervise subcontracted medical writing activities when needed • Collaborate closely with clinical team functions to coordinate trial-document writing

🎯 Requirements

• Advanced degree in Life Sciences or related field of study • 3 or more years of clinical and regulatory medical writing experience within a pharmaceutical company or CRO • Fluent English communication skills, verbal and written • Understanding and experience in clinical development, including clinical study performance, methodology, basic statistics, and/or the regulatory environment • Strong interpersonal, time management, and technical writing skills • Excellent word-processing skills • Experience with electronic document templates • Experience with relevant applications such as Excel, Outlook, EndNote, ReadCube, and Please Review

🏖️ Benefits

• Health and wellbeing benefits • High-quality healthcare • Prevention and wellness programs • At least 14 weeks' gender-neutral parental leave • Opportunities for career growth through promotion or lateral moves • Mentoring • International mobility programs • Company employee benefit programs • Supportive, future-focused team • Opportunities to work on AI-driven research, smart manufacturing, and mRNA platforms