Senior Medical Writer – Vaccine

Job not on LinkedIn

🔥 3 minutes 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

💊 Pharmaceuticals

🧬 Biotechnology

⚕️ Healthcare Insurance

💰 Post-IPO Equity on 2022-03

Pharmaceuticals • Biotechnology • Healthcare Insurance

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

• Is in charge of creating, writing, and coordinating concept documents, protocols, informed consent forms, and clinical study reports according to Sanofi Pasteur document standards, tools, and SOPs. • Is in charge of creating, coordinating, compiling, and editing investigator brochures, updated licensure and renewal documents (clinical overviews, addendum to clinical overviews, CTD updates) according to Sanofi Pasteur standards, tools, and SOPs. • Is in charge of creating, writing, and coordinating CTD clinical summaries and overviews in line with Sanofi Pasteur document standards, coordinating the medical writing CTD activities (interaction with RA and other functions involved), and providing the CTD supportive activities within the medical writing department. • Participates as a member of the clinical team accountable to the Clinical Team Leader for all project issues (role of referent medical writer). • Is involved in the peer-review and QC cross-check of documents produced by the Medical Writing platform and in the review of documents produced by other departments (such as SAP and CRF). • Contributes to the development of document templates and relevant SOPs. • Represents the platform on committees and working groups within Clinical as requested. • Provides mentoring support to less experienced colleagues and new Company staff members if needed. • Provides project management of medical writing deliverables for a trial or project, including negotiating timelines, and identifying and escalating issues to both the clinical team and the local Head of Medical Writing. • Is in charge of supervising subcontracted medical writing activities if needed. May contribute to the updates of templates, SOPs, and other guides for Medical Writing.

🎯 Requirements

• Advanced degree in Life Sciences or related field of study. • 3 or + years of clinical and regulatory medical writing experience within a pharmaceutical company or clinical research organization (CRO). • Fluent English communication skills, verbal and written. • Professional background documenting an excellent understanding of and experience in clinical development including clinical study performance/methodology/basic statistics and/or the regulatory environment. • Demonstrated strong interpersonal, time management and technical writing skills. • Excellent word-processing skills and experience with electronic document templates are required and other relevant applications (eg, Excel, Outlook, EndNote, Read Cube, Please Review).

🏖️ Benefits

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. • Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.