Senior Medical Writer, Promotional Review

🔥 14 hours ago

🏄 California – Remote

🏄 California – Remote

💵 $115k - $125k / year

⏰ Full Time

🟠 Senior

🏥📝 Medical Writer

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

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Thermo Fisher Scientific

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1956

🏥 Healthcare

📦 Logistics

🏭 Manufacturing

Healthcare • Logistics • Manufacturing

Thermo Fisher Scientific is the world leader in serving science, with annual revenue of more than $40 billion. Their mission is to enable customers to make the world healthier, cleaner, and safer by supporting life sciences research, solving complex analytical challenges, increasing laboratory productivity, and improving patient health through diagnostics and the development of life-changing therapies. With a global team, they offer innovative technologies and pharmaceutical services through brands such as Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon, and PPD.

📋 Description

• Serve as primary author for routine documents such as clinical study reports and study protocols • Summarize data from clinical studies • Research, write, or edit complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs • Review routine documents prepared by junior team members • Provide training and mentorship to junior writers and program managers • Support document preparation, software use, document types, regulatory requirements, and therapeutic area knowledge • Ensure compliance with quality processes and requirements for assigned documents • Develop best practices, methods, and techniques for optimal results, including client-specific processes • Assist with program management activities, including timelines, budgets, forecasts, and contract modifications • Identify and resolve out-of-scope activities • Represent the department at project launch, review, and project team meetings • Collaborate with internal and external clients to enable effective communication and operational excellence

🎯 Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification • 5+ years of previous experience providing the knowledge, skills, and abilities to perform the job • Experience working in the pharmaceutical/CRO industry preferred • Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous • Excellent data interpretation and medical writing skills • Grammatical, editorial, and proofreading skills • Strong project management skills • Excellent interpersonal, problem-solving, negotiation, oral and written communication, and presentation skills • Significant knowledge of global, regional, national and other document development guidelines • In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory submissions, or communications • Great judgment and decision-making skills • Excellent computer skills and proficiency with client templates • Good knowledge of document management systems and relevant applications such as Excel and Outlook • Occasional ability to drive to site locations and travel domestically and internationally

🏖️ Benefits

• Variable annual bonus based on company, team, and/or individual performance results • National medical and dental plans • National vision plan • Health incentive programs • Employee assistance and family support programs • Commuter benefits • Tuition reimbursement • At least 120 hours paid time off (PTO) • 10 paid holidays annually • Paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave) • Accident and life insurance • Short- and long-term disability • 401(k) U.S. retirement savings plan • Employees’ Stock Purchase Plan (ESPP) with company stock discount