Principal Medical Writer – Client Embedded

🔥 3 minutes ago

🇷🇸 Serbia – Remote

⏰ Full Time

🔴 Lead

🏥📝 Medical Writer

👻 Ghost score 10%

What it means: the chance that no one is really hiring for this job.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.Why this score:

• Just posted.
• Jobs at this company usually fill in 25 days.
• No salary listed.

Apply Now

Find Similar Remote Jobs

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

• Research, write, and edit clinical study reports and study protocols • Summarize data from clinical studies • Serve as primary author and provide input on complex clinical, scientific, and program-level documents, including IBs, INDs, and MAAs • Provide senior-level review of routine and complex documents • Train and mentor writers and program managers on document preparation, document-development software, document types, regulatory requirements, and therapeutic-area knowledge • Ensure compliance with quality processes and requirements for assigned documents • Develop and review best practices, methods, and techniques as a subject matter expert • Lead process improvement initiatives, including client-specific processes • Potentially serve as backup program manager • Identify and resolve out-of-scope activities • Develop timelines, budgets, forecasts, and contract modifications as needed • Assist business development with client presentations and proposal text review • Attend bid defense meetings and capabilities presentations • Represent the department at project launch, review, and project team meetings • Collaborate with internal and external teams to support effective communication and operational excellence

🎯 Requirements

• Bachelor's degree in a scientific discipline or equivalent and relevant formal academic/vocational qualification required • Advanced degree preferred • At least 8 years' experience in regulatory writing • Experience managing and directing complex medical writing projects • Experience working in the pharmaceutical/CRO industry • Significant knowledge of global, regional, national, and other document development guidelines • In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, or communications • Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills • Excellent project management skills • Advanced interpersonal, oral and written communication, and presentation skills • Excellent negotiation skills • Excellent judgment and a high degree of independence in decision-making and problem-solving • Ability to mentor and lead junior-level staff • Additional qualifications in medical writing (AMWA, EMWA, RAC) advantageous

🏖️ Benefits

• Award-winning learning and development programme • Competitive salary • Extensive benefits package focused on employee health and well-being • Flexible working culture • Work-life balance • Collaborative environment • Opportunities to share expertise and grow professionally and personally

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume