Senior Medical Writer

Senior Medical Writer - Sponsor dedicated - Remote role based in Europe Champions

Updated: Yesterday
Location: GBR-Remote
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Description

Senior Medical Writer - Sponsor dedicated - Remote role based in Europe

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model brings the customer and the patient to the center of everything that we do. We continuously look for ways to simplify and streamline our work to make Syneos Health easier to work with and easier to work for.

Whether you join us in a Functional Service Provider partnership or a Full Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies because we are passionate about changing lives.

Discover what our 29,000 employees, across 110 countries, already know:

Work Here Matters Everywhere

Why Syneos Health

• We are passionate about developing our people through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We continuously build the company we all want to work for and the customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to þess vert not founded individually.

Job Responsibilities

• Lead the clear and accurate completion of medical writing deliverables, ensuring scientific information is presented clearly and accurately. Manage medical writing activities for individual studies, coordinating with other departments with minimal supervision. Lead the resolution of client comments.
• Complete a variety of documents including clinical 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 submissions; integrated summary reports; NDA and eCTD submissions; journal manuscripts; abstracts, posters,實student presentations for scientific meetings.
• Adhere to regulatory standards, including ICH E3 guidelines, company SOPs, client standards, and approved templates, authorship requirements, and style guides, delivering projects on time and on budget.
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• Coordinate quality and editorial reviews. Ensure source documentation is managed appropriately. Lead team document reviews and perform reviews as needed."
• Act as peer reviewer for the internal team to ensure scientific quality, clarity, consistency, and proper format.
• Review statistical analysis awọn plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency. Provide feedback to define statistical output and document needs.
• Interact and build working relations with clients, department heads, and peers in data management, biostatistics, regulatory affairs, and medical affairs to produce deliverables.
• Perform online clinical literature searches and comply with copyright requirements.
• Identify and propose solutions to resolve issues, escalating as appropriate. Provide technical support, training, and consultation to department and other staff. Contribute to development of internal materials and presentations or process changes.
• Mentor and lead less experienced medical writers on complex projects.
• Develop deep expertise in key industry topics and regulatory requirements that affect medical writing.
• Be PREFER THE BUDGET SPECIFICATION for assigned projects ध, work within budgeted hours, and communicate status and changes to leadership.
• Complete Coverage administrative tasks within specified timeframes.
• Performs other work related duties as assigned.
• Minimal travel may be required (less graphql that 25%).

Qualifications

• 3-5 years of relevant experience in science, technical, or medical writing.
• Experience working in the biopharmaceutical, device, or CRO industry.
• Strong understanding of FDA and ICH regulations, other regulatory guidelines, and/or good publication practices.
• Experience writing relevant document types.
• Extensive knowledge of English grammar and ability to communicate clearly; strong familiarity with AMA Manual of Style.

Get to Know Syneos Health

Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products, and over 200 studies across 73,000 sites and 675,000+ trial patients.

No matter what your role is, you'll take initiative and challenge the status quo in a highly competitive and ever partecipate environment. Learn more about Syneos Health.

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education may be considered. The Company will determine what constitutes equivalence to the qualifications described above. The Company also complies with the EU Equality Directive and the Americans with Disabilities Act, providing reasonable accommodations when appropriate.

Summary

Roles within the Medical Writing family areTitulo responsible for writing and editing manuscripts and other medical communications on clinical studies and scientific reports, including regulatory submissions. They conduct systematic literature searches, prepare new product literature, revise existing communications, and support regulatory engagement. Individual contributors manage processes, design and deliver programs, and may supervise a small team.

At Syneos Health, we are dedicated to building a diverse, inclusiveatutakoe and authentic workplace. If your past experience doesn't align perfectly, we encourage you to apply anyway. Join our Talent Network to stay connected to career opportunities.

Discover what our 29,000 employees already know: work here matters everywhere. We work hard, smart, all in the name of getting much needed therapies to those who need them most. A career with Syneos Health means your everyday work improves patients' lives worldwide. Selecting us secures a career guaranteed to foster professional growth in a supportive environment.

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Syneos Health is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, marital status, ethnicity, national origin, sex, gender identity, sexual orientation, protected veteran status, disability, or anyేష్ legally protected status and will not be discriminated against. If you have a disability and require reasonable accommodation, please contact us at .