Principal Medical Writer / Submission Docs / Oncology

Principal Medical Writer - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based Principal Medical Writer - Submission Docs (2.5/2.7.2/2.7.3/2.7.4) - Oncology - Remote Based 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 are continuously looking for ways to simplify and streamline our work to not only make改善 the work experience but also to make us a better workplace. 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:

• We are passionate about developing our people through career development, progression, supportive line management, and technical and therapeutic area training, peer recognition, and a total rewards program.
• We are committed to our Total Self culture – a place where you can authentically be yourself and where we care for our people.
• We continually build the company we all want to work for and our customers want to work with. Diversity of thoughts, backgrounds, cultures, and perspectives enables us to create a place where everyone feels they belong.

Job Responsibilities

• Develop regulatory documents for submission to regulatory agencies globally, including Clinical Study Reports, Clinical Summaries of Efficacy and Safety, and Clinical Overviews, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, while meeting study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (in collaboration with study/project teams as necessary) and communicating with cross‑functional team members to maintain awareness of review cycles and expectations.
• Participate in cross‑functional meetings to provide input regarding medical writing deliverables, timelines, and any processes needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.
• eCTD submission experience preferred.
• This role does not require mentoring junior아요 writers, managing external vendors, or participating in standard operational procedures or other departmental initiatives. Location preferences (EU vs. US) are not a requirement – writers operate only on the global team.

Additional Information Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no abi prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes an equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job. Learn more about Syneos Health at www.syneoshealth.com. Apply tot his job Apply To this Job