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Principal Medical Writer (Regulatory Focus) - Sponsor-Dedicated - Poland, Belgium, Netherlands,...

hace 2 días

Madrid

Principal Medical Writer (Regulatory focus) – Sponsor‑dedicated – Poland, Belgium, Netherlands, SpainSyneos Health® is a leading fully‑integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.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 deliver – for one another, our customers, and, most importantly, for those in need.Why Syneos HealthWe 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 building an inclusive culture – where you can authentically be yourself. Central to this is our purpose – Driven to Deliver – which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone’s life.We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.Job ResponsibilitiesPrincipal Medical Writer I is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross‑functional project teams with minimal oversight to ensure that clinical documents (e.G., Investigators’ Brochures, Clinical Study Reports, and marketing authorization submission documents) accurately and consistently present key data‑driven clinical messages in accordance with program goals and regulatory requirements.Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. Has a broad understanding of clinical research processes and global regulatory document standards. Mentors less experienced writers. Reports to a Director of Medical Writing or above.Key ResponsibilitiesDevelop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and the client authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.Manage medical writing projects, including developing timelines 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.Participate in cross‑functional process improvement initiatives.Participate in defining and writing standard operating procedures and best practices for efficient preparation of quality documents.Manage internal and contract medical writing resources as required to ensure timely completion of assigned ntor more junior medical writing staff.Minimum Requirements and CompetenciesBachelor’s degree required; advanced degree in a relevant scientific/clinical/regulatory field preferred.At least 5 years of medical writing experience in the biopharmaceutical/CRO industry or comparable experience within clinical or preclinical development.Proficiency in organizing and communicating clinical information with minimal oversight.Strong organizational, time management, and project management skills.Strong verbal, written, and interpersonal communication skills for teamwork.Proficient understanding of global regulatory requirements; knowledge of therapeutic areas desired.Proficient in MS Word; experience with an electronic document management system and templates required.Additional InformationTasks, 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 will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company will determine what constitutes equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. The description 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. 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.

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