Principal Medical Writer – Anywhere in EU.
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose– built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high– value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
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 Syneos Health easier to work with, but to make us 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 to change 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 are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives – we’re able to create a place where everyone feels like they belong.
The Principal Medical Writer is responsible for the development of clinical documents for submissions to regulatory authorities globally. This is a remote role, which can be based in any EU country.
Provides strategic direction to cross– functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators’ Brochures [IBs], Clinical Study Reports [CSRs], 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.
Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication 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 process(es) needed for the completion of regulatory documents.
Review other documents associated with the assigned project(s) (eg, 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 an efficient preparation of quality documents.
Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
Mentor more junior medical writing staff.
What we’re looking for
- Bachelor’s degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
- Solid clinical medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical development. Specific experience: Seasoned writer able to independently produce clinical documents, including Investigators’ Brochures, Clinical Study Reports, and marketing authorization submission documents.
- Proficiency in organizing and communicating clinical information required with minimal oversight.
- Strong organizational, time management, and project management skills are required.
- Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
- Proficient understanding and knowledge of global regulatory requirements needed and knowledge of
- therapeutic areas in all phases of clinical development desired.
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 the initiative and challenge the status quo with us in a highly competitive and ever– changing environment. Learn more about Syneos Health.
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 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 as 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.
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