Develop 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 (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.
Minimum Requirements and Competencies:
Bachelor'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 required or comparable experience within clinical or preclinical development.
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.
Proficient in MS Word. Experience with an electronic document management system and templates is required.
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Benefits
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Additional Information
Principal Medical Writer (Regulatory focus) - Sponsor-dedicated - Poland, Belgium, Netherlands, Spain
Syneos 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.
Discover what your 25,000 future colleagues already know:
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 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 Responsibilities
Job Summary:
The Principal 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 (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.
Mentors less experienced writers.
Reports to a Director of Medical Writing or above.
Syneos Health · Esp-remote (madrid)