Principal Medical Writer; Regulatory focus - Sponsor-dedicated - Poland, Belgium

Updated: Yesterday

Location: Amsterdam, NH, Netherlands

Job : -OTHLOC-3528-2DR

Principal Medical Writer (Regulatory focus) – Sponsor-dedicated – Poland, Belgium, Netherlands, Spain

• 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, 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.

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and client authoring standards, as applicable, in adherence to 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 processes 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.

• 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.
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
• Proficient understanding and knowledge of global regulatory requirements 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.

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. 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. The Company likewise complies with the EU Equality Directive in the recruitment and employment of its employees.