.Single Sponsor Principal/Sr Medical Writer - Spain, Poland, Ireland, Netherlands, France, UK, Switzerland, Belgium, Italy, US and Canada.
Must have lead submissions experience.
Updated: December 12, 2024Location: Spain-Europe - ESP-Home-Based (Madrid)Job ID: 24006479 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 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.
Job responsibilities Mentors and leads less experienced medical writers on complex projects, as necessary.
Acts as lead for assigned writing projects and submissions.
Manages medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision.
Develops or supports a variety of documents that include, but not limited to:Clinical study protocols and clinical protocol amendments; Clinical studyreports; Patient narratives; Clinical development plans; IND submissions and annual reports; Integrated summary reports; NDA and (e)CTDsubmissions; Investigator brochures, as well as; Clinical journal manuscripts, clinical journal abstracts, and client presentations.
Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or escalation as appropriate.
Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.
Interacts with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.
Serves as peer reviewer on internal review team providing review comments on draft and final documents.
Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.
Performs on-line clinical literature searches, as applicable.
Maintains familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing