Scientific (Medical) Writing Lead

Biomapas

Remote, Europe

Description

Join our Regulatory Affairs department as a Scientific (Medical) Writing Lead . Position is in any EU country.

Scientific Writing Lead prepares clinical and regulatory documentation as a hands-on medical writer, leads and supports the Scientific Writing team operationally and coordinates scientific writing projects.

Role responsibilities

Act as lead for the Scientific Writing team;
Coach, guide, and support team members;
Plan and coordinate job tasks, define resources and information required for the execution of the tasks;
Serve as the primary point of contact for medium - high complexity Scientific Writing projects;
Act as the lead with respect to content and scientific strategy in complex projects;
Development / review / update of SOPs, Working Instructions, Job Descriptions and etc.;
Write/review/assess a range of scientific documents;
Assess documents for marketing authorisation of medicinal products, clinical studies, other biomedical research to make conclusions and recommendations;
Contribute to the development of regulatory strategy & clinical research program;
Participation and contribution in audits;
Contribute to the preparation of financial proposals, service orders, and agreements;
Contribute to the Regulatory Affairs department budget preparation;
Communicate and co-operate with vendors, consultants, and key experts;
Serve as backup for other team members as required.

Requirements

MSc or higher degree in Medicine, Pharmacy, Public Health or Life Sciences;
PhD degree is preferred but not essential;
At least 5 years experience in medical or scientific writing;
Previous mentoring or line management experience is preferred;
Strong scientific background ;
Fluency in native language and English;
In depth knowledge of clinical development process, regulatory procedures, and relevant industry guidelines;
Good understanding of basic human anatomy and physiology;
Basic knowledge of biostatistics;
Scientific writing competency;
Good knowledge of MS Word, Excel, PowerPoint, Outlook, reference management software, etc.;
Continuous professional learning and development;
Attention to details;
Ability to prioritize and work to deadlines with high quality;
Ability to work independently and within the team.