Hobson Prior is seeking a Medical Writing/Disclosure Transparency Lead to join a pharmaceutical company based in Amsterdam, Netherlands. This is an exciting opportunity, with the flexibility to work from home 2 days a week. In this position you will be responsible for the development, implementation and maintenance of operations related to the company’s clinical trial disclosure.
- Accountable for make sure that the clinical trial disclosure follows applicable global regulations.
- Responsible for managing the operational activities within the clinical trial disclosure area.
- Responsible for ensuring staff at all levels of the organisation involved in disclosure activities understand and comply with appropriate regulation and are equipped with the knowledge and tools required to do so.
- Delivers pioneering leadership for process improvement and technology change.
- Medical Writing - Planning, management of process and preparation of submission documents including clinical overviews (module 2.5) that meet the corporate objectives and are compliant with relevant ICH, GCP, regulatory and company regulations and standards.
- Responsible for building and maintaining collaborative relationships with clinical disclosure partners (CRO, vendor, alliance partner, etc) to ensure an effective, efficient, productive and professional working relationship.
- Monitor the development of new regulatory guidelines regarding clinical trial transparency.
- Ability to work self-sufficiently and as a team member, across global teams.
- Strong written and verbal communication skills.
- Excellent organisational and time management skills.
- Meticulous eye to detail.
- An undergraduate degree with Honors in pharmacy, biological sciences or related disciplines. (PhD or MD preferred).
- A minimum of 5 years clinical development and/or regulatory affairs experience (preferably both) within the biopharmaceutical industry or a contract research organization.
- Demonstrated the ability to manage several projects simultaneously.
- Knowledge of drug development process; a background in biologicals, pharmaceuticals, and/or therapeutic areas is a plus.
- An excellent understanding of all aspect of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP).
- A strong understanding of international regulatory guidelines pertaining to clinical trial disclosure.
- Excellent understanding of all aspects of ICH-GCP; keen insight on external clinical publication practices and standards (ICMJE, AMA, GPP).
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.