Hobson Prior are looking for an Associate Director - Principle Medical Writer to join a biopharmaceutical research organisation who specialize in oncology product development and pioneering medicines that are used all over the world. This position is responsible for the development of clinical documents for submissions to regulatory authorities globally.

Job Responsibilities:

• Lead, manage, and coordinate all internal and external writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally.
• Oversee and manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Administrate as appropriate, the receipt, collation, and incorporation of review comments needed for the completion of regulatory documents.
• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and AMA Medical Writing styles, as applicable, in adherence with study/project timelines and corporate objectives.
• Actively participate in study and/or project team meetings to provide input regarding medical writing deliverables, timelines, and any processes needed for the completion of regulatory documents.
• Lead or participate in defining and writing standard operating procedures and working practices which will allow the effective and efficient preparation of quality.
• Lead or participate in cross-functional process improvement initiatives.
• Mentor more junior medical writing staff.

Key Skills:

• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
• Proficiency in organizing and communicating clinical information necessary.
• Strong communications, organizational, time management, and project management skills are required.
• Proficient in MS Word and experience with template systems (eg, StartingPoint).

Requirements:

• A Bachelor's degree in a life science discipline, with Master's degree in life science discipline preferred.
• A minimum of 6 years writing experience in the biopharmaceutical/CRO industry required.
• Proficient understanding and knowledge of domestic and international regulatory requirements required and knowledge of therapeutic areas in all phases of clinical development desired.
• Experience with an electronic document management system (eg, MasterControl, Documentum) and use of templates preferred.

Apply now:

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.