Principal Medical Writer (remote-based)

Hobson Prior has partnered with a global pharmaceutical organisation who are driven to help improve and prolong life. Our client is seeking a Principal Medical Writer to join them on a permanent basis where you will be working from home in Europe.

Please note that to be considered for this role you must have the right to work in this location.

Key Responsibilities:

• You will be responsible for quality and adherence to established timelines for all Medical Writing deliverables in the designated TA or Phase.
• As Medical Writer you will oversee the work of vendors supporting program deliverables.
• You will mentor writers.
• Performs the Medical Writing review of selected documents from staff, contractors, or CROs, with focus on adherence to business objectives and company standards, as well as organization of content, clarity of text and tables, overall consistency, and appropriate use of English language/grammar.
• Acting as subject matter expert representing Medical Writing on cross-functional teams.
• Leads the Medical Writing effort for global program(s) not at a major filing stage, or for a certain Phase across programs (i.e., Phase 1 or Phase IV), or at a regional/local level.
• Independently prepares or oversees the preparation of clinical and regulatory documents such as Protocols, Clinical Study Reports, Briefing Books, Investigator Brochures, and Clinical Summary documents.
• Estimates Medical Writing resource demands for the program(s) he/she supports.
• May support submissions for market approval under the guidance of a Senior Principal Writer/Associate Director.
• Represents department on clinical teams; leads document-related meetings, reviews statistical analysis plans.
• Attends governance meetings (e.g., TARBs/ICSC) for Protocol discussions.
• Performs other duties as assigned.

Key Skills:

• Strong organisational skills.
• Exemplary time and priority management; ability to work collaboratively and efficiently under pressure.
• Strong presentation skills and adapting to a variety of audiences.
• Excellent communication skills (verbal, written and listening) with the ability to interpret and summarise complex data.

Requirements:

• The ideal candidate will require a minimum requirement of a bachelor's degree in a scientific or writing discipline; Master's Degree or Ph.D. preferred.
• 5-8+ years related experience in a medical or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge.
• Ability to lead discussions on document strategy for less complex programs or country specific documents.
• Ability to coordinate vendor resources for filings (IND/IMPD, briefing books, etc.) including country-specific submissions for market approval or label extension.
• Thorough knowledge of the drug development process with an understanding of strategy for regulatory submissions.
• Ability to maintain familiarity with current industry practices, regualtory requirements, and guidelines that effect Medical Writing.
• Shows innovation and ability to implement change.
• Demonstrated ability to understand and represent data clearly in written text.
• Acts ethically, ensures quality, and creates customer value.
• Technical expertise in Microsoft Office suite, MW Word templates, Adobe Acrobat, document management systems, and familiarity with SharePoint and concepts of structured content management.
• Fluent in English (oral and written).
• Ability to travel.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" 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.