Hobson Prior are working with an award-winning, data-focused CRO who are looking for an Senior Medical Writer to join them remotely on a permanent basis.

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

Job Responsibilities:

• You will oversee given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary.
• You will write and edit clinical development documents, including but not limited to, clinical protocols, investigator's brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials and publications to medical journals.
• You will evaluate, analyse, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias.
• To complete writing assignments promptly.
• Support timelines and workflow of writing assignments.
• You will contribute substantially to, or manages, production of interpretive guides.
• To be experienced with styles of writing for several regulatory documents.
• You will contact directly and self-sufficiently with client to coordinate all parts of projects; excellent communicator skills for projects.
• You will be working with client templates & style guides.
• To guide medical writers and other members of the project team who are involved in the writing process.

Key Skills:

• Excellent organizational skills and the ability to multi-task are essential prerequisites.
• Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools.

Requirements:

• To be educated at a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline.
• Previously have at least 3 years' experience in the pharmaceutical industry.
• Demonstrated in leading and managing teams while authoring regulatory documents with aggressive timelines.
• Previous experience in regulatory submissions presented to regulatory authorities a plus.
• To have at least 3-5 years of industry regulatory writing and clinical medical writing experience.
• Previous experience in substantial Oncology.
• Previous experience in substantial clinical study protocol as lead author, required.
• Excellent knowledge of federal regulations, Good Clinical Practices, and ICH guidelines a plus.
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines.

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.