Hobson Prior are currently working with a leading world-wide CRO who are looking for a Medical Writer to work remotely on a contract basis. This role will be accountable to critically evaluate, analyse, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias.

Job Responsibilities:

• You will be responsible to write and edit clinical development documents (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 complete writing assignments in a timely manner.
• Maintain timelines and workflow of writing assignments.
• Practice good internal and external customer service.
• Highly proficient with styles of writing for various regulatory documents.
• Expert proficiency with client templates & style guides.
• Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects.
• Contribute substantially to, or manages, production of interpretive guides.
• You will take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary.
• Mentor medical writers and other members of the project team who are involved in the writing process.

Key Skills:

• Strong writing skills are a must.
• Excellent organizational skills and the ability to multi-task are essential prerequisites.
• Proficient with MS Word, Excel, PowerPoint, and related word processing tools.

Requirements:

• Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline.
• A minimum of 3 years previous experience in the pharmaceutical industry.
• A minimum of 3-5 years of industry regulatory writing and clinical medical writing experience is a must.
• You will have an understanding of clinical data.
• Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus.
• Experience being a project lead or managing a project team.
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Substantial clinical study protocol experience, as lead author is required.
• Prior 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.