Medical Writer

ProClinical is advertising a vacancy for a Medical Writer position with a leading biotechnology company. Based in Pennsylvania, this is an exciting opportunity to work with an internationally renowned company and support their innovative impact on the healthcare field.

Job Responsibilities:

• Serving as Medical Writing Lead for designated TA and working closely with the Clinical Leads, Clinical Scientists, other Clinical team members, and Submission teams to gather forecasting and budgeting information needs (timelines, projects, documents) for medical writing deliverables in Global Branded R&D.
• Reviewing documents as Medical Writing Lead for programs within a designated TA(s).
• Adhering to Company medical writing systems and standards.
• Preparing high-quality clinical documents, including clinical study reports, briefing books, clinical protocols, and integrated summaries for regulatory submissions.
• Performing the Medical Writing review of selected documents from staff, contractors, or CROs with a 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.
• Ensuring quality and adherence to established timelines for all Medical Writing deliverables in the designated TA
• Acting as a subject matter expert on clinical study teams or submission teams and working in collaboration with multiple cross-functional areas.
• Planning assignments and evaluating of deliverables from contractors or other third-party vendors for medical writing deliverables.
• Carrying out and evaluating literature research.
• Maintaining scientific and clinical accuracy of all deliverables.

Skills and Requirements:

• Master's Degree, other advanced degree, or equivalent experience required; PhD preferred.
• At least 8 years of medical writing experience required in clinical drug development in various therapeutic areas, or equivalent experience in academia or industry.
• Licensure/Credential: RPh or RN is a plus.
• Demonstrable experience as a writer of clinical study documents and global regulatory submissions and as a manager of medical writing projects.
• An understanding of clinical drug development, clinical trials, and global regulatory submission regulations is desired.
• Knowledge of clinical operations, health sciences and biostatistics.
• Demonstrable multitasking, project management, and execution skills.
• Good interpersonal skills, including communication, presentation, persuasion, and influence.
• Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
• Proficiency with computer skills, such as MS Office.

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.

In case you have difficulty in applying or if you have any questions, please contact Sarah Beshara at + 267-477-3355 or upload your CV on our website - www.proclinical.com.

A full job description is available on request.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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