Job Overview
We are seeking an experienced Medical Writer to join our team. As a Medical Writer, you will work with cross-functional teams to facilitate scientific publications and regulatory documents.
The ideal candidate will have a strong background in medical writing, clinical trial process, and regulatory activities.
Responsibilities:
* Plan, write, edit, review, and coordinate the publication of scientific data through peer-reviewed journals and forums and/or regulatory documents.
* Facilitate trial development and product registration.
* Ensure quality checks for accuracy, collate reviewer's comments, adjust content of document as required based on internal/external input, and prepare final version.
* Ensure final documents and supporting quality check documentation (with all signatures where appropriate) are placed in appropriate document management system.
* Build relationships with vendors/alliance partners.
* Maintain and enhance therapeutic area knowledge including disease state and compound for assigned project.
* Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to lead the scientific data disclosure planning, clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.
Requirements:
* PhD is preferred but candidates with Bachelor's Degree will be considered.
* Graduate degree with formal research component or in life sciences.
* Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise).
* Experience in clinical trial process or regulatory activities is preferred.
* Experience writing regulatory or clinical trial documents is preferred.
* Publication experience.
* Demonstrated mastery of written English with experience in medical, scientific or technical writing fields (at least 1 year); professional verbal skills in English.