Principal Medical Writer
Principal Medical Writer
The Principal Medical Writer is responsible for authoring documents, including clinical study reports (CSRs), protocols, investigator’s brochures, publications and other documents. This position is also expected to contribute to higher level submission documents. This position will be responsible for coordinating reviews using industry medical writing standards as well as the completion of key timelines and deliverables. This position will support projects across all phases of clinical development and post-marketing life cycle management.
- Collaborate with cross-functional team members to ensure accurate and timely completion/delivery of high-quality, scientifically-justified documents.
- Responsible for the scientific integrity, quality, accuracy, and regulatory quality assurance of developed content and deliverables.
- Responsible for implementation of medical writing review processes.
- Contribute scientifically at the project and/or study team level.
- Communicate deliverables needed, writing process, and timelines to team members.
- Contribute to the development and standardization of templates and related processes and assist in the development of templates, style guides, and SOPs for writing.
- Maintain expert knowledge of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions.
- Lead comment resolution meetings.
- Learn and apply knowledge of therapeutic area and product to scientific writing projects.
- Develop, maintain, and drive document finalization timelines and coordination of document review.
- Provide editorial or review support for other types of documents as requested. These include, but are not limited to, abstracts, manuscripts, posters, and presentations for scientific meetings and journals.
Candidate Requirements (External)
- Master’s, PhD or PharmD in Life Science disciplines; equivalent combination of education and applicable job experience may be considered.
- Minimum of 10 years experience in oncology in a basic or clinical research environment.
- Minimum of 6 years of progressively responsible medical writing experience in a pharmaceutical, biotechnology, Contract Research Organization (CRO) or related environment.
- Proficiency with Microsoft Office and use of electronic document templates.
- Time management and project management skills are essential.
- Knowledge of FDA guidelines and regulations.
- Experience or background in working within the pharmaceutical industry, awareness of compliance issues and guidelines around medical education and publications.
- Ability to manage multiple projects, solve problems, deliver on commitments and work with multidisciplinary teams.
- Independent, self-starting individual with a demonstrated ability to thrive in smaller, biotech environment is required.
- Strong interpersonal and organizational skills and excellent verbal and written communication skills are required.
- Excellent collaboration skills with strong attention to detail and the ability to multitask and manage complexity.
Send resume and cover letter to firstname.lastname@example.org.