Premier Research helps highly innovative biotech and specialty pharma companies transform life-changing ideas into reality. We have positioned ourselves right in the middle of the action, targeting unmet needs in Analgesia, Neuroscience, Oncology, Dermatology, Pediatrics, and Rare Diseases.
We’re looking for a talented and energetic Medical Writer to join our team! This is a very exciting opportunity to join a dynamic and innovative team and grow with a forward-thinking organization that is changing to course of medicine.
Working at Premier Research means being an individual - you will be recognized for what you do and you will truly have an impact. You will be working in a friendly environment with colleagues who are genuinely supportive regardless of location or seniority.
Premier Research is on an exciting journey - there is a true buzz throughout the company, so come and be part of it!
As a Medical Writer with Premier Research, you’ll have the opportunity to write Clinical Study Reports (CSRs), Protocols, Investigator Brochures (IBs), other regulatory documents, manuscripts, and poster, slide, or oral presentations. You’ll work on multiple projects and project teams at one time in collaboration with project managers and sponsors
What you’ll be doing:
- Write, edit, and perform QC reviews for CSRs, protocols, and IBs; write and develop manuscripts and posters for publication
- Write Integrated Summaries of Safety and Efficacy (ISS and ISE), New Drug Applications (NDAs) and other regulatory documents necessary for regulatory submission
- Assist in the review of draft case report forms (CRFs), statistical analysis plans (SAPs), and in blinded data listing reviews prior to database lock and provide feedback to the team
- Create in-text tables and word processing; compile document appendices, attachments, etc.
- Participate in document review meetings with the sponsor to determine the most accurate and appropriate protocol design or interpretation of study results
- Review associate medical writer generated documents and mentor with constructive feedback
- Conduct background research for each assigned project, including literature searches
- Maintain a working knowledge of departmental (SOPs) and (ICH) guidelines
You’ll need this to be considered:
- Bachelor’s degree in the medical sciences, journalism, or English (MS or PhD preferred) along with proven experience in medical/technical writing or clinical research
- Working knowledge of ICH and local regulatory authority drug research and development regulations; FDA Guidance Documents/EU Directives/ISO14155 regulations and/or drug/device development; AMA style guidelines; working knowledge of medical terminology
- Solid understanding of clinical research, regulatory guidance, process of getting a product to market,
- Specific experience writing protocols, ICFs, clinical study reports, and understanding the various regulations which govern those documents
- Skills in table creation, data interpretation, writing for multiple audiences.
- Strong attention-to-detail is a must with analytical skills
- Known for being customer-focused in approach to work and communications with the ability to professionally interact with co-workers, handle remote or virtual work/office environment, and respect global time differences
- Maintains a positive, results orientated work environment; excellent team player, collaborative and able to build an effective team.
- Excellent organizational and time-management skills, able prioritize work to meet deadlines; ability to multitask and work effectively in a fast-paced environment with changing priorities; accountable, dependable and strong commitment.
- Expert in Microsoft Office and Adobe Acrobat; excellent typing skills, ability to use templates, and ability to create and manage large electronic files and documents