Job Title: Medical Writer
- Writes and oversees the preparation of clinical study protocols, clinical study reports, Investigator's Brochures, clinical pharmacology sections of US and EU clinical trial applications and marketing applications, and other high-level summary, briefing, and response documents in accordance with international guidelines.
- Performs macroediting of documents for organization, content, structure, and tone, and to ensure documents are consistent, and microediting of documents for punctuation, grammar, sentences, paragraphs, and writing styles.
- Coordinates the review, revision, quality control, quality assurance, electronic publishing, and approval of documents.
- Develops/Maintains standards and processes.
- Follows Company Safety, Health, and Environmental policies and procedures.
- Performs other projects and duties as required/assigned.
- Scientific Background: Clinical pharmacology with experience in Abuse liability document writing preferred.
Functional Knowledge: World-wide government regulations pertaining to drug development and regulatory documents in support of clinical research.
Industry Related Knowledge: Worked independently within an interdisciplinary, global team. Project management experience.
Technical Knowledge: Proficient in the Microsoft Office suite of applications/functionality, and use of electronic document management systems
Language: Excellent English, both written and spoken.
Competencies Ability to manage multiple priorities and work well under time constraints. Writing/document preparation/document organization, communication, collaboration, organizational, cross-function team skills. Data interpretation and summarization. Attention to detail. Ability to plan, write, review, and edit a variety of clinical and scientific regulatory documents and ensure that these documents adhere to applicable regulatory guidelines, and departmental and editorial standards.
- Medical, Dental, and Vision Insurance
- 401K Plan with Company Match
- Life and AD&D Insurance