May include any and/or all of the following job duties:
Works independently to write and edit Clinical Study Protocols, Clinical Study Reports, Investigator's Brochures, Clinical Trial Results postings, IND and NDA Annual Reports, and other clinical or regulatory documents across multiple therapeutic areas as assigned.
Enters study information and results into the clinicaltrials.gov database or other online data repository.
Reviews Statistical Analysis Plans, data tables and listings, and other clinical regulatory documents as needed.
Works with project team to prepare Briefing Documents, Common Technical Document summaries, and other complex clinical regulatory documents as needed.
Assists with the preparation or revision of SOPs, Work Instructions, and document templates.
Assists with training across functional areas for the implementation of new/revised procedures and templates.
Ensures the quality of clinical regulatory documents by maintaining and promoting familiarity with ICH, GCP, and other standards.
Negotiates timelines with Project Management and functional leaders.
Provides QC support for clinical regulatory documents as needed.
Represent Medical Writing on specific functional or cross-functional issues.
Will introduce and /or revise processes where applicable.
KNOWLEDGE, SKILLS, ABILITIES AND PERSONAL CHARACTERISTICS
Knowledge of FDA and International Conference of Harmonization (ICH) Guidelines
Excellent written and communication skills
Strong operational, organizational, presentation, documentation and interpersonal skills
Bachelors Degree in science/health related field
Hematology/Immunology experience preferred but not required
Minimum 4-5 years experience in the pharmaceutical/biotech industry
Please email all CVs to firstname.lastname@example.org