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Medical Writer- ImClone Systems- Bridgewater, NJ #412466
Permanent position, candidates must live within commuting distance of Bridgewater, NJ 08807
Contact erin.barraco@imclone.com
GENERAL SUMMARY:
Provides a leadership role within the Medical Information department by independently planning, developing, reviewing, and coordinating medical writing activities. Oversees the completion of assigned data presentations utilizing clinical/medical data/information. Interacts with other departments to provide the clinical/medical data/information necessary for the timely completion of their work.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Writes, and edits, as necessary, clinical protocols/amendments, annual reports to regulatory authorities, clinical study reports, regulatory documents (eg, clinical sections of an IND, dossiers, or a BLA/NDA), ad hoc clinical reports, publications, and related documents.
2. Writes, and edits, as necessary, departmental Standard Operating Procedures (SOPs).
3. Assists with the integration of clinical trial data/information into concise and uniform reports for journal submission or non-routine submission to regulatory authorities.
4. Assists with the circulation of clinical/medical data/information via reports to departmental and Company employees as directed.
5. Prepares timely summary reports of the status of all responsible projects.
6. Assists with the interaction of database management staff (either in-house or vendor) to provide appropriate data output for the timely completion of required responsibilities.
7. Maintains technical proficiency and professional skills of self through literature review and attendance at conferences, seminars, courses, or clinics.
8. Follows departmental policies, procedures, and SOPs.
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:
1. A minimum of 2 years of experience in medical writing for clinical trials.
2. A working knowledge of Food and Drug Administration’s regulations, Good Clinical Practices guidelines and industry recommendations for the conduct of clinical investigations.
3. Ability to identify inconsistencies between case report form data and the output of the clinical database, or of current clinical trial status reports, or other administrative or clinical problems, and resolve them with minimal supervision.
4. Ability to deliver oral presentations and write regulatory documents, summary reports, and SOPs in a clear, focused, and concise manner.
5. Ability to achieve departmental and Company goals in a timely manner.
Contact erin.barraco@imclone.com
GENERAL SUMMARY:
Provides a leadership role within the Medical Information department by independently planning, developing, reviewing, and coordinating medical writing activities. Oversees the completion of assigned data presentations utilizing clinical/medical data/information. Interacts with other departments to provide the clinical/medical data/information necessary for the timely completion of their work.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
1. Writes, and edits, as necessary, clinical protocols/amendments, annual reports to regulatory authorities, clinical study reports, regulatory documents (eg, clinical sections of an IND, dossiers, or a BLA/NDA), ad hoc clinical reports, publications, and related documents.
2. Writes, and edits, as necessary, departmental Standard Operating Procedures (SOPs).
3. Assists with the integration of clinical trial data/information into concise and uniform reports for journal submission or non-routine submission to regulatory authorities.
4. Assists with the circulation of clinical/medical data/information via reports to departmental and Company employees as directed.
5. Prepares timely summary reports of the status of all responsible projects.
6. Assists with the interaction of database management staff (either in-house or vendor) to provide appropriate data output for the timely completion of required responsibilities.
7. Maintains technical proficiency and professional skills of self through literature review and attendance at conferences, seminars, courses, or clinics.
8. Follows departmental policies, procedures, and SOPs.
ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:
1. A minimum of 2 years of experience in medical writing for clinical trials.
2. A working knowledge of Food and Drug Administration’s regulations, Good Clinical Practices guidelines and industry recommendations for the conduct of clinical investigations.
3. Ability to identify inconsistencies between case report form data and the output of the clinical database, or of current clinical trial status reports, or other administrative or clinical problems, and resolve them with minimal supervision.
4. Ability to deliver oral presentations and write regulatory documents, summary reports, and SOPs in a clear, focused, and concise manner.
5. Ability to achieve departmental and Company goals in a timely manner.
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