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POSITION SUMMARY:
? Learns the medical writing role and pharmaceutical industry and business.
? Learns to work in a team environment and matrix.
? Learns internal standards, regulatory, and publishing guidelines.
? Learns internal systems, tools, and processes.
? Helps to prepare sections of documents and prepares basic documents (therapeutic area-specific) (see examples under "principal responsibilities") under close supervision (is closely trained/coached by a senior-level writer or manager).
? Assists with routine tasks per established procedures (see examples under "principal responsibilities")
PRINCIPAL RESPONSIBILITIES:
1. List major responsibilities and duties of the position. List most complex or difficult parts of job first and indicate percentage of time required to perform each task. Describe those quantitative aspects of the position which reflect measures that are applicable to the position’s major responsibilities or end results.
2. Helps prepare sections of documents or write basic documents under close supervision such as table of studies, narratives, simple protocol amendments, simple IB updates, IB addenda.
3. May assist with document QC, abbreviations, references, literature searches, table creation, and other basic tasks.
4. Attention to accuracy, format, and consistency.
RESPONSIBILITY FOR OTHERS (If applicable): Not Applicable.
5. Learns and adheres to SOPs, templates, best practices, policies, Medical Writing Style Guide.
6. Regularly meets with manager and mentors, and attends departmental meetings.
7. Attends cross-functional meetings with other writers as appropriate (eg, project kick-off and review meetings).
8. Completes all time reporting, training, and metrics database updates as required.
Education
A university/college degree is required. An advanced degree (eg, Masters, PhD, MD) is preferred. Relevant pharmaceutical experience is a plus.