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.  Offers

guidance and support to junior staff as necessary.  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, reviews, 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.

    Writes, reviews, and edits, as necessary, departmental Standard Operating Procedures (SOPs).

2. Assists with the integration of clinical trial data/information into concise and uniform reports for journal submission or non-routine

   submission to regulatory authorities.

3. Assists with the circulation of clinical/medical data/information via reports to departmental and Company employees as directed.

4. Prepares timely summary reports of the status of all responsible rojects.

5. 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.

6. Maintains technical proficiency and professional skills of self through literature review and attendance at conferences, seminars, courses, or clinics.

7. Follows departmental policies, procedures, and SOPs.

ESSENTIAL KNOWLEDGE, SKILLS, EXPERIENCE:

1.Two years of progressively increasing experience, either in clinical affairs, medical writing, or regulatory affairs, within the

   pharmaceutical industry.

2. A working knowledge of Food and Drug Administrations 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.

6. An advanced degree in a discipline relevant to the pharmaceutical industry, such as Nursing, Life Sciences, Pharmacy or Medicine.