Head writer functions

Head writer functions

In this post, you can ref key functions of Head writer in details. Based on this function list, you can set up daily duties, weekly duties, monthly tasks/activities.

I. List of Head writer duties:

1. Plan, prepare, write, review, edit, format, and finalize clinical and regulatory documents for ARIAD’s proprietary compounds.  Documents will include, but are not limited to, clinical protocols, clinical study reports, investigator brochures, annual updates to regulatory submissions, briefing books, and other regulatory submission documents.
2. Conduct peer review and assist with quality review of clinical, regulatory, and publication documents.
3. Collaborate with Clinical Research and Development colleagues, along with other ARIAD departments including, but not limited to, regulatory, safety, biostatistics, clinical operations, biology, medical affairs, and the commercial group.
4. Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams.
5. Lead and be involved with process development and process improvement initiatives both within the Medical Writing Department and throughout the organization.
6. To ensure compliance, remain informed on regulations and developments in medical writing, as well as maintain knowledge of product areas, current trends, and current literature.
7. If required, oversee other internal and/or external medical writers.
8. Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
9. Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization

II. List of Head writer qualifications

1. A minimum of BA or BS degree.  Advanced scientific degree in the life sciences preferred (MS or PhD).
2. 5 years or more of direct biotechnology or pharmaceutical industry experience as a medical writer.  Experience in oncology preferred.
3. Excellent ability to interpret and present scientific and clinical trial data and understand statistical analyses.
4. Excellent writing skills coupled with a comprehensive knowledge of the drug development process and regulatory guidelines, along with careful attention to detail.
5. Excellent interpersonal and communication skills, with the ability to work well both independently and as part of a team.
6. Initiative and the ability to handle a variety of projects simultaneously and productively with minimal supervision.
7. Proficient with computer software applications, in particular document management software.
8. Ensure compliance with all applicable laws, regulations and regulatory guidelines governing commercial and scientific interactions with healthcare professionals, payers, advocacy and other business partners.
9. Serve as a role model for compliant behavior that is consistent with the mission, vision and values of the ARIAD organization