In-house opportunity
SUMMARY OF POSITION:
This individual has full responsibility for facilitating and managing assigned medical writing personnel and the preparation of clinical documents such as protocol synopses and protocols, clinical study reports (CSR), integrated summary documents, clinical portions of INDAs NDAs, ANDAs, as well as SOPs. The principal will develop processes and templates for clinical documents. The principal will also be responsible for the line management of a Senior Medical Writer and an Associate Medical Writer.
ESSENTIAL FUNCTIONS:
1. Will plan, write, edit, and review 100% of clinical documents including, but not exclusive to, protocol synopses, clinical protocols, clinical study reports (CSRs), integrated summary documents, clinical portions of INDAs, NDAs, ANDAs, and the creation of SOPs.
2. Will be responsible for developing processes and templates for all clinical documents.
3. Will be responsible for the line management of a Senior Medical Writer and Associate Medical Writer. These duties will include hiring, performance planning, and evaluation.
4. The principal will review all documents created and edited by the Senior Medical Writer and Associate Medical Writer.
5. The principal will collaborate with other project team members to gather information, establish timelines and priorities, delineate individual roles in the preparation of specific documents, and ensure the quality of all clinical documents.
6. The principal will maintain the consistency of style, format, and content for clinical documents to ensure adherence to FDA, CTD (ICH), and other regulatory guidelines.
7. The principal will be responsible for appropriate planning and resource allocation for all writing projects.
8. The principal will provide input, when appropriate, for clinical publications.
9. The principal will assist with the integration of clinical trial data and information into concise and uniform reports for poster assembly, slide presentation, journal submission, or non-routine submission to regulatory authorities, using source documents from various sources and assuring a consistent style and approved format.
10. The principal will assist with the circulation of clinical/medical data/information via reports to departmental and Company employees, as directed.
11. The principal will assist with the interaction of data management, biostatistics, and pharmacokinetics management staff (either in-house or vendor) to provide appropriate data output for the timely completion of required responsibilities.
DEPARTMENT SPECIFIC/NONESSENTIAL FUNCTIONS:
1. Will be responsible for insuring the completion and documentation of all clinical writing projects.
2. Will educate self and medical writing group regarding current products, customer needs, and clinical applications.
3. Other duties, as assigned, with or without accommodation.
EXPERIENCE:
Minimum of 4 years experience in the writing of medical or technical documents, including working in a multifunctional team environment. Minimum of 2-3 years managerial experience.
1. Demonstrated leadership and collaboration abilities.
2. Ability to effectively handle conflict through proactive action and direct and timely communication.
3. Demonstrated attention to detail and experience to check behind the scenes to ensure documents contain the appropriate content.
4. Knowledge of FDA pharmaceutical guidelines and Common Technical Document (CTD) format.
5. Strong organizational and planning skills.
6. Excellent interpersonal skills with demonstrated ability to work in a team environment and effectively interact with people at many levels of the organization.
7. Ability to identify inconsistencies between data listings and the output of biostatistics, or of current clinical trial status reports, or other administrative or clinical problems, and to resolve them with minimal supervision.
8. Strong managerial abilities.
CONTACT:
