Responsible for appropriate reviewing of all safety data from various sources (e.g. pre-clinical, clinical trial data, post-marketing, literature) throughout the development process as well as post marketing for assigned products and development compounds.
Provide strategic leadership for programs that integrate the individuals extensive knowledge in the disease area, knowledge from the medical community around the world and the commercial, research, regulatory, and medical research goals in the disease area.
The Med Dir is responsible for external-facing interactions with medical experts and other stakeholders, and is expected to build and maintain strong opinion leader relationships. The GMAL engages in external collaborations in order to gain insight and to facilitate clinical development and life cycle plans.
Maintains navigational electronic database to document on- and off-label unsolicited requests for information from HCPs in accordance with Haemonetics internal guidelines and FDA guidance for industry.
Manage the writing and completion of documents and other assigned tasks within established timelines (editing and QC) and with highest quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
The Medical Director is the lead clinical authority and supervisor within the management team and for all clinical services provided throughout the unit; director is responsible for the development and implementation of compassionate, cost-effective medical and psychiatric care within the unit.
In this role, the selected candidate will design and implement protocols for Phase I and II clinical trials including trial rationale, design methodology, number of subjects to be recruited, biomarkers used, informed consent and confidentiality, etc.
In this role, you will Provide medical insight to the development of design specifications; medical expertise to regulatory submissions; participation in meetings with regulators (e.g. FDA); review of marketing and promotional materials.