Meet the Team
Director, Medical Writing | Regulatory Affairs, Health Services Administration
Rufus Robertson, MSc.
As a Medical Writer in the Pharmaceutical and Biotechnology Life Sciences Industry, I have a proven and distinguished track record of quality delivery of clinical development documentation which includes Clinical Study Reports, (Phase I-IV), Clinical Protocols, Data Safety Update Reports (DSURs), Investigator Brochures, INDs, IMPDs, NDAs, BLAs and Patient Narratives that adhere to ICH/GCP Guidelines, Global Regulations, SOPs, Quality and Compliance.
I am committed to quality and have played a key role in developing and implementing best practices in medical writing. I excel at fostering collaboration among cross-functional teams, contributing to a culture where clear communication is integral to the clinical development process. My objective is to drive innovation in medical writing, ensuring that complex scientific data is accessible and regulatory compliant, which is crucial for advancing healthcare services.
I hold a Master's Degree in Health Services Administration and hold membership with RAPs, being certified in Regulatory Affairs.
Sheilah Johnson-Rocha MSc., MAPM
Founder
With a career spanning 21 years in the life sciences industry, I have excelled in dynamic environments, particularly as Therapeutic Area Leadership for Oncology and Cell Therapy. My dual role in operational and program/portfolio leadership has equipped me with the expertise to develop intricate development plans, lead cross-functional teams, and proactively navigate the evolving trial lifecycle.
As the Director of Oncology and Cell Therapy Therapeutic Area Leadership, I successfully established and led a new independent business unit while managing 13 direct reports and over 100 indirectly. This encompassed overseeing all facets of clinical operations, including budgeting, resource allocation, quality control, risk assessment, and vendor management.
My passion for driving innovation in life sciences is reflected in my keen interest in emerging therapies, personalized medicine, and the integration of cutting-edge technologies into clinical trial design. Staying abreast of industry advancements, I continuously leverage innovations to deliver breakthrough treatments to patients.
I hold a Master's in Science and Certificates and Licensures include:
Project Management, PMP: Certificate no. 5064855
Expert Public Health and Epidemiology
Todd Hall, MPH
A dedicated public health specialist with extensive experience in data analysis, project management, and vaccine distribution. My journey in public health began with a Bachelor of Science in Public Health Epidemiology from the University of North Texas and has led me through impactful roles at the CDC, where I honed my skills in managing complex projects and leveraging data for strategic decision-making.
As a Public Health Specialist, I spearheaded health data analysis and vaccine distribution for a population of 65 million, ensuring equitable access and strategic decision-making. My experience as a Public Health Analyst involved managing concurrent projects, extracting and analyzing critical data from long-term care facilities, and coordinating the distribution of 18 million vaccines. During the COVID-19 pandemic, I served as a COVID-19 Public Health Advisor, orchestrating projects, enforcing health screening protocols, and ensuring efficient vaccine distribution.
I hold certifications in Leadership and Management Styles, AI and Machine Learning in Business, Infection Prevention & Control, and Infection Disease Outbreak. Additionally, I have completed Project Management Skills for Leaders and received honors from the Society for Collegiate Leadership & Achievement (SCLA). I am also certified in CPR AED BLS.
My mission is to improve public health outcomes through data-driven insights, strategic project management, and innovative solutions.
Schedule Your Consultation Today
Take the next step towards advancing your clinical programs. Book your consultation now to discuss how we can support your specific needs and objectives.
Why Choose Our Consultant?
-
Industry Expertise: Extensive experience in biotechnology and pharmaceutical clinical operations and program management.
-
Strategic Innovation: Proven track record of developing and implementing successful strategies and solutions.
-
Cutting-Edge Solutions: Expertise in AI and digital tools tailored for the life sciences sector.
-
Commitment to Quality: Dedication to maintaining the highest standards in operational and quality management.