Medical Advisor - Clinical Development (Remote)
About the Role
We are seeking a Medical Advisor - Clinical Development (Remote) to contribute to the execution of Clinical Development & Medical Affairs (CDMA) activities in Japan. This role is crucial for aligning clinical development with the therapeutic area strategy, particularly during the transition from clinical development to commercialization.
What You'll Do
- Strengthen the value of our products by providing robust medical and scientific guidance in collaboration with global teams.
- Ensure and support Japanese submissions and registrations for respective products, working closely with regulatory and clinical development teams.
- Support strategic decision-making based on comprehensive project and trial data within the therapeutic area.
- Prepare Integrated Customer Plans (ICP) to address specific needs in Japan, collaborating with Marketing and Market Access teams.
- Build new scientific evidence through collaboration with external experts via clinical and pre-clinical research and Real World Evidence (RWE) studies.
- Contribute to benefit/risk evaluations of products and gain insights from external experts to propose medical strategies.
- Participate in strategy and activity review meetings, ensuring compliance with ethics and regulations.
- Define necessary trials to address key questions regarding our products and their development projects.
Requirements
- Master's degree in life sciences; MD or PhD preferred.
- Experience in therapeutic areas, particularly nephrology or rare diseases, in clinical or research settings.
- Experience in product launches is preferred.
- Strong project management and cross-functional collaboration skills, with the ability to work in global matrix teams.
- Excellent negotiation and communication skills for both internal and external stakeholders.
- English proficiency (TOEIC score >800).
- Knowledge of regulations related to clinical research, clinical trials, and clinical development.
Nice to Have
- Experience leading team projects related to evidence generation, medical strategy, and new drug launches.
- People management experience is valued but not mandatory.
What We Offer
- Competitive salary range of $120,000 - $150,000 per year.
- Comprehensive benefits package including health insurance and retirement plans.
- Flexible remote work options to promote work-life balance.
- Opportunities for professional development and career growth.
- Collaborative work environment with a focus on innovation and scientific advancement.
This Medical Advisor role offers a unique opportunity to work remotely while contributing to impactful clinical development strategies in a leading pharmaceutical company.
Who Will Succeed Here
In-depth knowledge of Clinical Development processes and regulatory compliance, particularly in the pharmaceutical industry, with hands-on experience using tools like Veeva Vault for document management.
Strong project management skills with proficiency in Agile methodologies to effectively lead cross-functional teams remotely, ensuring timely delivery of clinical projects.
Proven track record in negotiation and collaboration with stakeholders across various departments and external partners, demonstrating an ability to align clinical strategies with business objectives.
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