Regulatory Affairs Japan Jobs in Decatur, GA (NOW HIRING)

About PharmaEssentia:
It's not often you get the chance to make a real impact on the lives of others, while expanding your own possibilities. You'll find that rare opportunity at PharmaEssentia. Join us, and let's transform lives, together.
PharmaEssentia Corporation is a rapidly growing biopharmaceutical innovator. We are leveraging deep expertise and proven scientific principles to deliver effective new biologics for challenging diseases in the areas of hematology and oncology, with one product approved and a diversifying pipeline. We believe in the potential to improve both health and quality of life for patients with limited options today through the combination of rigorous research and innovative thinking. Founded in 2003 by a team of Taiwanese-American executives and renowned scientists from U.S. biotechnology and pharmaceutical companies, today we are listed on the Taiwan Stock Exchange (TWSE: 6446) and are expanding our global presence with operations in the U.S., Japan, Singapore, South Korea, and China, along with a world-class biologics production facility in Taichung.
Position Overview:
The primary responsibility of a Medical Science Liaison (MSL) is the exchange of medical information with health care professionals (HCPs) involved with the management of myeloproliferative neoplasms (MPNs). As a key member of the Medical Affairs Team, you will facilitate and develop the relationship with the medical/scientific community including physicians and medical centers, by communicating product-related information to investigators and institutions. In addition, you will provide information on research developments, new clinical trials and new concepts in medical treatment, to bring our flagship product to market for the treatment of polycythemia vera (PV).
The hired candidate must reside in the designated territory (GA, AL, MS, LA, and TN). This is a remote role.
Key Responsibilities:

• Establish a respectable PharmaEssentia presence in the medical community.
• Identify and develop relationships with the medical community, thought leaders, and treatment advocates.
• Liaise and support the development of key and regional opinion leaders within a broad customer segmentation (community clinics, integrated delivery networks (IDNs), academic centers, etc.).
• Provide high quality medical and scientific support/communications to internal and external customers (e.g., advisory board meetings, regional training courses/workshops together with KOL/ROL, support of speakers with presentations and literature research)
• Lead medical education (disease statement, guidelines, and product information upon FDA approval).
• Manage studies and ensure that proposals are aligned with medical objectives within PharmaEssentia locally and globally. Ensure study projects are in line with commercial objectives.
• Maintain a high level of scientific and technical expertise in hematology, oncology, and blood disorders. Develop and increase knowledge of medical literature. Prepare and present critical reviews of scientific publications and congresses, internally and externally.
• Complete necessary documentation in order to ensure knowledge preservation (e.g., CRM reports). Utilize the necessary tools to develop and follow up on strategic measures (project plans).
• Write and ensure timely submission of locally relevant abstracts at congresses.
• Provide cross-functional support for Market Access and other Medical Affairs activities.
• Monitor competitor activities and marketplace changes.

Qualifications and Experience:

• Advanced Degree Required (PhD, PharmD, or MD)
• Experience in the pharmaceutical industry, including 3+ years in a field medical/MSL role
• Broad knowledge of general medicine with a focus in hematology, oncology or interferons.
• Knowledge in planning and execution of scientific studies and clinical trials
• Ability to develop and maintain relationships with key thought-leaders.
• Ability to introduce the disease state to the KOL community and articulate complex programs.
• Development of product knowledge and knowledge of Company and science
• Excellent writing and oral communication skills (including presentations)
• Strong networking skills (includes internal teams)
• On-time completion of goals with high-quality results
• Project planning and execution
• Quality of judgment and decision making
• Initiative on addressing issues for the team ("roll up your sleeves attitude")
• Ability to maintain collaborative relationships within a dynamic team environment.
• Adherence and compliance with all required regulatory and GCP guidelines.

The expected base salary range for this position is $165,240-238,680. Salary offers are based on a wide range of factors including relevant skills, training, experience, education and geographical location. Market and organizational factors are also considered. In addition to base salary and a competitive benefits package, successful candidates are eligible for short-term and long-term incentives.
Benefits of working with our team:
PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:

• Comprehensive medical coverage
• Dental and vision coverage
• Generous paid time-off
• 401(k) retirement plan with competitive company match
• Medical & Dependent Care Flexible Spending Account
• Monthly cell phone reimbursement
• Employee Assistance Program

Benefits of working with our team:
PharmaEssentia USA strives every day to improve the lives of patients as well as our employees. As a valued member of PharmaEssentia USA, you will enjoy the following benefits:

• Comprehensive medical coverage
• Dental and vision coverage
• Generous paid time-off
• 401(k) retirement plan with competitive company match
• Medical & Dependent Care Flexible Spending Account
• Up to $150 monthly cell phone reimbursement
• Employee Assistance Program
• Free parking

EEO Statement:
At PharmaEssentia USA, we are committed to providing an environment of mutual respect where equal employment opportunities are available to all applicants without regard to race, color, religion, sex, pregnancy (including childbirth and related medical conditions), national origin, age, physical and mental disability, marital status, sexual orientation, gender identity, gender expression, genetic information (including characteristics and testing), military and veteran status, and any other characteristic protected by applicable law. PharmaEssentia USA believes that diversity and inclusion among our team are critical to our success as a global company, and we seek to recruit, develop and retain the most talented people from a diverse candidate pool.
PharmaEssentia does not accept unsolicited agency resumes. Staffing agencies should not send resumes to our HR team or to any PharmaEssentia employees. PharmaEssentia is not responsible for any fees related to unsolicited resumes from staffing agencies.
At PharmaEssentia, our goal is to treat as many people with cancer as possible. That means challenging the status quo with better science that leads to better lives. By joining our team, you will not only expand your own possibilities, but you will contribute to expanding options for people with cancer.
https://us.pharmaessentia.com/careers/