job description
Join Clinchoice, Inc., a global leader in clinical research and medical affairs, as a Senior Associate, Medical Affairs based in Bali, Indonesia. In this pivotal role, you will drive process improvements, ensure compliance, and deliver high-quality medical and regulatory documentation to support our clients in the pharmaceutical and biotechnology sectors.
As a key member of our Medical Affairs team, you will collaborate with cross-functional teams to enhance operational efficiency, uphold scientific integrity, and meet stringent regulatory standards. This is an exceptional opportunity to leverage your expertise in medical writing, regulatory support, and scientific review while working in a dynamic, remote-first environment.
Clinchoice is committed to fostering innovation, professional growth, and work-life balance. If you are a detail-oriented professional with a passion for healthcare and a drive to make an impact, we invite you to apply and become part of our mission to advance global health.
Responsibility
- Lead and optimize medical writing processes, including the development of clinical study reports, regulatory submissions, and scientific publications.
- Provide expert regulatory support to ensure compliance with global standards (e.g., ICH, FDA, EMA) and timely submission of documentation.
- Conduct thorough scientific reviews of medical and clinical data to ensure accuracy, consistency, and alignment with regulatory requirements.
- Collaborate with cross-functional teams, including clinical operations, regulatory affairs, and quality assurance, to streamline workflows and improve efficiency.
- Develop and maintain labeling documentation, including core data sheets, patient information leaflets, and packaging inserts.
- Identify opportunities for process improvement and implement best practices to enhance quality, compliance, and delivery timelines.
- Mentor junior team members and provide guidance on medical writing standards, regulatory guidelines, and scientific best practices.
- Stay updated on industry trends, emerging regulations, and advancements in medical affairs to ensure continuous improvement.
Qualifications
- Bachelor’s degree in Life Sciences, Pharmacy, Medicine, or a related field; advanced degree (e.g., Master’s, PhD, PharmD) is a plus.
- Minimum of 5 years of experience in medical affairs, medical writing, or regulatory affairs within the pharmaceutical, biotechnology, or clinical research industry.
- Proven expertise in medical writing, including clinical study reports, regulatory submissions, and scientific publications.
- Strong understanding of global regulatory requirements (e.g., ICH, FDA, EMA) and their application in medical documentation.
- Excellent attention to detail, analytical skills, and ability to interpret complex scientific data.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) and experience with document management systems.
- Exceptional communication skills, both written and verbal, with the ability to convey scientific information clearly and concisely.
- Ability to work independently in a remote setting while collaborating effectively with global teams.