Medical Research Specialist

Job description

As Medical Research Specialist, you will be responsible for strategy setting of Biogen China study execution and publication. You will collaborate deeply with medical manager to ensure the data generation of Biogen China medical initiated or investigator-initiated studies including but not limited to developing/updating applicable local affiliate SOPs, protocol creation, leading feasibility assessments, and general conduct of Phase IV studies, IITs, and other studies to address unmet needs of our stakeholders. Study development and operation Manage and provide accountability for operations of the projects, as defined by the study protocol, contracts, GCP, SOPs and other applicable laws. Maintain or establish China study SOPs, handbook, guidance of clinical operation which are aligned with Biogen global SOPs. Collaborate with TA medical to develop study protocols for Biogen China sponsored studies. Serve as primary contact point of China data generation team for internal/external communications and build strong collaboration model with global/ regional functions. Collaborate with other functional groups within Biogen where necessary to support milestone achievement and to manage study issues and obstacles Responsible for governance process of data generation in terms of study submissions, maintain study tracking system (MARS) according to global and local SOPs Select, manage vendors and ensure study quality, provide all relevant trainings, SOPs, materials to vendor Owns and coordinates study vendor contracts/ payments for all post-marketing research activities Oversight Study quality Achieve project quality by identifying quality risks and issues, responding to issue raised by study team members and planning, implementing appropriate corrective and preventative action plans Collaborate with TA medical team to manage site quality, including direct supervision of project Clinical Research Associates (CRA) and monitoring deliverables Lead and collaborate with TA medical team for study audit preparation Data Analysis and Publication Set clear publication objective, strategy and timeline which aligned with TA medical and Publication Lead Coordinates with Global Medical resources in order to ensure speed and accuracy of data analysis for local studies; coordinate with global publication teams with local TA for publication related process/project managements Ensure local vendors complete data analysis timely and accurately, timeline will be confirmed with medical cross-functional team Select qualified publication vendor and ensure vendor be trained to meet Biogen requirements and standards Ensure appropriate local publication SOPs align with all global SOPs as applicable Qualificiations: Bachelor’s degree in Life Sciences, Medicine, Pharmacy, or a related scientific discipline preferred. Minimum 2 years of experience in clinical research, clinical studies, and/or scientific publications; relevant clinical experience is required. Proven project management experience with the ability to manage multiple priorities and stakeholders. Excellent written and verbal communication skills in both English and Chinese Good team player, fits in the environment with international, diverse, teamwork culture Strong customer orientation in science based Job Level: Professional Why Biogen? We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen. All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.