Senior Medical Writer (Shanghai, China)

About Innovation Unit China

Innovation Unit China (China R&D Center) is a strategic innovation hub within Boehringer Ingelheim’s global R&D network, established to harness China’s rapidly evolving scientific capabilities and vibrant innovation ecosystem. By integrating Experimental Medicine, External Innovation, Development CMC, and Clinical Pharmacology & Non-clinical Safety Science, IU China connects promising science with early development expertise to accelerate high-potential opportunities, contribute to the global pipeline, and help accelerate breakthrough therapies for patients in China and around the world.

Responsibilities

- Conceive new approaches and devise strategies for clinical document preparation and overarching company-wide processes with strategic impact on clinical development programs, clinical trial conduct and reporting; and lead their implementation. Promote ideas and align with leadership. Keep appraised of external best practices and identify ways to apply to and improve internal standards. Communicate new regulatory guidance to the CO MW group and other functions, and implement relevant changes. Scrutinize document timelines and promote creative solutions to the optimization of the development of key clinical documents.

- Lead or contribute to BI-internal or external (e.g. TransCelerate) international cross-functional working groups, and global SOP development. Represent the MW function in cross-functional working groups; interact with leadership, influence related strategic objectives, and ensure their implementation.

- Assume the role of an expert, including thorough knowledge and understanding of the document and analysis standards.

- Mentor and train other medical writers to foster their writing competencies. Provide consultancy and expert advice in case of issues related to document processes and strategy. Develop colleagues in regard to MW standards and their therapeutic area knowledge. Give expert advice to other functions.

- Responsible for the preparation of clinical documents on project-level, globally and for China. Document types comprise clinical documents required for early clinical development of BI compounds. This includes writing, planning, coordinating, developing of document strategies, resolving and integrating review comments, and overseeing of timelines. Contribute to scientific and regulatory discussions within the trial and project teams. Demonstrate expertise in at least one of Boehringer’s therapeutic areas.

- Implement MW standards in the governance of external providers. Ensure quality of clinical documents assigned to external providers by appropriate oversight, training, and cost control.

Qualifications

- Doctoral degree in Pharmacy, Medicine or Life Science. EMWA/AMWA advanced certificate desirable. Minimum of 4 years of experience in regulatory medical writing (as a Medical Writer/ Senior Medical Writer or in an equivalent role) and demonstrated ability to successfully lead international project teams or working groups; knowledge in Boehringer’s therapeutic areas.

- Demonstrated experience in developing clinical and regulatory documents in English and Chinese, with a sound understanding of Chinese regulatory requirements and document expectations.

- Project management skills, including time and resource management, ability to manage projects effectively across regions and in matrix environments, ability to handle numerous complex tasks simultaneously and manage variable workload, strong interpersonal and social skills, ability to communicate effectively in large international cross-functional teams, ability to oversee complex projects with third party providers, ability to manage conflicting objectives, and presentation skills; diplomacy; cultural sensitivity; ability to conceive and implement process improvements; proficiency in word processing and presentation software; excellent written and verbal English skills.

- Ability to independently and effectively communicate complex clinical information in writing for the target audiences; scientific and analytical thinking; understanding of medical concepts, statistics, pharmacokinetics, and pharmacodynamics; ability to comprehend and interpret clinical data; understanding of the clinical development process and relevant global and local regulatory guidelines; knowledge of requirements for regional and local marketing approvals.

- Experience: Worked across key clinical documents for submission to health authorities globally and in China; evidence of strong teamwork at international project level and experience with mentoring staff; knowledge in at least one of Boehringer’s therapeutic areas.