Senior Manager-Associate Director, Medical Writing

Clinical Development           ·          Beijing, China        ·           Full time 

Job Description

Title: Senior Manager-Associate Director, Medical Writing

Reports to: VP, Clinical Operations & Sciences

Summary:

This role leads Medical Writing and Translation activities, both internal and external, including researching, writing, translating and editing of clinical study reports, protocols, Investigator’s Brochures, and IND/CTA, NDA/BLA or other regulatory submission.

Duties And Responsibilities:

• Lead and direct medical writing and translation activities from IND/CTA to NDA/BLA for the clinical trials/programs, as well as publication activities for the purpose of new product launch; ensure appropriate resources are in place to support all medical writing and translation needs to deliver documents for regulatory submissions and publications within established timelines and budget.
• Contribute to overall project management and to cross-functional working groups (regulatory affairs, clinical operations, clinical development, data management, and statistics) as needed to facilitate efficient development and finalization of clinical, non-clinical and regulatory documents for submissions.
• Ensure that medical writing and translation activities are coordinated with other functions, including Clinical Operations, Pharmacovigilance, Regulatory and other groups.
• Establish and maintain the operational standards for the medical writing and translation activities (e.g. style guidelines, templates, QC and etc.).
• Manage the completion of documents and other assigned tasks within established timelines and with high quality in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes.
• Manage the work of CRO for medical writing and translation.
• Evaluate supplier capability and identify qualified supply sources based on procurement policy and process.
• Be responsible for the relationships with suppliers to ensure information protection, drive performance management, deliver continuous quality and cost improvement.
• Process the medical writing and translation requests to CROs and/or other relevant suppliers: preparing, dispatching, managing, and communicating the requests, and coordination with external suppliers worldwide.
• Conduct the review of supplier performance and address issues of non-conformance or low performance.
• Ensure negotiations are being conducted to the best value and total cost of ownership and according to confidentiality and compliance requirements.
• Participate in recruiting and mentoring of staff, and budget planning.
• Perform other related duties as assigned by management.

Qualifications:

• Master in Life Science or equivalent
• At least 3 years in medical writing and 3 years in translation, including participating in IND/CTA and/or NDA/BLA submissions to the China NMPA (SFDA), US FDA, or EMA (MAA)
• Experiences in preparing documents in English and Chinese, including protocols, study reports, investigator brochures, safety updates, and clinical sections in regulatory dossiers, as well as publications
• Attention to detail with an ability to perform critical review of various types of documents
• Demonstrated ability to communicate and write clearly, concisely, and effectively, with an aptitude for compilation, analysis, and presentation of data
• Strong understanding of process implications as related to strategic sourcing, cost reduction, and quality management
• Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high quality documents according to demanding timelines
• Knowledge of drug development, clinical research, study design, biostatistics, regulatory environment, and medical terminology
• Ability to think strategically to drive the project and departmental development further
• Demonstrated ability to work as a team player with multi-disciplinary project teams
• Independently motivated, good problem-solving ability, and work cross-culturally
• Excellent oral and written communication skills in Chinese and English

Competencies:

• Problem Solving–Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations; Reasons when dealing with emotional issues.
• Interpersonal Skills–Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things.
• Communication–Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Responds well to questions; Demonstrates group presentation skills; Writes clearly and informatively; Edits work for spelling and grammar; Varies writing style to meet needs.
• Leadership–Exhibits confidence in self and others; Inspires and motivates others to perform well; Effectively influences actions and opinions of others; Accepts feedback from others; Gives appropriate recognition to others.
• Ethics–Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
• Strategic Thinking–Develops strategies to achieve organizational goals; Understands organization’s strengths & weaknesses; Analyzes market and competition; Identifies external threats and opportunities; Adapts strategy to changing conditions.
• Judgment–Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
• Initiative–Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Takes independent actions and calculated risks; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
• Innovation–Displays original thinking and creativity; Meets challenges with resourcefulness; Generates suggestions for improving work; Develops innovative approaches and ideas; Presents ideas and information in a manner that gets others’ attention.

Please apply by sending your resume (.pdf format) to jobs@briibio.com.

The above is intended to describe the general content of and requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities or physical requirements. Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Brii Biosciences is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. We value diversity and are committed to creating an inclusive environment for team members from all backgrounds.

Please click here to apply.