Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At Bayer you have the opportunity to be part of a culture where we value the passion of our employees to innovate and give them the power to change.
Manager, Medcial Affairs
YOUR TASKS AND RESPONSIBILITIES
- In clinical trials:
- Supports country selection, feasibility assessments, investigator identification and initial medical discussions with investigators
- Supports development of study specific documents such as protocol writing of specific sections including inclusion/exclusion criteria, amendments, review and approval of the PI/IC, and review of CRF and Statistical Analysis Plan
- Develops standard training material, is involved in training Study Team members and site staff on medical aspects of the study, and provides support for medical topics and questions
- Writes medical review plan, performs ongoing medical review of clinical data, Attends blinded review meeting, approves final patient validity, and provides final sign-off on unresolved data queries
- Reviews statistical tables, identifies additional analyses, interprets clinical data, prepares narratives for CSR and reviews final study CSR, writes Chinese Clinical Research Report
- Contributes to regulatory INA and NDA submissions and clinical publications
- Prepare the medical section of briefing documents for discussions/meetings with regulatory authorities • Develop responses to study-specific medical issues that may be raised by regulatory agencies
- In marketing support:
- Co-operate with marketing function to commercialize new products to the market.
- Review and provide medical information for marketing materials.
- Develop and organize local NIS, is responsible for the proper processing of local/global NIS according to global standards or local procedure.
- Responsible for ISS submission, as a contact person with investigators to carry out ISS and work closely with external patterns to ensure ISS be in good quality.
- Oversees, executes and coordinates internal participants for medical events, provides content support to Marketing at conferences and meetings, and participates in important congresses
- Provides scientific analysis of relevant competitive data and offers helpful positioning in the management of problem situations
WHO YOU ARE
- Master or above degree in clinical medicine
- Proficiency in BasicMicrosoft Word, PowerPoint and Excel
- Fluency in English
- Excellent communication skill
- At least 2 years clinical experience
- At least 5 years international pharmaceutical industry experience
- Management at least 2 years
- Knowledge in :
- Assigned therapeutic areas, clinical experience is preferred
- Chinese/ICH GCP guidelines and SOPs
- Drug development process
- Clinical trial methodology
- China regulatory environment
- Pharmaceutical industry compliance rules
- Personal characteristics
- Open and proactive
- Team work
Are you looking for a new challenge where you can show your passion for innovation? Are you interested in working as part of a global team to improve people’s lives? Then send us your online application including cover letter, CV and references.
Bayer welcomes applications from all individuals, regardless of race, national origin, gender, age, physical characteristics, social origin, disability, union membership, religion, family status, pregnancy, sexual orientation, gender identity, gender expression or any unlawful criterion under applicable law. We are committed to treating all applicants fairly and avoiding discrimination.
Reference Code: 148761
Functional Area: 医学事务&药物警戒