Want Specialist, Clinical Trial Supply Management GCP Operations - Remote in Boston, MA - Cambridge, MA

Job title: Specialist, Clinical Trial Supply Management GCP Operations - Remote Company: BioNTech Job description: Become a member of the BioNTech Family! Based in Cambridge, MA and Gaithersburg, MD. We are committed to improving the health of people worldwide with our fundamental research and our work in the area of development of immunotherapies utilizing the full potential of the immune system to fight cancer, infectious diseases and other serious diseases. We believe in scientific rigor, innovation and passion as driving forces. BioNTech was founded by scientists and physicians to translate science into survival by combining fundamental research and operational excellence. With decades of deep immunology expertise and experience in developing and optimizing mRNA as part of its broad suite of novel technologies, the company is working with the global community to defeat life-threatening and serious diseases such as cancer, COVID-19, malaria and tuberculosis. The first ever approved mRNA vaccine was created in the labs of BioNTech in Mainz, Germany. A fully integrated immunotherapy powerhouse. We remain focused on bringing our broad pipeline of next-generation immunotherapies and vaccines to people around the world to address cancer, infectious diseases, as well as a growing list of other medical conditions. To accomplish this, we continue to be deeply rooted in science and academic research while also having built a fully integrated, global immunotherapy company with cGMP and GMP manufacturing facilities anchored around deep expertise in immunology and complemented by an expanding set of capabilities. Specialist, Clinical Trial Supply Management GCP Operations - Remote Responsibilities

• Provides template and supports preparing Pharmacy Manual
• Provides template and supports preparing Pharmacy Questionnaire
• Files and maintains an overview of CTSM documents that need to be filed in TMF
• Supports preparation and conduct of pharmacy trainings and Investigator meetings
• Provides input into monitoring manuals
• Supports managing complaints, deviations, changes, and other quality incidents for GCP topics derived at Clinical Pharmacies
• Supports writing and updating of SOPs

Qualifications Education

• University education in Pharmacy, Chemistry, Biotechnology, Biochemistry or related discipline or vocational training in Pharmacies or Hospital

Experience

• Relevant professional experience (usually

3 years) in Hospital / Pharmacy settings, Clinical Supply in Pharmaceutical or Biotech industry settings, or other relevant professional experience * Experience in supply chain and study drug logistics (set up and management) in global clinical trials up to Phase III

• Deep Knowledge of Pharmacy Manuals / Questionnaires
• Comprehensive Knowledge about GCP principles (e.g., Ethical Principles, Adequate Drug Information, etc.)
• Medical writing skills
• Standard office software proficiency (e.g., MS Office)
• Business-professional English language skills

Benefits for you: BioNTech US is committed to the well being of our team members and offers a variety of benefits supporting our diverse employee base. Salaried/Position-Targeted Hourly Employees working 30+ hours per week are eligible for our comprehensive benefits package. Benefits include but are not limited to: Medical, Dental and Vision Insurance Life, AD&D, STD and LTD Insurance HSA & FSA Spending Accounts Health & Wellness, including free onsite gym access Adoption & Surrogacy Assistance Vacation and Unlimited Sick Time Holidays and Floating Holidays, including discretionary winter shutdown 401(K) Plan with Significant Company Match Tuition Reimbursement and Professional Development Commuting Assistance and subsidized parking Discounted Home and Auto Insurance Pet Insurance Plus more benefits that will be shared upon hire! Have we kindled your pioneering spirit? Then apply now for our location Cambridge (Boston) and simply send us your application documents using our online form. *BioNTech does not differentiate on the basis of gender, political opinion, religion or belief, nationality, ethnic or social origin, age, sexual orientation, marital status, disability, physical appearance, health status or any other aspect of personal status. We are committed to creating a diverse and inclusive environment and are proud to be an equal opportunity employer. Most important - it's a match! BioNTech - As unique as you Expected salary: Location: Boston, MA - Cambridge, MA Apply Job!