Annette Meyer Ruff Email & Phone Number

Castro Verde, Pt

New York, New York, Us

Independently plan and prepare clinical documents by organizing, analyzing, and interpreting scientific and statistical data.Drive the document preparation process for an assigned clinical program or programs.Reach consensus with the study team on time frames for deliverables and overall document messages.Ensure submission-ready clinical documents are prepared according to ICH guidelines, other relevant regulatory guidelines, and Pfizer standard processes and guidelines.Participate in study team and program-level meetings.Work closely with the study/program team to ensure that results and messages in clinical documents accurately reflects the data in the final tables, figures, and listings, and other information sources.

Watford, Hertfordshire, Gb

Manage all writing for Global Medical OperationsDraft, review and prepare protocols and reports for clinical trials regarding the safety and efficacy of drugs and devices (Phase 1 to 4)Lead clinical affairs team in all medical writing activities across multiple therapeutic areasDevelop, maintain and update templates for clinical documents including protocols, clinical study reports, investigational drug brochures, Integrated Summaries of Efficacy and Safety, literature reviews and associated documents including regulatory dossier to standardize the development process

Watford, Hertfordshire, Gb

• Manage Process Improvement laboratory developing animal-origin free culture methods for cellular therapy product in late-stage clinical trials; supervise four associate scientists• Support production of HP802-247: design material, method, and instrument validations; write protocols and reports; assist with OOS investigations• Collaborate with scientists at manufacturing site in Lausanne, Switzerland• Develop new methods for in-process testing of cells in culture• Lead Technology Transfer of methods from Research and Development to Quality Control and Manufacturing

Gaithersburg, Maryland, Us

• Lead method development, pre-validation and validation of analytical assays • Represent department in project meetings and collaborations as needed• Contribute to the scientific and technical development for the group• Prepare and review presentations, protocols and reports and standard operating procedures• Ensure compliance with cGMP and Good Documentation Practices

Cambridge, Massachusetts, Us

• Lead scientist responsible for developing protocols, analyzing data and writing reports for qualification and validation of Manufacturing Processes and Quality Control Methods to FDA/ICH guidelines for Phase III Clinical Trial of human autologous stem cell product• Facilitate transfer of methods from Development to Quality Control; validate methods in QC• Lead CAPA and OOS investigations

Livonia, Mi, Us

Teach microbiology and introductory biology (lecture and lab) to science and health science students.

New York, New York, Us

Used traditional screening methods to identify novel antibacterials. • Developed methods and adapted in vitro antibacterial assays to 96 and 384 well formats amenable to robotic screening; validated screens for high throughput screening.• Supervised and managed execution of multiple full-file screens of company compound collection (2-3 million compounds) against a variety of bacterial species.• Developed proficiency in bacterial genetics and managed mechanism of action studies on both Gram negative and Gram positive organisms.• Applied molecular biology techniques in mechanism elucidation: cloning, PCR, oligonucleotide mutagenesis, sequencing and sequence analysis.

Antiviral drug discovery research. Human herpesvirus antivrial drug discovery.• Independently cloned and expressed highly active herpesvirus maturational proteases.• Developed expression system to monitor activity of viral proteases in bacterial cells.• Characterized enzymatic activity, developed in vitro screen and supervised screening of compound library for enzyme inhibitors.• Lead studies to determine antiviral mechanism of action of inhibitors of HSV-1 and CMV.

New York, New York, Us

Animal virus vaccine research/diagnostic assay development. Antiviral drug discovery.

Ab, Biological Sciences

Ms, Biology