Cindy Willis Email and Phone Number
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Medical writing professional with experience preparing clinical and nonclinical documents from IND through summary documents in the BLA that includes driving document strategy and key messages. Lead medical writer preparing investigator brochures, clinical protocols and protocol amendments (phases 1-3 and observational), informed consent forms, clinical study reports, safety narratives, development safety update reports, clinical and nonclinical CTD module 2 summaries, R&D research reports (pharmacology, toxicology, PK), and manuscripts. Proficient in developing standard operating procedures, templates, and internal guidelines for regulatory document preparation. Thorough understanding of FDA and EU GCP regulations. Management-level positions in staff development, mentoring and management of direct reports, and oversight of external writers. My colleagues know me as detail-oriented, analytical, and a clear communicator who facilitates driving results.
Alnylam Pharmaceuticals
View- Website:
- alnylam.com
- Employees:
- 2585
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Alnylam PharmaceuticalsKirkland, Wa, Us -
Principal WriterAlnylam Pharmaceuticals Feb 2024 - PresentCambridge, Massachusetts, Us -
Director, Medical WritingReplimune Oct 2023 - Feb 2024Woburn, Ma, Us -
Associate Director, Medical WritingReplimune Apr 2022 - Oct 2023Woburn, Ma, Us -
Senior Manager, Medical WritingReplimune Sep 2021 - Apr 2022Woburn, Ma, Us -
Senior Manager Medical WritingRakuten Medical Jan 2021 - Sep 2021San Diego, California, Us -
Manager Medical WritingRakuten Medical Dec 2019 - Jan 2021San Diego, California, Us -
AffiliateCascadia Drug Development Group Mar 2016 - Dec 2019Seattle, Wa, Us -
PrincipalWillis Consulting Group, Llc Nov 2014 - Dec 2019• Scientific and Medical Writing: drafting, revising, and editing scientific and medical documents (e.g. abstracts, posters, presentation slides, journal manuscripts, non-clinical study reports) for biotechnology companies, contract research organizations, research-based clinicians, and academics. • Scientific Writing Instructor: Conducted a 2-day, highly rated and proven scientific writing course teaching scientists to communicate effectively and efficiently about their research.• Biotech Consultant: Provided research support consultation services for the biopharmaceutical industry for conference coverage, target assessment, literature summaries, due diligence, and interpretation of data sets for oncology, autoimmune, and inflammatory diseases.
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Senior ScientistAmgen, Inc. Mar 2009 - Oct 2014Thousand Oaks, Ca, UsResearch project team leader and research analytics• Led 2 multi-disciplinary, multi-site, team-based projects to screen and develop large-molecule drugs for autoimmune and inflammatory indications • Provided preclinical model expertise to build therapeutic rationale for autoimmune and inflammatory diseases• Supervised and mentored 2-person teams, including associates, scientists and international PhD student interns• Led and organized multi-disciplinary working groups to develop new targets and biomarkers for lupus and COPD• Managed and analyzed complex flow cytometry and microarray data sets from mouse models of lupus and human lupus blood samples to identify new targets for treating lupus• Designed and conducted various T-cell, B-cell, and macrophage assays for target validation, drug coverage, and drug candidate screening• Designed and coordinated non-human primate studies with contract research organizations for immune challenge, arthritis, asthma, and COPD models• Initiated and coordinated contracts with vendors to obtain fresh human blood, induced sputum, and lungs for target discovery and biomarker development• Initiated and supervised several contracts with collaborators at US and European universities to test concepts and potential drug molecules using technologies outside of Amgen’s expertiseCo-instructor for Scientific Writing Course • Conceived and designed a 2-day scientific writing and reviewing course customized for Amgen Research• Coordinated and co-taught the scientific writing course for all Amgen research sites, conducting several courses per yearVoting Member of Institutional Animal Care and Use Committee • 3-site IACUC committee responsible for reviewing and approving animal use protocols, conducting vivarium quarterly inspections, and updating program guidelines -
ScientistAmgen, Inc. Jun 2004 - Mar 2009Thousand Oaks, Ca, Us• Trained and supervised peers in transgenic and knockout mouse production and maintenance of colonies• Had increasing responsibility for determining phenotypes of transgenic and knockout mice. Led team efforts to design and conduct studies to understand transgene and knockout gene effects. • Trained and mentored PhD post-docs in techniques for assessing knockout mouse phenotypes; designed and implemented in vivo and in vitro assays for assessing complex knockout mouse phenotypes• Lead biology representative on a multi-disciplinary, team-based project with responsibility to design and conduct in vivo immune challenge and autoimmunity models to validate CD30L -
Scientist/Senior Research AssociateImmunex May 1992 - Jun 2004Us• Developed new mouse embryonic stem cell lines. Cloned mouse knockout DNA constructs, screened and produced mouse embryonic stem cells to produce knockout mice.• Microinjected mouse embryos to create mice genetically deficient in novel Immunex molecules • Organized breeding schemes for double and triple knockout mouse colonies• Microinjected mouse oocytes to produce transgenic mice expressing several novel Immunex cytokines, cytokine receptors, and TNF family members• Genotyped transgenic mice, screened mice for transgene expression, and maintained breeding and production colonies of transgenic mice• Cloned and produced DNA transgenic constructs for microinjection
Cindy Willis Skills
Cindy Willis Education Details
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University Of IdahoMicrobiology And Immunology; Minor Chemistry
Frequently Asked Questions about Cindy Willis
What company does Cindy Willis work for?
Cindy Willis works for Alnylam Pharmaceuticals
What is Cindy Willis's role at the current company?
Cindy Willis's current role is Principal Writer, Medical Writing | Alnylam Pharmaceuticals.
What is Cindy Willis's email address?
Cindy Willis's email address is wi****@****gen.com
What schools did Cindy Willis attend?
Cindy Willis attended University Of Idaho.
What skills is Cindy Willis known for?
Cindy Willis has skills like Biotechnology, Immunology, Drug Discovery, Antibodies, Assay Development, Biopharmaceuticals, Life Sciences, Drug Development, Monoclonal Antibodies, In Vivo, Biomarkers, Cell.
Who are Cindy Willis's colleagues?
Cindy Willis's colleagues are John Shimkus, Bridget (Cloonan) Rothwell, Pharmd, Rph, Kristal Touchstone, Jessica Bombardier, Wihann Kotze Ca(Sa), Simona Gulli, Samip Dhakal.
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