Clinical Regulatory Document Writing for Submission.

Nancy Sobiek

NANCY SOBIECK
EVP, Medical Writing Services

With more than 20 years of medical writing experience under her belt, Nancy’s clients and coworkers truly believe it must be in her DNA. In fact, Nancy’s reputation for accuracy, quality and insight is well known and respected across the biotech, pharmaceutical, and CRO spectrum.

Before becoming a medical writer, Nancy worked in drug delivery formulation (Vestar, Inc.), clinical research (Vestar, Inc.), and academic research (Molecular Genetics and Immunology, California Institute of Technology).

Nancy has served as primary writer for numerous NDA, sNDA, and BLA submissions, as well as managed submission document planning and writing. She has written content that spans the library of regulatory clinical documents, including protocols, clinical study reports, briefing documents, regulatory responses, investigator brochures and/or updates, and patient narratives.

Her experience, knowledge, nuanced understanding of the most complex clinical data, and the admiration of her peers and employees has led Nancy to her current leadership role at Precise Dox.

Our mission is to consistently produce accurate and timely regulatory documents that assist Pharmaceutical and Biotech organizations in advancing patient care.

INTEGRITY is the guiding principal behind our decision-making process and the work we produce.

We value open and ongoing COMMUNICATION internally and in our client relationships.

We respect and encourage COLLABORATION within our internal organization as well as with our clients.

We have an unwavering DEDICATION to our clients to produce high-quality documents both accurately and on-time.

Our ADAPTABILITY is key to continually providing effective client support in an ever-changing regulatory environment.

As an organization, we promise to provide accurate and timely documents. Consistently.

Our passion is providing insights and solutions that help our clients avoid expensive mistakes, headaches, and delays.