PGxHealth is an emerging pharmaceutical and biomarker company that possesses a solid product pipeline including one drug candidate for which an NDA is being filed, a second Phase III drug, a solid Rx and Dx pipeline, experienced management team and Board of Directors,  and an active M&A and Licensing  pipeline.

Company desires an individual with:

We are a rapidly growing small pharmaceutical company looking for an experienced Medical Writer to come in and serve as a high-level writer as well as cross-functional document quality manager. This is an entrepreneurial company.  We are very competitive with compensation and benefits.

• Prepare of Protocols, Investigator Brochures, Clinical Study Reports (CSRs), clinical sections of the CTD, integrated summaries of efficacy and safety, briefing books, overviews, and regulatory responses.
• Supervise the work performed by CRO and/or consultant writers.
• Manage the medical writing activities and QC of external writers with regards to company document uniformity and publication standards.
• Serve as the liaison between internal and external reviewers and the external writers.
• Work with Clinical Operations in managing documents quality through the review process and updates from protocol synopsis to final CSR.
• Assist document approvers to provide electronic signatures.
• Participate in appropriate timeline development, internal strategy, and operations or regulatory meetings.
• Check electronically published CSRs for completeness and adherence to company’s electronic publishing standards before archiving.

Requirements:

• MD/PhD/PharmD. MS/BS or MA/BA will be considered with a higher level of industry experience.
• 4-10 years of experience in writing regulatory documents, CSRs, clinical sections of the CTD in the pharmaceutical or CRO environment required.
• Ability to interpret and organize scientific data and general understanding of clinical research, biostatistics, electronic publishing, and relevant industry guidelines (GCP, eCTD, and ICH).
• Marketing submission experience (NDAs or MAAs) preferred. 

·         MD/PhD/PharmD; MS/BS MA/BAdegree in life sciences/healthcare is desirable.

·         4+ years medical writing experience other relevant pharma industry experience combined with scientific and regulatory knowledge, plus knowledge of the medical writing processes.

PGxHealth is proud to be an Equal Opportunity Employer.