Job Description
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.

Medical Writer

Duties and Responsibilities

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.

Background Requirements

• Education, Experience, and Knowledge
  • 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.
• Skills and Abilities
  • 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.

To apply for this position, please visit https://home.eease.com/recruit/?id=474989

 Please send resume to jobs@clda.com.

CLINICAL DATA IS AN EQUAL OPPORTUNITY EMPLOYER.