Medical Writer - PGxHealth

Position Description

Experience

We are looking for an bright, experienced and motivated Medical Writer to:

• 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.
• 1-3 years (junior level) or 4+ years (senior level) of experience in writing clinical trial and 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.

Responsibilities

• Write and summarize the clinical and preclinical data
• Write and summarize sections of IND, CTD, integrated summaries of efficacy and safety, briefing books, overviews, and regulatory responses.
• MD/PhD/PharmD; MS/BS MA/BA Degree 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.

Qualifications
• PhD/PharmD/MS/BS/MA/BA Degree in life sciences/healthcare plus knowledge of the medical writing processes
• 4+ years medical writing experience for senior level
• Other relevant pharma/biotech industry experience
• Scientific, technical, and regulatory knowledge
Skills, Knowledge and Abilities:
• Relevant technical, computer, and word processing skills
• Work with multiple teams
• Work with multiple projects and timelines

How to Apply

Application Instructions / Send a Resume