Biotech/Pharmaceutical

Contract Medical Writer – Remote

Contract

Penfield Search Partners

Contact: Neisha Camacho/Terra Parsons – teamnt@penfieldsearch.com

Job Description:

  • Directs and provides technical and operational support to the activities of the medical writing staff and associated projects. This includes, but is not limited to: directing, authoring, editing and providing input to clinical documents, documents required for regulatory submissions to USA and other global health authorities, presentations, posters, publications and regulatory fulfillment.
  • Manage teams and medical writing projects. Oversee and review work of internal and outsourced medical writing teams for accuracy, quality, clarity, consistency of scientific content and alignment with company position. Contribute strategically and scientifically at the project and/or study team level.
  • Authors and/or review clinical and regulatory documents across clinical programs, including but not limited to clinical study reports, protocols/protocol amendments, briefing packages, investigator brochures, clinical summaries for marketing applications, and responses to queries from regulatory authorities under strict timelines. Work closely with study teams to ensure that documents are scientifically accurate, internally consistent, and meet intended purpose. Act as a subject matter expert on internal standards and external regulatory guidelines.
  • Collaborate on the development of clinical documents in accordance with all applicable regulations Good Clinical Practice (GCP), applicable regulatory requirements and guidance documents (e.g., 21 CFR Parts 312 and 314, European Medicines Association (EMA) Clinical Trials Directives, International Congress on Harmonisation (ICH) guidelines) company Standard Operating Procedures {SOPs) and internal style guides, as appropriate.
  • Lead and collaborate with cross-functional team members (Clinical Operations, Clinical Development, Pharmacology, Biometrics, Pharmacovigilance, Regulatory affairs, Quality, and CMC) to develop strategy and timelines to ensure accurate and timely completion/delivery of high-quality, scientifically justified documents.
  • Contribute to departmental SOPs and/or co-lead process improvement activities within and across functional areas that support medical writing activities (including Work Instructions, Style Guides and Templates).
  • Implements document quality controls, standards and best practices Process and Resource Management, assist with quality control (QC) and “peer” review of clinical study reports and other submission documents as needed.
  • Assist in day-to-day operational activities and other assignments as needed and specified by management.

Qualifications:

  • Advanced degree preferred (PhD or PharmD) with at least 5 years’ experience writing and managing regulatory documents in pharmaceutical industry OR Master’s degree in a scientific discipline with 6+ years of experience in a pharmaceutical, biotechnology, contract research company (CRO)
  • Experience with outsourcing and external vendors to manage and prioritize assignments to ensure timely completion of high quality documents.
  • Prior experience in Oncology/hematology therapeutic area desired.
  • Knowledge of eCTD requirements and submissions to the US FDA (NDA, BLA) and EMA (MAA) and ICH guidelines. Familiarity with regulatory submission documents such as INDs, NDAs, MAAs, PIPs and BLAs
  • Must be a team player with strong written and verbal communications, analytical and problem-solving skills
  • Ability to work with complex projects and within cross-functional teams
  • Expert knowledge of AMA style, medical terminology, and clinical data analysis
  • Proficiency in computer skills including Microsoft Office (Word, Excel, PowerPoint, Outlook) and familiarity with SharePoint
  • Excellent attention to detail, including fact checking, logical flow, parallelism, formatting, and document structure.
  • Excellent leadership, communication, interpersonal and influencing skills; ability to negotiate well and build good relationships with coworkers
  • Ability to manage change successfully and experience in process improvements
  • Ability to enact change and foster an innovative atmosphere

Tagged as: Contract Medical Writer - Remote