Director, Medical Writing ( Remote )
Working with the PepGen Team you will lead the development of regulatory and clinical documents, including (but not limited to) drafting scientific meeting briefing books, Protocols, Investigator's Brochures, annual reports, clinical and non-clinical reports, regulatory briefing documents, and clinical/nonclinical sections of IMPDs, INDs, CTAs, and NDAs. Your expertise and in-depth knowledge of analysis and presentation of scientific and clinical data will produce high-quality documents. As PepGen's first Full time ?Medical Writer employee, you will lead the development of Medical Writing departmental processes, procedures, and tools, providing the framework to deliver high-quality documentation. As an integrated team member, you will contribute to cross-functional working groups as needed to facilitate efficient development and finalization of regulatory and clinical documents for submissions. About The Team As a member of this team, you will feel the excitement, passion, and pure joy that comes from being part of an innovative company with a focused mission.
Skills and Competencies
Ability to be able to command the attention and lead higher level managers and senior subject matter experts.
- Proactive and be able to drive the document to its conclusion.
- You know what great medical writing looks like, leveraging your scientific knowledge, collaborative skills, and team spirit to produce high-quality strategic writing.
- You enjoy working closely with the project teams, particularly Clinical Operations, Regulatory Affairs, and clinical and nonclinical development teams, to manage all aspects of clinical/regulatory document preparation, including protocols, CSRs, Investigator Brochures, and other regulatory submission documents
Required Education and Experience
- Bachelor's degree at a minimum, preferably a PhD in a Life Science area (or equivalent experience) with 5+ years of regulatory medical writing experience.
- Outstanding written and verbal communication skills.
- Well-organized with significant knowledge of drug development,-centered research, study design, biostatistics, and the regulatory environment, with a detailed understanding of requirements for the preparation of key clinical_PR
- Independently motivated, and with good problem-sol prueba ability; able to work with multiple contributors, adjusting to the changing needs of the development programs to produce a final unified document.
About PepGen PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen's Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generatingundant a pipeline of oligonucleotide therapeutic candidates that target the crystal cause of serious diseases. For more information, visitwww.pepgen.com or follow PepGen onTwitterandLinkedIn. EEO Statement PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status. Recruitment & Staffing Agencies PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all of our recruiting needs. Thank you. Apply To this Job