What are the responsibilities and job description for the Director, Medical Writing (Remote) position at OSI?
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.
The full job description covers all associated skills, previous experience, and any qualifications that applicants are expected to have.
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 TeamAs 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 CompetenciesAbility to command the attention and lead higher level managers and senior subject matter experts.Proactive and 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, clinical research, study design, biostatistics, and the regulatory environment, with a detailed understanding of requirements for the preparation of key clinical and regulatory documents.Independently motivated, and with good problem-solving ability; able to work with multiple contributors, adjusting to the changing needs of the development programs to produce a final unified document.About PepGenPepGen 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 generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit or follow PepGen on Twitter and LinkedIn.
EEO StatementPepGen 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.
J-18808-LjbffrRemote working / work at home options are available for this role.
