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, 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.
Interested applicants should apply via the PepGen Careers page
https://www.pepgen.com/careers/. Please do not apply via the LinkedIn page.
About PepGen
We are a biotechnology company advancing next-generation oligonucleotide therapies for neuromuscular diseases. Our ambition is to unlock the potential of nucleic acid therapeutics by leveraging the drug delivery capabilities of our proprietary Enhanced Delivery Oligonucleotide (EDO) platform. We are applying this technology across a wide range of indications and are rapidly growing our team at our U.S. headquarters in Boston, Massachusetts.
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.
Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.
Recruitment & Staffing Agencies: PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.
