- Effectively partner cross-functionally in the planning, drafting, editing and reviewing of high quality technical documents to support regulatory submissions.
- Coordinate with external collaborators and CROs to manage the compilation and approval of research, developmental, analytical and pre-clinical related documents and reports.
- Work effectively with company document management system and related tools, templates and procedures in order to ensure efficient production of documents which complies with applicable regulatory requirements, SOPs, and company standards.
- Work with relevant teams to obtain accurate information and data for written materials and ensure consistency of facts and style within and across documents as feasible and appropriate, including but not limited to review of text, tables, and figures for accuracy, logic, and clarity of presentation.
- Maintain scientific knowledge of Replimune’s viral products and the parent wild type virus, analytical methods and projects and current relevant regulations.
- Drafts and develops documents, which may include but are not limited to analytical development reports, characterization reports, process development reports, product comparability, product sequencing reports, regular environmental, safety and quality reviews, manufacturing batch analysis, analytical specification reports and scientific and CMC literature searches.
- Assists with the techinal review of regulatory submissions and responses to regulatory agencies, e.g. FDA, MHRA etc.
- Perform format and/or content quality control (QC) review of technical documents produced by the development functions to ensure accuracy and consistency.
- Exceptional technical writing capability and an ability to convey and summarize complex technical data and analyses in a clear and concise manner.
- Documented excellence in advanced features of Microsoft Word and ability to work effectively with a document management system.
- Working knowledge of ICH and US regulatory requirements is desired.
- Excellent interpersonal skills, abilty to develop important relationships with key stakeholders and to work both independently and collaboratively with a team in a geographically dispersed environment.
- Must thrive working in a fast-paced, innovative environment while remaining flexible proactive, resourceful and efficient.
- Strong project management skills in guiding and working with cross-functional representatives through the composing or updating technical documents in a timely and high-quality manner.
- Experience in successfully resolving conflicting editorial opinions expressed by team members.
- MSc or PhD in Virology, Immunology or a related field is required.
Experience and Skill Requirements:
- Strong demonstratable background in virology or gene therapy, with an in-depth knowledge of Herpes Simplex Virus an advantage.
- Has at least 5 years relevant experience in biotechnological or pharmaceutical scientific writing and a history of prior meaningful participation in regulatory submissions or publications in high-impact scientific journals.
- Understanding of biotechnological analytical and process techniques is advantageous e.g. chromatography, ELISA, SDS-PAGE, cell-based assays, PCR.
Replimune is an equal opportunity employer.
EEO & Employment Eligibility
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition. Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.
Replimune now requires Covid vaccination disclosure for all US employees.