Lead Scientist, Module 3 Dossier Development
Location: Hull, UK
Reports To: Manager, Module 3 Dossier Development
Indivior is a global specialty pharmaceutical company working to help change patients' lives by developing medicines to treat substance use disorders (SUD) and serious mental illnesses.
POSITION SUMMARY:
Scientific writer working in the Module 3 Dossier Development function of the R&D CMC (Chemistry, Manufacturing and Controls) team to write, review and approve Module 3 documentation (CTD, IMPD, IND, NDA, ASMF and DMF), supporting the development and maintenance of new and existing dossiers for projects from Phase 1 inception through to the post-approval phase.
ESSENTIAL FUNCTIONS:
* Support the creation and maintenance of chemistry, manufacturing and controls information in Module 3 dossiers (CTD, IMPD, IND, MAA, NDA, ASMF and DMF), including Module 2.3 QOS, covering drug substance and drug product.
* Write, review and approve regulatory submission documents and prepare responses to questions raised by Healthcare Authorities.
* Support CMC changes in response to Regulatory Intelligence.
* Support CMC aspects of Change Control for existing Licences.
* Take ownership of projects assigned to you, ensuring project milestones are delivered on time and to plan.
* Maintain a strong working knowledge of ICH guidelines, EMA and FDA guidance for industry and local regulations, applying these principles in all aspects of your role.
* Actively participate in Module 3 strategy and planning meetings, risk assessments and stakeholder interactions to leverage your technical and regulatory expertise and insight, to drive the right decisions at the right time and mitigate risk.
* Liaise with 3rd parties, global regulatory, local regulatory, QA, Supply, and other relevant functions to support delivery of Module 3.
* Proactively contribute to the continuous improvement of the CMC function with respect to new technologies and processes.
MINIMUM QUALIFICATIONS:
Education: Bachelor’s degree or higher in Chemistry or related relevant science.
Experience: 5-10+ years’ experience of scientific writing and/or reviewing Module 3 dossiers in CTD format.
Computer Skills: Proficient in basic computer applications such as Microsoft Word, Outlook, PowerPoint, Excel.
COMPETENCIES/CONDUCT:
* A ‘See it Own it Make it Happen’ attitude and proven ability to take calculated risks.
* Working in a challenging, fast-paced environment, on varied projects.
* Working cross-functionally to ensure that projects are delivered to the highest quality in accordance with global and regional regulatory best practice.
* Technical problem solving and troubleshooting when required ensuring issues are addressed without delay to projects.
* The ability to think laterally in order to apply novel solutions and supporting justifications to challenging problems or situations.
PREFERRED QUALIFICATIONS:
2.1 or 1st class degree preferred.
PREFERRED EXPERIENCE:
* Drug substance requirements, eg, ASMF/DMF.
* Global market requirements, especially US, Europe, Canada.
* Use of Veeva, D2 or similar document management system.
BENEFITS:
* 25 days holiday plus public holidays.
* Flexible working; core hours are 10am-3pm, and we offer up to 2 days working from home/week for office-based roles.
* Paid Volunteer Time Off.
* 10% company pension.
* EAP service including Legal, Health and Wellbeing support.
* Optional Health Insurance with BUPA.
* Company Death in Service and Payment Protection Insurance.
* 3 Celebratory days.
* Access to platform for discounts on gym membership, shopping, holidays.
Travel: Little to no travel required.
EQUAL EMPLOYMENT OPPORTUNITY: EOE/Minorities/Females/Vet/Disabled.
About Us
Passion. Innovation. Achievement. All are key aspects of a career with Indivior. We are a worldwide family of individuals with varying backgrounds, strengths, and weaknesses united under one common purpose – the patient.
#J-18808-Ljbffr