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
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
