Lead Scientist, Module 3 Dossier Development

TITLE:

Lead Scientist, Module 3 Dossier Development

Title: Lead Scientist, Module 3 Dossier Development

Reports To: Manager, Module 3 Dossier Development

Location: Hull, UK

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. The name is the blend of the words individual and endeavor, and the tagline “Focus on you” makes the company’s commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction and mental illness.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. Our vision is that all patients around the world will have access to evidence-based treatment for the chronic conditions and co-occurring disorders of SUD. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. Building on its global portfolio of opioid use disorder treatments, Indivior has a pipeline of product candidates designed to both expand on its heritage in this category and potentially address other chronic conditions and co-occurring disorders of SUD, including alcohol use disorder and cannabis use disorder.

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:

The responsibilities of this job include, but are not limited to, the following:

• 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

MMINIMUMField of Study: Chemistry or related relevant science

Industry: Life sciences

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.

License/Certifications: Not applicable

COMPETENCIES/CONDUCT

In addition to the minimum qualifications, the employee will demonstrate:

• 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 practise
• 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:

Experience in the following areas is beneficial:

• Drug substance requirements, eg, ASMF/DMF
• Global market requirements, especially US, Europe, Canada
• Use of Veeva, D2 or similar document management system

BENEFITS:

Indivior is committed to providing a culture driven by guiding principles and top-tier benefits that match the importance of the work we do. The Indivior experience includes

• 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, as well as a flexible Friday programme, subject to completion of contractual hours.
• 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 such as gym membership, shopping, holidays
• Our Guiding Principles, Core Values and Vision provide a culture that unites and guides our employees.

Travel: Little to no travel required

GUIDING PRINCIPLES:

Indivior’s guiding principles are the foundation for each employee’s success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

COMPLIANCE OBLIGATIONS:

Indivior is committed to maintaining a workplace where employees are committed to compliance and feel comfortable raising concerns about potential violations of policies or unethical behaviour. As part of your responsibilities, you are expected to:

Employee Obligations:

• Always act with honesty and integrity.
• Risk IQ: Know what policies apply to your role and function and adhere to them.
• Speak Up: If you see something, say something.

Manager Obligations:

• Always act with honesty and integrity
• Reinforce risk awareness with your team, with accountability and oversight for ongoing review and mitigation.
• Model and reinforce a Speak Up culture on your team.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled