Manager, Dossier (CTD) Development
Title: Manager, Dossier (CTD) Development
Location: Fort Collins, CO or Richmond VA
POSITION SUMMARY: An experienced technical Dossier (CTD) Development writer within R&D CMC (Chemistry, Manufacturing and Controls) to support the development of new and existing projects. This Dossier (CTD) Development person is responsible for the generation, ownership and oversight of the Module 3 (and M2 QoS) throughout its lifecycle from Phase 1 inception through to post approval lifecycle management. This person will work with functional teams in the preparation and review of CMC technical documents (including, but not limited to, formulation development/analytical protocols and reports, research proposals, summaries, INDs, NDAs, Annual Reports).
ESSENTIAL FUNCTIONS: The responsibilities of this job include, but are not limited to, the following:
- Manage the Dossier (CTD, IMPD, IND, NDA, ASMF and DMF) for Indivior R&D Fort Collins (FC) supporting global Module 3 development, including M2 QoS, covering Drug Substance and Drug Product development, for both internal and external (3rd party) developments
- Lead M3 activities within the new and existing substance and product pipeline, ensuring the documentation of all technical aspects of the development are of the highest quality and with any issues highlighted to stakeholders in a timely manner.
- Develop and maintain M3 documents from first phase IND/IMPD in accordance with global and regional regulatory best practise through to post approval lifecycle management
- Provide support to Global CMC R&D teams by providing templates, oversight, guidance and training
- Take ownership of projects assigned to you, ensuring project milestones are delivered on time and to plan.
- Actively participate in M3 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.
- Write M2 QoS to support Global R&D
- Apply the principles of Quality by Design and ensure that these are appropriately documented in 32S26 and 32P2 in accordance with current regulatory expectations
- 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 and throughout your team
- Manage processes and procedures associated with all aspects of Dossier quality
- Liaise with 3rd parties, global regulatory, local regulatory, QA, Supply, and other relevant functions to deliver projects.
- Help functional leads in the review and approval of regulatory submissions documents and help prepare responses to questions raised by Healthcare Authorities, for both internal and external (3rd party) developments
- Set up system for collection of comments, support the operation of the review process and creates updated draft for next phase review
- Collaborate with internal functional areas and external partners to ensure the production and review of CMC documents within agreed upon timelines
- Overtime, hire and develop a small team to perform functional activities listed above. To include prioritization, time management, delegation, performance reviews and setting objectives for personal and professional development
Education: Bachelor’s Degree in scientific discipline required.
- Demonstrated CMC technical writing skills with at least 10 years of pharmaceutical industry experience in pharmaceutical manufacturing or development and regulatory submissions is required.
- Familiarity with ICH and FDA guidelines, drug development and approval process, GMP and quality compliance requirements preferred.
- At least 10 years of pharmaceutical industry experience in Regulatory CMC
- Management experience of people and projects in a fast paced GMP development environment
- Proven track record of delivering high quality work to tight deadlines.
- A thorough understanding of various technical documents in the process of writing, reviewing, editing or constructively critiquing a document.
Computer Skills: Experience with Microsoft programs and electronic document management systems.
License/Certifications (recommended, not required):
- American Medical Writers Association Certificate preferred (Essential Skills and/or Regulatory and Research Certificates)
- Medical Writer Certified
In addition to the minimum qualifications, the employee will demonstrate:
- Excellent collaboration skills with ability to plan and prioritize projects to meet aggressive timelines.
- High proficiency towards detail, with strong proofreading/editing skills and ability to detect inconsistencies.
- The ability to perform follow-up to ensure actions are completed.
- Work toward goals that benefit the team, which includes contributing ideas and participating in team activities appropriately.
- Excellent verbal and writing communication skills with extremely high attention to detail and accuracy.
- Well-organized with the ability to handle multiple tasks independently and manage competing priorities.
- Strong analytical skills with the ability to think strategically, develop tactics and transform ideas into reality.
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.
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