The Global Head of Submissions (GHS), Global Toxicology, in Nonclinical Safety (NCS) supports the development of novel therapeutics spanning all therapeutic areas and modalities through leadership of a global team with two groups of nonclinical scientific writers and document analysts, located in Beerse (Belgium) and Raritan (New Jersey). The GHS assures that contributions of NCS to Janssen R&D (JRD) submission documents, such as IB, IND/IMPD, CTA, NDA, BLA, briefing books etc are delivered in time, with excellent and consistent quality and in line with internal and external guidelines. The GHS assures that his/her team is seamlessly and globally connected, and efficiently managed, with a strong collaboration with relevant functions within NCS and JRD.
The GHS will manage a global group of nonclinical scientific writers and document analysts, overseeing all documented interactions with regulatory authorities for the complete portfolio in JRD. The GHS has responsibility for career and talent development, as well as succession planning, to create a team that can deliver the diverse and broad portfolio on short and long term. He/she has accountability for globally improving and aligning the documentation for regulatory authority interactions, in particular processes related to submission of nonclinical documents and electronic files, assuring optimization of people resources, capacity planning, tracking and follow-up of major milestones and timeline commitments.
He/she assures that highly complex nonclinical data are effectively presented and communicated in regulatory documents in a consistent manner and in sync with contributions from other functional areas, leading to high quality deliverables that are in compliance with regulations and best practices in medical writing. He/she will work in close collaboration with regional NCS submissions teamleader(s), NCS Therapeutic Area Leaders, Nonclinical Safety Leads (NCSLs), and other relevant global roles. Additionally, the GHS is interfacing with peers in relevant JRD departments, such as Discovery, DPDS, Clinical and Regulatory departments.
The Senior Director has a desire for teaching, learning, and innovation and continue career development through participation in and presentations at regulatory meetings and/or scientific pharma/industry meetings.
This role is pivotal in assuring a globally integrated, modality independent regulatory submissions strategy within NCS, enabling high quality and timely delivery, with direct impact on timelines and quality of global submissions in the JRD portfolio. The GHS may also serve as NCSL for compounds in development or as regional leader of a submissions group.
The Senior Director will be responsible for documents required for global regulatory interactions being delivered with high quality, consistency and maximal efficiency, in close collaboration with various functions within NCS and JRD. Ensures clarity of communication of cohesive stories in those documents.
They will assure close collaboration with relevant functions, in particular with peers, NCSLs, NCS Therapeutic Area Leaders and NCS functional area leaders, as well as other JRD departments involved in regulatory submissions. Strong understanding of regulatory, DPDS and other relevant organizations to facilitate proper interface and effectiveness of collaborative and consulting partnerships. Engages external network to inform submission strategies. Ensures compliance with global regulations.
This position will be a people leader role for a global organization of scientific writers and document analysts, including hiring, managing and developing staff, succession planning, optimal and global resourcing, as well as coaching of relevant NCS personnel in growing medical writing skills and soft skills.
- Master degree or Ph.D. degree in a relevant medical sciences / life sciences area, with 15 + years of experience in pharmaceutical industry, in particular scientific writing and/or project management, preferably in the Nonclinical Safety area.
- Proven track-record in leading teams, including direct people management
- Experience with verbal and non-verbal interactions with regulatory authorities and excellent knowledge of the regulatory landscape. Proven excellence in scientific writing skills.
- Exceptional diplomacy and communication skills
- Clear attention for detail, preferably experience with Good Laboratory Practices
- Strong ability to work effectively in a collaborative and global environment
United States-New Jersey-Raritan, United States-Pennsylvania-Spring House
Janssen Pharmaceutica N.V. (7555)