Director, Regulatory Medical Writing, Oncology At Johnson & Johnson, we believe health is everything.
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Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, pulmonary hypertension, and retinal disease.
We are recruiting for a Director to join the Regulatory Medical Writing team to support the Oncology therapeutic area.
The position may be located in High Wycombe in the UK; Raritan or Titusville, NJ, or Spring House, PA in the US; Beerse, Belgium; Canada; or Leiden, Netherlands.
Other locations may be considered.
Remote work options may also be considered on a case-by-case basis and if approved by the business.
Position Summary This position is accountable for setting the strategy and operational execution for the Prostate/Solid Tumor Targeted Therapy portfolio within the Oncology Regulatory Medical Writing team, in close consultation and accordance with the RegMW Oncology TA Head and in line with R&D priorities, Therapeutic Area objectives, and IDAR/GD strategic imperatives.
Recognized expert medical writer for any documents within and across therapeutic areas.
Partners in close collaboration with leadership across GD, the TAs, and the overall R&D organization to provide high quality deliverables successfully and efficiently.
Influences key senior stakeholders across these organizations to align on best strategies and tactics to deliver efficient and successful deliverable submission.
Accountable for the Prostate/ST3 Disease Area medical writing resource management and allocation.
Accountable for process compliance aspects for the sub-Therapeutic Area's work.
Can represent the RegMW Oncology TA Head or department at high-level and cross-functional TA meetings and has significant independent decision-making authority.
Can step in for the RegMW Oncology TA Head in case of absence.
Contributes to and champions internal metrics, regulatory, and publishing guidelines as well as improvement of internal systems, tools, and processes.
Works within the RegMW OLT to identify and promote cross-TA resource sharing and development opportunities.
This position will report to the RegMW Oncology TA Head and will ensure the execution of the RegMW mission.
Principal Responsibilities Works closely with key functional stakeholders in the Oncology TA and Delivery Unit to drive RegMW strategy and tactics as needed to optimize ways of working.
Leverages the strategy and direction of specific Disease Area Regulatory Medical Writing in line with RegMW, IDAR, GD, and TA-specific objectives.
Oversees adequate resource planning, prioritization, and allocation to ensure programs and projects within the Disease Area are optimally supported.
Ensures, with the RegMW Oncology TA Head, that the RegMW strategy and processes are clear towards all stakeholders by organizing clear and consistent communication around it.
Able to represent RegMW department with decision-making authority in R&D business organization with guidance from TA/FA Head or Global Head of RegMW.
Ensures timely and high-quality delivery of departmental deliverables.
Leads the development and consistent implementation of RegMW processes.
Ensures group compliance to departmental, company and industry policies and requirements.
Helps RegMW Oncology TA Head align RegMW processes and priorities to maximize RegMW and IDAR's effectiveness; helps design and implement innovative approaches to enhance productivity and effectiveness.
Drives adherence to standards in trials/programs and regulatory submissions.
Oversees initiatives related to process improvements, regulatory compliance and other key department, cross-functional activities as assigned.
Participates in and/or leads cross-functional and cross-sector initiatives.
Contributes to development and analysis of performance metrics to help identify ways to raise department standards.
Drives the sourcing strategy for the Disease Area in conjunction with the RegMW Oncology TA Head and identifies needs for external vendor support.
Provides leadership to the Disease Area by helping attract and retain top talent, developing team members, and ensuring organizational effectiveness, transparency, and communication.
These positions are responsible for creating an environment where employees feel engaged and empowered, and take pride in their role, responsibilities, and deliverables.
Qualifications A university/college degree in a scientific discipline is required plus at least 14 years of relevant pharmaceutical/scientific experience.
An advanced degree (e.g., MS, PhD, MD) is preferred.
At least 12 years of relevant medical writing experience is required.
At least 5 years of people management experience is required.
Qualities and Characteristics Ability to lead in a team environment.
Expert time management for self, direct reports, and teams.
Builds and maintains solid and productive relationships with cross-functional team members.
Expert project management skills, expert project/process leadership.
Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
Ability to delegate responsibility to junior writers.
Expert people management skills.
Expert ability to lead and influence by example and stay focused (positive).
Demonstrate integrity and be a change agent.
Expert ability to motivate and develop best in class talent pipeline.
Demonstrated ability to collaborate internally and develop effective partnerships with key business partners and customers.
Creates a positive Credo-based work environment for staff members.
Shows openness to new ideas and fosters organizational learning.
Acts as change leader, and drives adaptation to rapidly changing organizational & business challenges within the TA or sub-function.
Expert knowledge and application of regulatory guidance documents such as ICH requirements.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.
Please contact us to request accommodation.
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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