Director, Regulatory Medical Writing, Oncology - 2406201503WDescriptionDirector, Regulatory Medical Writing, OncologyAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/Johnson & Johnson 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.Are you ready to join our team? Then please read further!Key ResponsibilitiesOversee the strategic direction and resourcing for all solid-tumor targeted therapy program writing in the Oncology Therapeutic Area.
Work with key cross-functional stakeholders in the Oncology Therapeutic Area to ensure that documents within the solid tumor targeted therapy programs are delivered efficiently, on time, and with high quality.
Prepare and finalize all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Work with a high level of independence and take a lead role on assigned projects with respect to timing, scheduling, and tracking.
Able to lead program-level/submission/indication writing teams independently.
Directly lead or set objectives for others on team projects and tasks.
Guide or train cross-functional team members on processes, best practices; coach or mentor more junior writers.
Proactively identify and champion Medical Writing process improvements.
Able to develop and present best practices to external audiences.
Able to lead cross-functional/cross-TA, cross-J&J process improvement initiatives, or other process working group.
Able to represent the Medical Writing department with decision-making authority in R&D business organization with guidance from Therapeutic Area Head or Functional Area Head.
Responsible for providing guidance on deliverables and content.
Lead discussions in Medical Writing and cross-functional meetings as appropriate.
Maintain and disseminate knowledge of industry, company, and regulatory guidelines.
Interact with senior cross-functional colleagues and external partners to strengthen coordination between departments.
Able to represent Medical Writing in industry standards working groups.
Manage direct reports in Medical Writing. Set objectives for individual team members. Regularly meet with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Able to make decision on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, lead in goal-setting and performance discussions.
QualificationsQualificationsEducation:
University/college degree required. Masters or PhD preferred.
Experience and Skills:We would value a colleague with these qualities:
At least 14 years of relevant pharmaceutical/scientific experience; at least 12 years of relevant regulatory medical writing experience is required!
At least 5 years of people management experience required
Strong oral and written communication skills.
Expert project management skills, expert project/process improvement leadership.
Expert leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management). Expert people management skills.
Ability to delegate responsibility to junior writers.
Expert ability to motivate and develop best in class talent pipeline.
Demonstrated ability to collaborate and develop effective partnerships with key business partners and customers.
Ability to recognize how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
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.For United States Applicants only:The anticipated base pay range for this position is $200,600 to $271,400.The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation’s performance over a calendar/ performance year. Bonuses are awarded at the Company’s discretion on an individual basis.Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.Employees may be eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).US Employees are eligible for the following time off benefits:
Vacation - up to 120 hours per calendar year
Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
Holiday pay, including Floating Holidays - up to 13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefitsThe compensation and benefits information set forth in this posting applies to candidates hired in the United States only. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.Primary Location Europe/Middle East/Africa-United Kingdom-England-High WycombeOther Locations NA-US-New Jersey-Titusville, Europe/Middle East/Africa, NA-US-New Jersey-Raritan, Europe/Middle East/Africa-Belgium-Antwerp-Beerse, NA-Canada, Europe/Middle East/Africa-Netherlands-South Holland-Leiden, NA-US-Pennsylvania-Spring HouseOrganization Janssen Cilag Ltd. (7360)Job Function Medical WritingReq ID: 2406201503W