Job Information
J&J Family of Companies Senior Manager, Reg Medical Writing in Spring House, Pennsylvania
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.
Johnson & Johnson Innovative Medicine discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, cardiopulmonary, and retina.
Within Integrated Data Analytics & Reporting (IDAR), the Regulatory Medical Writing team is recruiting for a Senior Manager. This position will support our immunology therapeutic area. The position may be located in Spring House, PA; Raritan or Titusville, NJ in the US; Beerse, Belgium; High Wycombe, UK; Switzerland; and Canada. 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 Responsibilities:
This position will manage a pool of internal writers and will lead early development writing projects. The successful candidate:
Directly leads or sets objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
Is the primary point of contact for MW activities in early development for the cross-functional team (eg, nonclinical, clinical).
Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
Establishes and drives document timelines and strategies independently.
Guides or trains cross-functional team members on processes and best practices.
Proactively identifies and champions departmental process improvements.
May develop and present best practices or innovations to internal or external audiences.
May lead cross-functional, cross-TA, or cross-J&J process improvement initiatives.
Leads discussions in MW and cross-functional meetings as appropriate (eg, global program team meetings, study team meetings, clinical team meetings).
Maintains and disseminates knowledge of industry, company, and regulatory guidelines.
Completes all time reporting, training, metrics database, and project tracking (functional planning) updates as required in relevant company systems.
Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed.
Interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.
May represent MW in industry standards working groups.
As a people manager:
Supervises/manages and is accountable for direct reports.
Sets objectives and agrees on goals for direct reports. Provides performance oversight, including feedback on performance and development.
Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
Ensures direct report’s adherence to established policies, procedural documents, and templates.
Participates in hiring and onboarding.
Qualifications
Education:
- University/college degree required. Masters or PhD preferred.
Experience and Skills:
We would value a colleague with these qualities:
At least 10 years of relevant pharmaceutical/scientific experience is required.
At least 8 years of relevant medical writing experience is required.
As a people manager, at least 2 years of people management experience is preferred.
Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently is required.
Resolves complex problems independently.
Advanced knowledge and application of regulatory guidance documents such as ICH requirements is required.
Interacts with senior cross-functional colleagues and external partners, often requiring coordination across multiple functions and groups is required.
Proactively identifies potential risks and develops strategies to mitigate.
Identifies and resolves problems related to development and implementation of new service offerings/deliverables.
Ability to serve as the liaison between team members and senior leadership within a therapy area.
Excellent oral and written communication skills.
Attention to detail.
Expert time management for self, direct reports, and teams.
Expert project management skills, and project/process leadership.
Strong people management and leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
Ability to delegate responsibility to junior writers is required.
Ability to lead by example, stay focused and positive, and act with integrity is required.
Ability to act as change agent and adapt to rapidly changing organizational & business challenges is required.
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.
The anticipated base pay range for this position is 137000 to 235750.
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)).
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 of Work, Personal and Family Time - up to 40 hours per calendar year
Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits
The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired outside the United States will be eligible for compensation and benefits in accordance with their local market.