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Job Information

J&J Family of Companies ASSOC. DIR., REGULATORY MEDICAL WRITING in Spring House, Pennsylvania

Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for an Associate Director Medical Writer in the Titusville, New Jersey area, Europe, or Canada. Remote work options may be considered, on a case-by-case basis and if approved by the Company!

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, hematology, immunology, neuroscience, infectious diseases, cardiovascular, metabolic, mental health, and pain management, and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

Position Summary:

  • Leads in a team environment and matrix.

  • Contributes to and champions internal standards, regulatory, and publishing guidelines.

  • Contributes to and champions the improvement of internal systems, tools, and processes.

  • Able to prepare complex documents within and across therapeutic areas (TAs) (see examples under "principal responsibilities") independently.

  • Able to function as a lead writer on any compound independently.

  • Able to lead process working groups.

  • Leads in setting functional tactics/strategy.

  • Leads TA-level strategy (e.g., submission team, global program team, clinical team).

  • Able to oversee the work of external contractors. Can represent TA head at high-level and cross-functional TA meetings and has some independent decision-making authority.

  • May have additional major responsibility with supervision: o Cross-functional, cross-TA, cross-J&J initiative/collaboration (e.g., leadership of Community of Practice) o Larger organizational responsibility (e.g., manage a subset of TA org).

    Principal Relationships:

  • Functional Contacts Inside the Company (as collaborator and peer): Reg MW leadership team, manager, peer writers. Employees from other departments such as Global Development, Quantitative Sciences, Bio Research Quality & Compliance; TA staff (Clinical), Regulatory Affairs, GMS, PMO, Clin Pharm, Human Resources; Finance, Information technologies, Janssen R&D Procurement, and External Alliances.

  • Contacts Outside the Company: May oversee day-to-day project-related work of contractors or external service providers as needed. May collaborate with external partner company staff on codeveloped compounds.

  • Supervision (direct): Direct reports (if applicable), and others as assigned.

    If a People Manager:

  • Manage a team of internal medical writers (direct reports).

  • Supervises/manages others on the team. Sets objectives for individual team members.

  • Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.

  • Accountable for compliance aspects of direct reports' work.

  • May lead in resource management and actively participate in hiring decisions.

  • May make decisions on hiring staff, onboarding new staff, conducting career and talent development discussions for staff, leads in goal-setting and end of year calibration reviews and performance discussions, and contribute to compensation planning.

  • Regularly meets with manager, mentors, and external vendors. Attends departmental meetings.

  • Leads discussions in Medical Writing and cross-functional meetings as appropriate (eg, submission team meetings, GPT meetings, study team meetings, clinical team meetings).

  • Maintains and disseminates knowledge of industry, company, and regulatory guidelines.

  • Leads process working groups

  • Completes all time reporting, training, metrics database, and project tracking (functional planning) updates as required.

  • Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed.

  • If applicable, has lead MW responsibilities for providing guidance on deliverables, content, etc.

  • Interacts with senior cross-functional colleagues and external partners to strengthen coordination between departments.

  • May represent medical writing in industry standards working groups.

  • If applicable, ensures staff's adherence to established policies, procedural documents, and templates.

  • If applicable, frequent engagement with staff and leading discussions on employee development and talent management.

  • If applicable, performance oversight and development, as well as accountability for direct reports.

  • May serve as Sponsor for internal initiatives/Communities of Practice.

    Responsibilities:

  • Prepares and finalizes all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.

  • Leads in a team environment. Works with a high-level of independence and takes a lead role on assigned projects with respect to timing, scheduling, and tracking.

  • Directly leads or sets objectives for others on team projects and tasks, eg, able to lead process working groups or Communities of Practice.

  • Guides or trains cross-functional team members on processes, best practices; coach or mentor more junior writers.

  • Able to lead compound/submission/indication/DAS writing teams independently.

  • Proactively identifies and champions departmental process improvements.

  • May develop and present best practices to external audiences.

  • May lead cross-functional/cross-TA, cross-J&J process improvement initiatives.

    If a Lead Writer:

    Responsibilities (not limited to):

  • Primary point of contact for Clinical/Global Program Team for medical writing activities.

  • Responsible for functional planning and metrics database updates for assigned program.

  • Responsible for championing Reg MW best practices on assigned program.

  • Responsible for setting strategy and leading writing group on health authority submissions.

Qualifications

Education and Experience Requirements:

  • A university/college degree is required plus at least 12 years in relevant pharmaceutical/scientific experience. An advanced degree (eg, Masters, Ph.D., MD) is preferred.

  • At least 10 years of relevant medical writing experience is required.

  • At least 2 years of people management experience if a people manager.

  • Experience in project management and process improvement is required.

    Other: Decision Making and Problem Solving:

  • Recognizes how to best interpret, summarize and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.

  • Responsible for establishing and driving document timelines and strategies independently.

  • Resolves complex problems independently.

  • May assign projects and resolve issues with writing team members.

  • Interacts with senior cross-functional colleagues and external partners, often requiring coordination across multiple functions and groups.

  • If applicable as manager of direct reports, lead discussions about direct report goal-setting, performance evaluations and ratings, promotions, salary adjustments, in close interaction with TA head.

  • Proactively identifies potential risks and develops strategies to mitigate.

  • Identifies and resolves problems related to development and implementation of new service offerings/deliverables.

  • May interact at a cross-company or cross-pharma level.

  • May serve as the liaison between team members and senior leadership within a TA. Qualities and Characteristics:

  • Excellent oral and written communication skills

  • Attention to detail

  • Ability to lead in a team environment

  • Expert time management for self, direct reports (if applicable), and teams

  • Builds and maintain 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

  • Strong people management skills

  • Ability to lead by example, stay focused and positive, and act with integrity

  • Strong influencing skills on teams and individually

  • Ability to internalize and teach CREDO behaviours

  • Acts as change agent, and adapt to rapidly changing organizational & business challenges

  • Advanced knowledge and application of regulatory guidance documents such as ICH requirements

    Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.

    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

    At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

    For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

    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.

    The anticipated base pay range for this position is $129,500 - $194,000.

    Employees may be eligible to participate in Company employee benefit programs such as health insurance, savings plan, pension plan, disability plan, vacation pay, sick time, holiday pay, and work, personal and family time off in accordance with the terms of the applicable plans. Additional information can be found through the link below.

    For additional general information on company benefits, please go to: https://www.careers.jnj.com/employee-benefits

    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.

    Ready to be part of something great? Don't forget to apply. We want YOU!

Primary Location

United States-Pennsylvania-Spring House-Welsh & McKean Roads

Organization

Janssen Research & Development, LLC (6084)

Job Function

R&D

Requisition ID

2206076219W

DirectEmployers