Associate Director, Regulatory Medical Writing, Oncology

Johnson & Johnson•Titusville, NJ

1d•Remote

About The Position

At 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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. About Innovative Medicine Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine About Oncology Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for Associate Director, Regulatory Medical Writing, Oncology. Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s): United States - Requisition Number: R-061111 United Kingdom - Requisition Number: R-062446 Switzerland - Requisition Number: R-062450 Netherlands & Belgium - Requisition Number: R-062452 Canada- Requisition Number: R-062453 Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission. Remote work options may be considered on a case-by-case basis and if approved by the Company. Purpose: Able to function as a lead writer on any compound independently. Leads in setting functional tactics/strategy. Leads project-level strategy (eg, submission team, global program team, clinical team). May represent therapeutic area (TA) head at high-level and cross-functional TA meetings and has some independent decision-making authority. Able to write and coordinate complex documents within and across TAs independently. Contributes to and champions internal standards, regulatory, and publishing guidelines. Contributes to and champions the improvement of internal systems, tools, and processes. Able to lead process working groups. Able to oversee the work of external contractors. May have additional major responsibility with supervision: Cross-functional, cross-TA, or cross-J&J initiative/collaboration. Larger organizational responsibility (eg, manage a subset of TA). Manages a team of internal medical writers (direct reports). Accountable for the quality of deliverables and compliance of direct reports.

Requirements

Minimum of a Bachelor's Degree is required.
An advanced degree (eg, Masters, PhD, MD) is preferred.
Minimum of 10 years of relevant pharmaceutical/scientific experience is required.
Minimum of 8 years of relevant clinical/regulatory medical writing experience is required.
Experience in project management and process improvement is required.
A minimum of 2 years of people management experience is required.
Recognizes how to best interpret, summarize, and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
Resolves complex problems independently.
Advanced knowledge and application of regulatory guidance documents such as ICH requirements
Interacts with senior cross-functional colleagues and external partners, often requiring coordination across multiple functions and groups.
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 TA.
Excellent oral and written communication skills.
Attention to detail.
Expert time management for self, direct reports, and teams.
Ability to build and maintain solid and productive relationships with cross-functional team members.
Expert project management skills, expert project/process leadership.
Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
Ability to delegate responsibility to junior writers.
Ability to lead by example, stay focused and positive, and act with integrity.
Ability to internalize and teach CREDO behaviors.
Ability to act as change agent and adapt to rapidly changing organizational & business challenges.
Strong people management skills.

Nice To Haves

Analytics Insights
Business Writing
Clinical Research and Regulations
Clinical Trials Operations
Copy Editing
Cross-Functional Collaboration
Developing Others
Inclusive Leadership
Industry Analysis
Leadership
Medical Affairs
Medical Communications
Performance Measurement
Quality Validation
Standard Operating Procedure (SOP)
Succession Planning
Tactical Planning
Team Management

Responsibilities

Able to lead compound/submission/indication/disease area writing teams independently.
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.
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; coaches or mentors more junior writers.
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, submission team meetings, 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.
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 MW in industry standards working groups.
As a MW lead, is the primary point of contact for MW activities for the cross-functional team (eg, clinical).
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 staff, onboarding new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.

Benefits

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.
Subject to the terms of their respective plans, employees and/or eligible dependents are 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.
Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company’s long-term incentive program.
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
Holiday pay, including Floating Holidays –13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period10 days
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year