Manager, Regulatory Medical Writing, Oncology

Johnson & Johnson•Titusville, PA

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. 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. 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. The purpose of this role is to write and coordinate basic and complex documents independently within and across therapeutic areas (TAs). The Manager leads in a team environment and matrix, and is able to function independently as a lead writer on any compound. They may consult with more senior colleagues on complex situations. The role leads discussions in or leads process working groups, and may lead and actively participate in setting functional tactics/strategy. They may also initiate or provide input into TA-level strategy (e.g., submission team, global program team, clinical team) and oversee the work of external contractors. If a people manager, this role manages a team of internal medical writers (direct reports), is accountable for the quality of deliverables and for compliance of direct reports, and participates in resource management and hiring decisions.

Requirements

Minimum of a university/college degree in a scientific discipline is required.
At least 8 years of relevant pharmaceutical/scientific experience is required.
At least 6 years of relevant clinical/regulatory medical writing experience is required.
0-2 years of people management experience if a people manager.
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 majority of problems independently.
May interact with senior cross-functional colleagues often requiring coordination across multiple functions and groups to resolve issues.
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.
Strong leadership skills, both in project and process management as well as in time management (influencing, negotiating, assertiveness, taking initiative).
Demonstrates learning agility.
Builds and maintains solid and productive relationships with cross-functional team members.
Solid knowledge and application of regulatory guidance documents such as ICH requirements.
If a people manager, lead discussions about direct report goal-setting, performance evaluations and ratings, promotions, and salary adjustments, in close interaction with TA head.

Nice To Haves

An advanced degree (eg, Masters, PhD, MD) is preferred.
Business Writing
Clinical Research and Regulations
Clinical Trials Operations
Coaching
Collaborating
Copy Editing
Data Synthesis
Industry Analysis
Medical Affairs
Medical Communications
Process Improvements
Proofreading
Quality Validation
Standard Operating Procedure (SOP)
Tactical Planning
Technical Credibility

Responsibilities

Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
Leads or sets objectives for others on team projects and tasks, eg, leading process working groups or Communities of Practice.
Guides or trains cross-functional team members on processes, best practices; coaches or mentors more junior writers.
Able to function as a lead writer on any compound (or submissions, indications, or disease areas): is primary point of contact for medical writing activities for the cross-functional team (eg, clinical), with support as needed from more senior colleagues on complex situations with cross-functional teams.
Leads cross-functional (eg, with clinical team) document planning and review meetings.
Interacts with cross-functional colleagues on document content and champions MW processes and best practices.
Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
Proactively provides recommendations for departmental process improvements.
Completes all time reporting, training, and metrics database updates as required in relevant company systems.
Coaches or mentors more junior staff on document planning, processes, content, and provide peer review as needed.
May interact with senior cross-functional colleagues to strengthen coordination between departments.
May represent medical writing in industry standards working groups.
If a people manager: Supervises/manages and is accountable for direct reports.
If a people manager: Sets objectives and agrees on goals for direct reports.
If a people manager: Provides performance oversight, including providing feedback on performance and development.
If a people manager: Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
If a people manager: Ensures direct report’s adherence to established policies, procedural documents, and templates.
If a people manager: 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

Annual performance bonus
Medical insurance
Dental insurance
Vision insurance
Life insurance
Short and long-term disability insurance
Business accident insurance
Group legal insurance
Consolidated retirement plan (pension)
Savings plan (401(k))
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 period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year