Manager, Regulatory Medical Writing, Oncology
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, providing an inclusive work environment where diversity and dignity are respected. Our Innovative Medicine expertise is informed and inspired by patients, fueling science-based advancements. The Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures, leading where medicine is going. The Manager, Regulatory Medical Writing, Oncology is responsible for writing and coordinating basic and complex documents independently within and across therapeutic areas. This role involves leading in a team environment and matrix, functioning independently as a lead writer on any compound, and potentially consulting with more senior colleagues on complex situations. The manager may lead discussions in or lead process working groups, and actively participate in setting functional tactics/strategy, as well as provide input into TA-level strategy. The position also involves overseeing the work of external contractors. If a people manager, responsibilities include managing a team of internal medical writers, being accountable for the quality of deliverables and compliance, and participating 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 consult with senior colleagues on higher complexity situations.
- 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 (e.g., 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, e.g., 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.
- Functions 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 (e.g., clinical), with support as needed from more senior colleagues on complex situations with cross-functional teams.
- Leads cross-functional (e.g., 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
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Manager
