Manager, Regulatory Medical Writing, Oncology

Description

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.

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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 Manager, 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-068708

Belgium & Netherlands - Requisition Number: R-071158

United Kingdom- Requisition Number: R-071165

Switzerland- Requisition Number: R-071164

Canada- Requisition Number: R-071178

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 write and coordinate basic and complex documents independently within and across therapeutic areas (TAs).
• Leads in a team environment and matrix.
• Able to function independently as a lead writer on any compound. May consult with more senior colleagues on complex situations.
• Leads discussions in or leads process working groups.
• May lead and actively participate in setting functional tactics/strategy.
• Initiates or provides input into TA-level strategy (eg, submission team, global program team, clinical team).
• Able to oversee the work of external contractors.
• If a people manager:
  • Manages a team of internal medical writers (direct reports).
  • Accountable for the quality of deliverables and for compliance of direct reports.
  • Participates in resource management and hiring decisions.

You will be responsible for:

• 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.
  • Sets objectives and agrees on goals for direct reports. Provides performance oversight, including providing 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.

Qualifications/Requirements:

Education: Minimum of a university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.

Experience:

• 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.

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