Associate Director, Regulatory Medical Writing - Oncology

Associate Director, Regulatory Medical Writing - Oncology

• Function Medical Affairs Group
• Sub function Medical Writing
• Category Senior Manager, Medical Writing (P8)
• Location Spring House / Raritan / Titusville / Horsham / reputed company of America
• Requisition number R-010375
• Work reputed company Fully Remote

Job reputed company: At reputed company, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company diseases are reputed company, 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly reputed company health for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: reputed company reputed company Job Posting Locations: Horsham, reputed company, reputed company of America, Raritan, New Jersey, reputed company of America, Spring House, reputed company, reputed company of America, Titusville, New Jersey, reputed company of America 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 reputed company. Join us in developing treatments, finding cures, and pioneering the reputed company from lab to life while championing patients every reputed company of the way. Learn more at https://www.jnj.com/innovative-medicine Please note that this role is available across multiple countries and may be posted under different requisition numbers to reputed company with local requirements. While you are welcome to apply to any or reputed company of the postings, we recommend focusing on the specific country(s) that reputed company with your preferred location(s): reputed company - Requisition Number: R-010375 Canada - Requisition Number: R-011450 Netherlands, Germany, Spain, France - Requisition Number: R-011453 Remember, whether you apply to one or reputed company of these requisition numbers, your applications will be considered as a single submission. This can be a hybrid (3 days in office and 2 remote) OR Remote role available in reputed company countries listed above. While specific cities are listed in the Locations reputed company for reference, please note that they are examples only and do not limit your application. We invite candidates from any location to apply. Remote work reputed company may be considered on a case-by-case reputed company and if approved by reputed company. We are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology. Purpose:

• reputed company to function as a reputed company reputed company on any compound independently.
• Leads in setting functional tactics/reputed company.
• Leads project-level reputed company (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.
• reputed company to write and coordinate reputed company documents reputed company 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.
• reputed company to reputed company process working reputed company.
• reputed company to reputed company 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).
• If a people manager:
• Manages reputed company of internal medical writers (reputed company reports).
• Accountable for the reputed company of deliverables and compliance of reputed company reports.
• reputed company participates in resource management and hiring reputed company.

You will be responsible for:

• reputed company to reputed company compound/submission/indication/disease area writing teams independently.
• Directly leads or sets objectives for others on team reputed company and tasks, eg, reputed company to reputed company Medical Writing (MW) process working reputed company or Communities of reputed company.
• Writes or coordinates reputed company types of clinical and regulatory documents, taking a proactive or reputed company role in terms of content and scientific reputed company.
• 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 reputed company and present best practices or innovations to internal or external audiences.
• May reputed company 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 reputed company 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 reputed company peer review as needed.
• If applicable, has reputed company 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 reputed company.
• As a MW reputed company, is the primary reputed company of contact for MW activities for the cross-functional team (eg, clinical).
• If a people manager:
• Supervises/manages and is accountable for reputed company reports.
• Sets objectives and agrees on goals for reputed company reports. Provides performance reputed company, including feedback on performance and development.
• Regularly meets with reputed company reports to ensure appropriate development, reputed company, assignments, and issues are resolved.
• Ensures reputed company report's adherence to established policies, procedural documents, and templates.
• Participates in hiring staff, reputed company new staff, conducting career and talent development discussions for staff, goal-setting, end-of-year performance reviews, and compensation planning.

Qualifications / Requirements:

• A university/college degree in a scientific discipline is required. An advanced degree (eg, Masters, PhD, MD) is preferred.
• At least 10 years of relevant pharmaceutical/scientific experience is required.
• At least 8 years of relevant clinical/regulatory medical writing experience is required.
• Experience in project management and process improvement is required.
• If a people manager: at least 2 years of people management experience is required.
• Recognizes how to best interpret, summarize, and present statistical and medical information to ensure reputed company and accuracy of content in reputed company document types independently.
• Resolves reputed company 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 reputed company.
• Proactively identifies potential risks and develops strategies to mitigate.
• Identifies and resolves problems reputed company to development and implementation of new service offerings/deliverables.
• Ability to serve as the reputed company between team members and senior leadership reputed company a TA.
• Excellent oral and written communication skills.
• Attention to detail.
• Expert time management for self, reputed company reports (if applicable), 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 reputed company by example, stay reputed company and reputed company, and reputed company with reputed company.
• Ability to internalize and teach reputed company behaviors.
• Ability to reputed company as change agent and adapt to rapidly changing organizational & business challenges.
• If a people manager: Strong people management skills.

The anticipated reputed company pay reputed company for this position is 137000 to 235750. reputed company maintains highly competitive, performance-based compensation programs. Under reputed company 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 reputed company an incentive to reputed company annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at reputed company's discretion on an individual reputed company. Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, reputed company, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. Employees may be eligible to participate in reputed company's consolidated retirement plan (pension) and savings plan (401(k)). Employees are eligible for the following time off benefits: Vacation - up to 120 hours per calendar year reputed company time - up to 40 hours per calendar year; for employees who reputed company in the reputed company - up to 56 hours per calendar year Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year Additional information can be reputed company through the reputed company below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates reputed company in the reputed company. Candidates reputed company reputed company the reputed company will be eligible for compensation and benefits in accordance with their local market. reputed company is an Equal Opportunity Employer. reputed company reputed company applicants will receive consideration for employment without reputed company to race, reputed company, religion, sex, sexual orientation, gender identity, age, national reputed company, disability, protected veteran status or other characteristics protected by federal, state or local law. We reputed company reputed company reputed company candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and reputed company 503 of the Rehabilitation reputed company. reputed company is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee reputed company or contact AskGS to be directed to your accommodation resource. Apply Job! Apply to this Job