Associate Director, Regulatory Medical Writing - Oncology

100% remote Flexible hours Hiring now

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

Job Description: At reputed company, we reputed company health is everything. Our strength in healthcare innovation empowers us to build a world where reputed company 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 reputed company of healthcare solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.com Job Function: Medical Affairs Group Job Sub Function: Medical Writing Job Category: Professional reputed company Job Posting Locations: Horsham, Pennsylvania, United States of America, Raritan, New Jersey, United States of America, Spring House, Pennsylvania, United States of America, Titusville, New Jersey, United States 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 path 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 align with your preferred location(s): United States - 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 section 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 options may be considered on a case-by-case basis and if approved by the Company. We are searching for the best talent for Associate Director, Regulatory Medical Writing - Oncology. Purpose:

Able to function as a reputed company 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 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.
Able to reputed company process working groups.
Able 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 a team of internal medical writers (direct reports).
Accountable for the quality of deliverables and compliance of direct reports.
Actively participates in resource management and hiring decisions.

You will be responsible for:

Able to reputed company compound/submission/indication/disease area writing teams independently.
Directly leads or sets objectives for others on team projects and tasks, eg, able to reputed company Medical Writing (MW) process working groups or Communities of Practice.
Writes or coordinates reputed company types of clinical and regulatory documents, taking a proactive or reputed company 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 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 provide 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 groups.
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 direct reports.
Sets objectives and agrees on goals for direct reports. Provides performance reputed company, 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.

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 quality 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 groups.
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 liaison between team members and senior leadership reputed company a TA.
Excellent oral and written communication skills.
Attention to detail.
Expert time management for self, direct 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 focused and positive, and act with reputed company.
Ability to internalize and teach CREDO behaviors.
Ability to act as change agent and adapt to rapidly changing organizational & business challenges.
If a people manager: Strong people management skills.

The anticipated reputed company pay range for this position is 137000 to 235750. The 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 provide 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 the Company's discretion on an individual basis. Employees and/or eligible dependents may be 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. Employees may be eligible to participate in the 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 Sick time - up to 40 hours per calendar year; for employees who reside 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 link below. http://www.careers.jnj.com/employee-benefits The compensation and benefits information set forth in this posting applies to candidates hired in the United States. Candidates hired reputed company the United States will be eligible for compensation and benefits in accordance with their local market. reputed company is an Equal Opportunity Employer. reputed company qualified applicants will receive consideration for employment without regard to race, color, 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 actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. 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 Health Support Center or contact AskGS to be directed to your accommodation resource. Apply tot his job Apply To this Job

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