Johnson & Johnson
Associate Director, Regulatory Medical Writing - Oncology
Johnson & Johnson, Spring House, Pennsylvania, United States
This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly.
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 https://www.jnj.com
Job Function: Medical Affairs Group
Job Sub
Function: Medical Writing
Job Category: Professional
All 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
Job Description: 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 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-010375 Canada
- Requisition Number: R-011450 Netherlands, Germany, Spain, France - Requisition Number: R-011453 Remember, whether you apply to one or all 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 all 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 lead 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 complex documents within 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 lead process working
groups.
Able to oversee 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 lead compound/submission/indication/disease area writing teams
independently.
Directly leads or sets objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead 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 develop and present best practices or innovations to internal or external
audiences.
May lead 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 all 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 lead 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 lead, is the primary point 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 oversight, 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 complex document types independently.
Resolves complex 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 related to development and implementation of new service
offerings/deliverables.
Ability to serve as the liaison between team members and senior leadership within 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 lead by example, stay focused and positive, and act with
integrity.
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 base pay range for this position is 137000 to 235750. The Company maintains highly competitive, performance-based compensation programs. Under current 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 achieve 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 State of Washington - 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 found 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 outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, 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. Johnson & Johnson 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,
external applicants please contact us via
https://www.jnj.com/contact-us/careers
. internal employees contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is : The anticipated base pay range for this position is 137000 to 235750. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 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
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours
Additional information can be found through the link below.
https://www.careers.jnj.com/employee-benefits]]>
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 https://www.jnj.com
Job Function: Medical Affairs Group
Job Sub
Function: Medical Writing
Job Category: Professional
All 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
Job Description: 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 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-010375 Canada
- Requisition Number: R-011450 Netherlands, Germany, Spain, France - Requisition Number: R-011453 Remember, whether you apply to one or all 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 all 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 lead 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 complex documents within 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 lead process working
groups.
Able to oversee 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 lead compound/submission/indication/disease area writing teams
independently.
Directly leads or sets objectives for others on team projects and tasks, eg, able to lead Medical Writing (MW) process working groups or Communities of Practice.
Writes or coordinates all types of clinical and regulatory documents, taking a proactive or lead 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 develop and present best practices or innovations to internal or external
audiences.
May lead 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 all 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 lead 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 lead, is the primary point 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 oversight, 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 complex document types independently.
Resolves complex 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 related to development and implementation of new service
offerings/deliverables.
Ability to serve as the liaison between team members and senior leadership within 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 lead by example, stay focused and positive, and act with
integrity.
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 base pay range for this position is 137000 to 235750. The Company maintains highly competitive, performance-based compensation programs. Under current 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 achieve 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 State of Washington - 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 found 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 outside the United States will be eligible for compensation and benefits in accordance with their local market. Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, 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. Johnson & Johnson 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,
external applicants please contact us via
https://www.jnj.com/contact-us/careers
. internal employees contact AskGS to be directed to your accommodation resource.
The anticipated base pay range for this position is : The anticipated base pay range for this position is 137000 to 235750. Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees and/or eligible dependents are 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.
Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, Employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 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
Condolence Leave - 30 days for an immediate family member: 5 days for an extended family member
Caregiver Leave - 10 days
Volunteer Leave - 4 days
Military Spouse Time-Off - 80 hours
Additional information can be found through the link below.
https://www.careers.jnj.com/employee-benefits]]>