MGR/SR MGR, REGULATORY MEDICAL WRITING (1 of 2 openings)
Category : R&D
Industry : Consumer Goods
Employer : Johnson & Johnson
Janssen Research & Development, L.L.C., a member of Johnson & Johnson's Family of Companies, is recruiting for a MGR/SR, Regulatory Medical Writing in the Spring House Pennsylvania area, Europe, U.K., Switzerland, Canada, and Belgium (1of 2 openings). Remote work options may be considered, on a case-by-case basis and if approved by the Company!
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, hematology, immunology, neuroscience, infectious diseases, cardiovascular, metabolic, mental health, and pain management, and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.
Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees, and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life, and supports their efforts to have a positive impact on their communities.
- Leads in a team environment and matrix.
- Applies and contributes to internal standards, regulatory, and publishing guidelines.
- Master the use of and contributes to the improvement of internal systems, tools, and processes.
- Expected to prepare complex documents within and across therapeutic areas (TAs) (see examples under "principal responsibilities") independently.
- Expected to function as a lead writer on any compound independently.
- Lead discussions in or lead process working groups.
- May lead and actively participate in setting functional tactics/strategies.
- Initiates 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: Manage a team of internal medical writers (direct reports).
- Accountable for compliance aspects of direct reports' work.
- May actively participate in resource management and provide input into hiring decisions.
- Prepares and finalizes all types of clinical documents, taking a proactive or lead role in terms of content and scientific strategy. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency.
- Leads in a team environment. Works with a high level of independence and takes a lead role on assigned projects with respect to timing, scheduling, and tracking.
- Directly leads or sets objectives for other on team projects and tasks, eg, expected to lead process working groups or Communities of Practice.
- Guide or train cross-functional team members on processes, best practices; coach or mentor more junior writers.
- Expected to lead compound/submission/indication/DAS writing teams with minimal supervision.
- Proactively provides recommendations for departmental process improvements.
- If a Lead Writer, principal responsibilities include, but are not limited to:
- Primary point of contact for Clinical/Global Program Team for medical writing activities.
- Responsible for functional planning and metrics database updates for assigned program.
- Responsible for championing RegMW best practices on assigned program.
- Responsible for setting strategy and leading writing group on health authority submissions.
- If a people manager:
- Supervise/manage direct reports. Sets objectives for direct reports with some support from manager.
- Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
- May participate in hiring staff, onboarding new staff, conducting career and talent development discussions for staff, and in goal-setting and end-of-year calibration reviews and performance discussions, and contribute to compensation planning.
- Regularly meets with manager, mentors, and external vendors. Attends departmental meetings.
- Actively participates in Medical Writing 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.
- May lead process working groups.
- Completes all time reporting, training, metrics database, and project tracking (functional planning) updates as required.
- 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 to strengthen coordination between departments.
- May represent medical writing in industry standards working groups.
- Functional Contacts Inside the Company (as collaborator and peer): RegMW leadership team, manager, peer writers. Employees from other departments such as Global Development, Quantitative Sciences, BioResearch Quality & Compliance, TA staff (Clinical), Regulatory Affairs,
- GMS, PMO, Clin Pharm, Human Resources; Finance, Information technologies, Janssen R&D Procurement and External Alliances. May interact with senior external colleagues with coordination between departments.
- Contacts Outside the Company: May oversee day-to-day project-related work of contractors or external service providers as needed. May collaborate with external partner company staff on codeveloped compounds.
- Supervision (direct): Direct reports (if applicable), and others as assigned.
Education and Experience Requirements:
- A university/college degree is required plus at least 10 years in relevant pharmaceutical/scientific experience. An advanced degree (eg, Masters, PhD, MD) is preferred.
- At least 8 years of relevant medical writing experience is required.
- 0-2 years of people management experience if a people manager.
- Experience in project management and process improvement is required.
Decision Making and Problem Solving:
- Recognizes how to best interpret, summarize and present statistical and medical information to ensure quality and accuracy of content in complex document types independently.
- Responsible for establishing document timelines and strategies independently.
- Resolves complex problems independently.
- May assign projects and resolve issues with writing team members.
- Interacts with senior cross-functional colleagues often requiring coordination across multiple functions and groups to resolve issues.
- If applicable as manager of direct reports, lead discussions about direct report goal-setting, performance evaluations and ratings, promotions, salary adjustments, in close interaction with TA head.
Qualities and Characteristics:
- 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.
- Demonstrates learning agility.
- Builds and maintains solid and productive relationships with cross-functional team members.
- Expert project management skills, strong project/process leadership.
- Strong leadership skills (influencing, negotiating, assertiveness, taking initiative, conflict management, change management).
- People management skills with support from manager, as appropriate.
- Solid knowledge and application of regulatory guidance documents such as ICH requirements.
At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.
For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Ready to be part of something great? Don't forget to apply. We want YOU!
United States-Pennsylvania-Spring House-Welsh & McKean Roads
North America-Canada, Europe/Middle East/Africa-Switzerland, Europe/Middle East/Africa-United Kingdom, Europe/Middle East/Africa-Belgium, Europe/Middle East/Africa-United Kingdom-England
Janssen Research & Development, LLC (6084)