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 (e.g., submission team, global program team, clinical team).
* Able to oversee the work of external contractors.
* People manager responsibilities (if applicable):
o Manages a team of internal medical writers (direct reports).
o Accountable for the quality of deliverables and for compliance of direct reports.
o Participates in resource management and hiring decisions.
You Will Be Responsible For
* Write or coordinate all types of clinical and regulatory documents, taking a proactive or lead role in terms of content and scientific strategy.
* Lead or set objectives for others on team projects and tasks, e.g., leading process working groups or Communities of Practice.
* Guide or train cross‑functional team members on processes, best practices; coach or mentor more junior writers.
* Act as the 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.
* Lead cross‑functional document planning and review meetings; interact with cross‑functional colleagues on document content and champion MW processes and best practices.
* Establish document timelines and strategies in accordance with internal processes, with mentorship from functional management and clinical team as needed.
* Proactively provide recommendations for departmental process improvements.
* Complete 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.
* People manager responsibilities (if applicable):
o Supervises/manages and is accountable for direct reports.
o Sets objectives and agrees on goals for direct reports; provides performance oversight, including feedback on performance and development.
o Regularly meets with direct reports to ensure appropriate development, projects, assignments, and issues are resolved.
o Ensures direct report’s adherence to established policies, procedural documents, and templates.
o 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
* Minimum of a university/college degree in a scientific discipline is required. An advanced degree (e.g., Masters, PhD, MD) is preferred.
* 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, leads discussions about direct report goal‑setting, performance evaluations and ratings, promotions, and salary adjustments, in close interaction with TA head.
Compensation
The expected pay range for this position is $117,000 to $201,250.
Benefits
* Eligible for company‑sponsored benefit programs: medical, dental, vision, life insurance, short and long‑term disability, business accident insurance, and group legal insurance.
* Eligible for the company’s consolidated retirement plan (pension) and savings plan (401(k)).
* Eligible to participate in the company’s long‑term incentive program.
* Time‑off benefits:
o Vacation – 120 hours per calendar year
o Sick time – 40 hours per calendar year (48 hours for Colorado residents, 56 hours for Washington residents)
o Holiday pay, including floating holidays – 13 days per calendar year
o Work, personal and family time – up to 40 hours per calendar year
o Parental leave – 480 hours within one year of the birth/adoption/foster care of a child
o Bereavement leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year
o Caregiver leave – 80 hours in a 52‑week rolling period
o Volunteer leave – 32 hours per calendar year
o Military spouse time‑off – 80 hours per calendar year
* Employee‑benefits information: https://www.careers.jnj.com/employee-benefits
Equal Opportunity Employer & Accessibility Statement
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, please contact us via https://www.jnj.com/contact-us/careers or contact AskGS to be directed to your accommodation resource.
Recruitment Information
The posting is anticipated to close on May 1, 2026, though this date may be extended. Candidates hired outside the United States will receive compensation and benefits in accordance with their local market.
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