Director, Medical Writing, Oncology - Titusville

Job summary

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

The Director of Regulatory Medical Writing RegMW is recognized as a leader with extensive medical writing expertise for documents across various therapeutic areas TAs This role is a primary liaison with cross-functional teams driving strategic discussions developing internal medical writers ensuring adherence to best practices regulatory guidelines The Director RegMW has authority oversee projects identify risks implement process improvements while managing internal teams contributing organizational initiatives You Will Be Responsible For Assume overall accountability decision-making within organization or TA ensuring alignment strategic goals Proactively identify potential risks develop strategies mitigate them enhancing project outcomes minimizing obstacles Write provide guidance other writers all types clinical regulatory safety documents taking proactive lead content scientific strategy complete independence Represent MW department decisionmaking authority R&D organization leading discussions senior cross-functional colleagues external partners enhance coordination departments Directly lead set objectives team projects tasks including leading program-level submission indication disease area writing teams independently Mentor support coach staff document planning processes content peer review needed Maintain disseminate knowledge industry company regulatory guidelines relevant company systems Participate industry standards working groups represent MW ensure alignment best practices Accountable setting strategy operational execution portfolio(s) within Medical Writing MW team close consultation accordance Delivery Unit DU Head line R&D priorities TA objectives Recognized expert medical writer any document within across TAs Accountable resource management allocation portfolio(s) Can represent MW DU Head department at highlevel crossfunctional TA meetings significant independent decisionmaking authority Can step absence Major contributor multiple deliverables function TA DU Provides leadership writing teams helping attract retain top talent developing team members ensuring organizational effectiveness transparency communication Creates environment employees feel engaged empowered take pride role responsibilities deliverables Takes additional major responsibility minimal supervision operating expert level accountability highest levels quality Crossfunctional crossTA crossJ&J initiative/collaboration Larger organizational responsibility eg manage subset functional area/TA organization some level independence operate that subset organization Supervises/manages accountable direct reports Sets objectives agrees goals direct reports Provides performance oversight providing feedback development Regularly meets direct reports ensure appropriate development projects assignments issues resolved Ensures direct report adherence established policies procedural documents templates Participates hiring staff onboarding new staff conducting career talent development discussions staff goalsetting endofyear performance reviews compensation planning If applicable frequent engagement staff leading discussions employee development talent management A university college degree scientific discipline required Advanced degree eg Masters PhD MD preferred Minimum years pharmaceuticalscientific experience required Minimum years clinicalmedical writing experience required Minimum people management experience required Experience providing strategic operational leadership medical writing teams all levels responsibility setting vision driving functional excellence mentoring leaders successfully delivering highquality compliant clinical regulatory documentation portfolio Expertise project management process improvement Strong decisionmakingskills strategic thinking agility broad vision Excellent oral written communication skills Attention detail Expert time management self direct reports if applicable Ability delegate responsibility other medical writers Expert ability lead influence example stay focused positive Demonstrate integrity Expert ability motivate develop best class talent pipeline Demonstrated ability collaborate internally develop effective partnerships key business customers Creations positive Credobased work environment staff members Shows openness new ideas fosters organizational learning

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