Associate Director, Safety Analysis Scientist

Johnson & Johnson Innovative Medicine•Horsham, PA

1d•Hybrid

About The Position

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. As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. 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. The Associate Director (AD) Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. The AD SAS, in partnership with the Medical Safety Officer (MSO), is responsible for the preparation of scientific safety analysis and evaluations, which are required for regulatory compliance and to aid in safety-related decisions for marketed products and products in development. The AD SAS will support product Safety Management Teams (SMTs) and work in close collaboration with other cross-functional safety partners to determine a product’s safety strategy, complete safety analyses and evaluations, proactively review safety data/lead safety data review meetings and interpret safety information to make a recommendation, supporting SMT deliverables as required.

Requirements

Minimum of a Bachelor’s Degree in Healthcare-related or Biomedical Science, with at least 10 years of industry experience or equivalent required
Medical writing or Pharmacovigilance (PV) experience
Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements.
Ability to understand and analyze complex medical-scientific data from a broad range of disciplines.
Ability to interpret and present complex data to determine benefit-risk impact.
Ability to effectively interact with stakeholders, including business partners.
Ability to work in a matrix environment with proven leadership skills.
Ability to plan work to meet deadlines and effectively handle multiple priorities.
Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint).
Ability to independently influence, negotiate and communicate with both internal and external customers.

Nice To Haves

Master’s Degree in Healthcare-related or Biomedical Science, with at least 8 years of industry experience or equivalent is preferred
PhD in Healthcare-related or Biomedical Science, with at least 6 years of industry experience or equivalent is preferred
Clinical experience

Responsibilities

Lead safety evaluations including strategy discussions, collaborating with Therapeutic Area Safety Head (TASH)/MSO and other stakeholders as necessary, data retrieval, data analysis, report writing, and report revision.
Ensure high quality safety evaluations and reports with minimal comments from stakeholders and minimal revisions required.
Provide input and review of key regulatory or clinical documents as appropriate.
Demonstrate leadership in the SMT and support the MSO.
Support SMT activities (e.g., preparing and presenting data, compiling meeting minutes, updating signal tracking information).
Lead proactive safety data reviews, if applicable, and form a safety position across Global Medical Safety (GMS) which can be leveraged for aggregate safety reports.
Provide support for Health Authority interactions regarding safety and risk management, both written and verbal.
Assume responsibility for novel projects, create value and innovate without defined processes.
May seek guidance from Directors (i.e., SAS TAL) for complex projects.
Lead cross-functional training of relevant stakeholders.
Act as product or process Subject Matter Expert (SME) for audits/inspections.
Participate in, or lead, department and/or cross-functional initiatives.
Explore innovative ways of presenting data, preparing reports, and improving efficiencies within the programs they own.
Assist Directors in the creation, review and implementation of controlled documents and other related tools.
Management of unscheduled reports within the Aggregate Report Calendar.
Management activities within smaller Therapeutic Areas, as applicable.
Line-management of contractor positions within the team, as applicable.
Act as backup to TAL as needed (e.g., Director SAS TAL is unavailable).
Oversight of deliverables by other team members (e.g., complex reports), as needed.

Benefits

annual performance bonus in accordance with the terms of the applicable plan
medical insurance
dental insurance
vision insurance
life insurance
short and long-term disability insurance
business accident insurance
group legal insurance
Company’s consolidated retirement plan (pension)
savings plan (401(k))
long-term incentive program
Vacation –120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 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
Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave – 80 hours in a 52-week rolling period
Volunteer Leave – 32 hours per calendar year
Military Spouse Time-Off – 80 hours per calendar year