Associate Director, Safety Analysis Scientist

Johnson & Johnson•Horsham, PA

14d•$137,000 - $235,750

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. Learn more at https://www.jnj.com/innovative-medicine We are searching for the best talent for an Associate Director, Safety Analysis Scientist to be located in Horsham, PA; Raritan, NJ; or Titusville, NJ. Purpose: The Associate Director (AD), Safety Analysis Scientist (SAS) provides scientific expertise and leads the safety assessment of assigned products. 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. The AD, SAS will assist the Medical Safety Officer (MSO) with activities related to the SMT and with contributions to key safety and clinical documents. They will have in-depth product knowledge, will serve as product point of contact, and will provide training to, and oversight of deliverables prepared by, other team members as needed (for complex reports). The AD, SAS will function with a high level of independence, with minimal guidance from the Director, Safety Analysis Scientist (SAS) Therapeutic Area Lead (TAL), be able to link discussions to content, and consistently deliver high quality results with minimal guidance. The AD will quickly build alliances and be able to independently influence other safety partners to shape strong decisions/outcomes.

Requirements

A minimum of a Bachelor’s degree in Biomedical Science or a Healthcare related field is required. An advanced degree is preferred.
8+ years of relevant experience is required.
Medical writing or Pharmacovigilance (PV) experience is required.
Working knowledge of medical concepts and familiarity with safety activities in drug development and post marketing and global safety health authority requirements is required.
Ability to understand and analyze complex medical-scientific data from a broad range of fields is required.
Ability to interpret and present complex data to determine benefit-risk impact is required.
Excellent English verbal and written communication skills is required.
Ability to plan work to meet deadlines and effectively balance multiple priorities is required.

Nice To Haves

Ability to effectively interact with team members, including business partners is preferred.
Ability to work in a matrix environment, proven leadership skills is preferred.
Proficiency in Microsoft applications (e.g., Word, Excel, and PowerPoint) is preferred.
Ability to independently influence, negotiate and communicate with both internal and external customers is preferred.
Clinical experience is preferred.

Responsibilities

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

Benefits

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.
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)).
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