Brand Safety Leader Job

BRAND SAFETY LEADER needed for a CONTRACT opportunity with Yoh's client located in EAST HANOVER, NEW JERSEY.

THE BIG PICTURE - TOP SKILLS YOU SHOULD POSSESS:

- Risk Management
- Safety Management
- New Product Development

WHAT YOU'LL BE DOING:

- Development of processes and identify and qualify new business opportunities.
- Work closely with market research group to discover new consumer/patient insights.
- As initiatives advance toward market launch, this role will also support the development of the winning consumer & ECP big idea, and lead concept, claims, key benefit and RTB visuals, as well as any relevant sights & sounds cues.
- Must be proficient in market landscape assessment, analysing diverse market segments and providing recommendations on new market opportunities.
- This position also supports BD&L in the scouting and due diligence processes with market assessment and financial calculations.
- Responsible for safety issue management from end of Phase I (POC) through Life Cycle Management.
- Accountable for overall signal detection, monitoring, evaluation, interpretation and appropriate management of safety information, based on information from all relevant line functions, post marketing data, and other sources.
- Accountable for developing and updating, at milestones, the safety profiling and risk management plan from end of Phase I (POC) through Life Cycle Management, as relevant. Accountable to ensure adequate risk management plans are in place.
- Serves as safety representative as core member of Global Program Teams.
- Manages Drug Safety Monitoring Board activities for assigned projects/products, as required.
- Accountable for integrated safety input into all safety relevant parts of regulatory and company documents (ie IB, CDS, SCS, RMP, SPP, CO, PIP, GDPS, CDP, etc.) required during active development, submission phase and during marketing phase.
- Review of medical safety input into study protocols (including MRC and OPCE) MAP, RAP and ICF.
- Review/approve product-specific safety deliverables: IN letter, PGD, data searches, literature review, expert statements.
- Coordinates involvement of external experts (eg authors of "white papers," members of trial-specific data safety monitoring boards, ad-hoc support for HA meetings, etc.
- Accountable for presentations on project/product safety issues to internal Novartis Boards, or expert panels and other meetings.
- Collaborates productively and manages in a cross-functional Matrix team environment (eg, SMT).
- Assist in training of new hires (eg new BSLs) and mentor/coach direct reports (PVL/PVE) as required.
- Provides support as needed for licensing activities, regulatory authority inspections and for project/product recall activities.

WHAT YOU NEED TO BRING TO THE TABLE:

- MD required.
- Three years medical experience postdoctoral.
- At least five years in industry or health authority or CRO (of which two years in a global position), including a minimum of three years in drug safety.
- Experience in preparing clinical safety assessments, risk/benefit evaluations and regulatory reports.
- Experience in leading cross-functional, multi-cultural teams.
- Experience in preparing RMPs, PSURs, submission dossiers (SCS).
- Global experience as well as innovation.
- New product development, and/or new product launch experience.

WHAT ARE YOU WAITING FOR? APPLY NOW!

RECRUITER: Corrin Pyle

Yoh, a DayJ2W: SCIENTIFIC; MONJOB

TAX TERM: CON_W2J2WMIDATL

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SFSF: LS