Scientific Affairs Manager
4 months ago
Johnson and Johnson Medical Device Companies is recruiting for a **Scientific Affairs Manager **located in Markham, Ontario.
The Johnson & Johnson Medical Devices Companies have been working to make surgery better for more than a century. With substantial breadth and depth in surgical technologies, orthopedic and interventional solutions, we aspire to improve and enhance medical care for people worldwide. Together, we are working to shape the future of health through differentiated products and services.
The Scientific Affairs Manager is responsible for the operational elements of the clinical research activities including, p-Value evidence programs, local and global company-sponsored clinical trials, and Investigator-Initiated Studies (IIS) across the CSS, DePuy Synthes and Ethicon franchises. This individual will also be responsible for administration of the content approval process and triaging medical information requests to the appropriate business partners.
**Essential duties and responsibilities**:
(1) Clinical Research Operations
a. Responsible for end-to-end clinical operations including planning, adherence to procedures, budget, resources and expected deliverables
b. Works closely with Scientific Affairs, Regulatory, Finance, Compliance, Quality and Legal as needed to manage issues that may impact the budget, timeline or quality of expected deliverables and contributes to a corrective action plan if necessary
c. Track study progress
d. Manage payments to sites/Investigators
e. Develop training materials, track essential documents, update electronic systems
f. Manage interactions with global franchise clinical colleagues
g. Develop clinical trial dashboards and report back to cross-functional partners
h. Identify (and mitigate) risks in study planning and execution
i. Publication tracking as required
j. Work closely Medical Directors for trial coordination and other medical affairs activities
(2) Copy Approval / Promotional Integrity
a. Copy Review administrator: triage copy review requests using defined criteria and clinical judgement where appropriate
b. Input into business processes for content development strategy
(3) Medical Information
a. Monitor Medical Information Inbox and triage requests as appropriate
(4) Scientific Affairs
a. Keep abreast of current clinical and scientific trends - with impacts on access and adoption customers
b. Bring scientific, technical, and operational expertise to the franchise business plan and life cycle
c. Contributes to the development and ongoing update to procedures, standards, and training (SOP, job aids, guidebook etc.).
d. Ensure compliance with product safety information reporting requirements (reporting adverse effects/product quality complaints within the stated time frames) as defined by J&J standard policies and procedures (Standard Operating Procedures, SOP)
e. Ensure the full understanding of appropriate management of and compliance with HCC requirements and legal obligations (fair market value, transfer value rules, rules governing marketing materials) for Research Related activities (RRA)
f. Ensure inspection-readiness related to the RRA
g. Develops an open and effective communication network with S&PA, Regulatory, HEMA, global and franchise teams to share best practices and optimize processes
h. Produces metric reports for the Medical Directors, HEMA, Regulatory, Franchise Leaders and Leadership Team
**Special Qualifications**
- Excellent interpersonal skills and project management experience in a complex and changing environment
- Skills needed to communicate and influence in a cross-functional environment
- Ability to move from a vision to handling small details, ability to keep to deadlines and follow processes
- Good understanding of the management mechanisms for studies and clinical trials and the rules for publication
- A knowledge of medical technologies covered by JJMT would be an asset
**Qualifications**:
**Requirements**:
- Postgraduate sciences degree (science, medicine, pharmacy)
- Minimum of five years’ experience in science field, medical technology or pharmaceutical industry (medical affairs, regulatory affairs, clinical trials etc.) or in a healthcare environment (hospital, clinical studies, CRO etc.)
**_Preferred: _**
- Two-to-three-years of experience in project management
- Experience in market access, epidemiology, statistics or clinical trials
Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.
Eligible for benefits to include medical, dental, vision and time off as well as any others as provided for in the applicable Collective Bargaining Agreement.
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