Scientific Affairs Manager

6 months ago

Markham, Canada Johnson & Johnson Full time

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.

  • Scientific Service Representative

    4 weeks ago

    Markham, Ontario, Canada Thermo Fisher Scientific Full time

    Job Summary:We are seeking a highly skilled Scientific Service Representative to join our team at Thermo Fisher Scientific. As a key member of our customer service team, you will be responsible for delivering exceptional service to our internal and external clients, focusing on service repairs, parts management, and scientific instrumentation.Key...

  • Scientific Customer Service Representative

    1 month ago

    Markham, Ontario, Canada Thermo Fisher Scientific Full time

    Key Responsibilities:Deliver exceptional customer service to internal and external clients, focusing on service repairs, parts management, and scientific instrumentation.Effectively manage multiple tasks and systems simultaneously while interacting with customers via phone and email, ensuring seamless service delivery.For Ontario-based candidates:...

  • Medical Affairs Director

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Therapeutic Area Head, Oncology MA Job DescriptionAstellas Pharma Canada is seeking a strategic Medical Affairs Director to lead the Oncology Therapeutic Area. Reporting to the Head of Medical Affairs - Canada, this role will oversee all Medical Affairs activities and deliverables for the assigned Therapeutic Areas.Key Responsibilities:Develop and maintain...

  • Medical Affairs Director, Oncology

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Astellas Pharma Inc. is seeking a highly skilled Medical Affairs Director to lead our Oncology team in Canada.This is an exciting opportunity to join a dynamic team and contribute to the development of innovative medical solutions.About the Role:The Medical Affairs Director will be responsible for providing strategic leadership and direction to the Oncology...

  • Medical Affairs Director, Oncology

    2 weeks ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Astellas Pharma Inc. is currently seeking a seasoned Medical Affairs expert to lead our Oncology team in Canada.As the Medical Affairs Director, Oncology, you will provide strategic leadership and direction to our Medical Affairs activities in the assigned therapeutic areas, ensuring all deliverables are based on scientific validity, clinical importance,...

  • Senior Medical Affairs Director, Oncology Therapeutic Area

    1 week ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job OverviewAstellas Pharma Inc. is seeking a highly skilled Senior Medical Affairs Director to lead our Oncology Therapeutic Area team.This role will be based at our head office in Markham, Ontario, and will report to the Head of Medical Affairs Canada.Estimated Salary Range:$140,000 - $180,000 per annum, depending on experience.About the RoleThe successful...

  • Therapeutic Area Leader, Oncology Medical Affairs

    1 month ago

    Markham, Ontario, Canada Astellas Full time

    Job SummaryAstellas Pharma Canada is seeking a highly skilled Therapeutic Area Lead to oversee Medical Affairs activities for the Oncology therapeutic area. The successful candidate will provide strategic leadership and direction to ensure all MA activities are aligned with local business needs and advance the medical/scientific understanding of Astellas...

  • Contract Regulatory Affairs Manager

    6 months ago

    Markham, Canada Astellas Full time

    Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas! Astellas Pharma Canada, Inc. is committed to providing patients,...

  • Business Operations Coordinator

    2 weeks ago

    Markham, Ontario, Canada Trust Plus Overseas Affairs Consulting Inc. Full time

    At Trust Plus Overseas Affairs Consulting Inc., we are seeking a highly organized and detail-oriented Business Operations Coordinator to join our team.Job SummaryThe Business Operations Coordinator will be responsible for coordinating the flow of information within the team, ensuring seamless communication and productivity.This role requires a proactive...

  • Therapeutic Area Head, Oncology MA

    1 month ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job DescriptionAstellas Pharma Canada is currently seeking a highly skilled and experienced professional to fill the role of Therapeutic Area Head, Oncology MA. This position is part of our Medical Affairs Division and will report to the Head MA - Canada.This is a head office position located onsite in our Markham, Ontario.Job SummaryThe Therapeutic Area...

  • Scientific Systems Administrator

    1 week ago

    Markham, Ontario, Canada Astellas Full time

    Astellas, a global pharmaceutical company headquartered in Japan, is seeking a skilled Scientific Systems Administrator to join our team. We are committed to becoming a cutting-edge, value-driven life science innovator.As the Subject Matter Expert for laboratory systems, you will be responsible for system administration, maintenance, and enhancements. Your...

  • Therapeutic Area Head, Oncology MA

    4 months ago

    Markham, Canada Astellas Pharma Inc. Full time

    Job Description Astellas Pharma Canada is currently searching for Head, TA Oncology MA – Canada in our Medical Affairs Division reporting to the Head MA - Canada. This is a head office position located onsite in our Markham, Ontario. Description:Provides strategic Medical Affairs (MA) Leadership in overseeing all MA activities / deliverables for the...

  • Expert in Scientific IT Landscape Solutions

    3 weeks ago

    Markham, Ontario, Canada Astellas Full time

    Astellas: A Leader in Pharmaceutical InnovationWe are a global pharmaceutical company that strives to create a brighter future for patients around the world. Our team of over 14,000 talented individuals manages operations in approximately 70 countries, making us one of the top 30 global biopharma companies based on global revenues.As a Global QC Labs...

  • Therapeutic Area Head, Oncology MA

    4 months ago

    Markham, Canada Astellas Full time

    Astellas Pharma Canada is currently searching for Head, TA Oncology MA – Canada in our Medical Affairs Division reporting to the Head MA - Canada.  This is a head office position located onsite in our Markham, Ontario.   Description:Provides strategic Medical Affairs (MA) Leadership in overseeing all MA activities / deliverables for the assigned...

  • Scientific Laboratory Manager for Finished Products Development

    1 week ago

    Markham, Ontario, Canada SGS Full time

    At SGS, we are seeking a highly skilled Scientific Laboratory Manager to lead our Finished Products team. This is an exciting opportunity to join our organization and contribute to the success of our clients.About the RoleWe are looking for a seasoned professional with experience in managing laboratory teams and driving business growth. As a Scientific...

  • Customer Service Representative I

    3 months ago

    Markham, Canada Thermo Fisher Scientific Full time

    : Deliver outstanding customer service for both internal and external clients, focusing on service repairs, parts management, and scientific instrumentation. Effectively manage multiple tasks and systems simultaneously while interacting with customers via phone and email, ensuring seamless service delivery. For Ontario-based candidates: Participate in...

  • Medical Manager Specialties

    6 months ago

    Markham, Canada Astellas Pharma Inc. Full time

    Job Description Astellas Canada - Medical Manager, SpecialtiesAt Astellas, we strive to become a cutting-edge, value-driven life science innovator. This means working at the forefront of healthcare change to turn innovative science into VALUE for patients. What sets us apart is our focus on patients, our pioneering innovation, our collaborative culture,...

  • Medical Manager, Women's Health Expert

    1 week ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    Job Opportunity at Astellas Pharma Inc.We are seeking a highly skilled Medical Manager to join our team in Markham, Ontario. This is an exciting opportunity to work with a global pharmaceutical company that is committed to delivering innovative treatments to patients around the world.About the RoleThe successful candidate will be responsible for implementing...

  • Medical Manager Specialties

    1 month ago

    Markham, Ontario, Canada Astellas Pharma Inc. Full time

    About Astellas Pharma Inc.Astellas Pharma Inc. is a global pharmaceutical company headquartered in Japan, with a team of over 14,000 managing operations in approximately 70 countries around the world. We are in the Top 30 global biopharma company based on global revenues and are predicted to be one of the Top 10 Cancer Drug Makers of 2024 by Fierce Pharma.We...

  • Regulatory Affairs Specialist-12 Month Contract

    2 months ago

    Markham, Canada Kenvue Full time

    Description Kenvue is currently recruiting for: **Regulatory Affairs Specialist-12 month contract** This position reports to the Associate Director Regulatory Affairs and is based in Markham, Canada **Who we are** At Kenvue, we realize the extraordinary power of everyday care. Built on over a century of heritage and rooted in science, we’re the house...