Senior Manager, Regulatory Management

2 weeks ago

Toronto ON, Canada Biogen Full time

Reporting to the Medical Director, the Sr. Medical Manager, Medical Affairs is responsible for leading medical strategy and activities for Neuropsychiatry, other therapeutic areas may be assigned as needed.

Co‐create medical strategy in assigned therapeutic area(s), with focus on field strategy, and implement medical tactical plans in alignment with cross functional partners (e.g. Sales and Marketing Managers) and Medical Director

Accountable for overall KME engagement planning in assigned therapeutic area(s) and field engagement metrics (qualitative, quantitative); monitoring and reporting; sharing medical insights above country (regional or global level)

Assist in overseeing the MSL Team in cultivating current and future Key Medical Experts (KMEs) in academic and clinical medicine at the local, regional, and national levels in therapeutic area

Accountable for congress strategy at scientific meetings (e.g. Facilitate medical information request process (Medical Information), patient support program (PSP) and patient advocacy groups

Collaborate with Global Clinical Operations and CCL on early phase trials in the pipeline, phase III, and later phase IV activities (including site and PI lead selection)

Partner and collaborate with Market Access, Regulatory Affairs, and Patient Services to show potential medical value of compounds in development to relevant to local external stakeholders (e.g. payers, HCPs, agencies)

Develop and manage budget(s) for therapeutic areas medical activities, provide input into the affiliate budgeting and planning process; track and adjust performance against plan

Support medical review country‐specific materials to ensure scientific accuracy when needed and clearly express rationale for any objection and sign‐off before release

Serve as back up for the Medical Director or Associate Medical Director, including at key leadership meetings and for materials review or certification, as required

Perform company business in compliance with relevant regulations, company policies and procedures

Advanced degree in a related scientific field, such as MSc (or equivalent) as a minimum, PhD or MD

Minimum 7+ years’ experience within a medical affairs role in the pharmaceutical or biotechnology industry

Experience in a field‐based role (e.g. MSL) is considered an asset

Experience in neurology, rare diseases or neuromuscular diseases is considered an asset

Experience in interaction with health authorities is considered an asset

Ability to convey complex scientific concepts and information tailored to the audience e.g. Key Medical Experts, affiliate staff and regional/global Medical Affairs leadership

Ability to work across multiple digital platforms and early adoption of new systems/applications.

Excellent knowledge of Regulatory Affairs, Drug Safety, Legal and Compliance environment and requirements

Knowledge and understanding of disease area, local health care system, market dynamics, regulations, policies and SOPs, health economic techniques and trends

Demonstrated strategic approach to implementation of scientific communication programs on disease areas and treatments

Language(s):

Fluent in English, both verbal and written with the ability to communicate effectively cross functionally, spanning all levels of the organization

Proficiency in French an asset

Our mission to find therapies for neurological and rare diseases is a unique focus within our industry and this shared purpose is what connects us as a team. We work together to overcome obstacles and to follow the science. We are resilient as we strive to make an impact on our patients’ lives and on changing the course of medicine. At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.

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