Senior Manager, Regulatory Management

4 weeks ago

Canada Biogen, Inc. Full time

Senior Manager, Medical Affairs - Neuropsychiatry
Full-time
Reporting to the Medical Director, the Sr. Medical Manager, Medical Affairs is responsible forleading medical strategy and activities for Neuropsychiatry, other therapeutic areas may beassigned as needed. Co‐create medical strategy in assigned therapeutic area(s), with focus on field strategy, andimplement medical tactical plans in alignment with cross functional partners (e.g. Sales andMarketing Managers) and Medical Director
Accountable for overall KME engagement planning in assigned therapeutic area(s) and fieldengagement metrics (qualitative, quantitative); monitoring and reporting; 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 intherapeutic area
Accountable for congress strategy at scientific meetings (e.g. Facilitate medical information request process (Medical Information), patient supportprogram (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 toshow potential medical value of compounds in development to relevant to local externalstakeholders (e.g. payers, HCPs, agencies)
Develop and manage budget(s) for therapeutic areas medical activities, provide input intothe affiliate budgeting and planning process; track and adjust performance against plan
Support medical review country‐specific materials to ensure scientific accuracy whenneeded 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 keyleadership meetings and for materials review or certification, as required
Language(s):
~ 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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