Senior Manager, Medical Affairs - Neuropsychiatry

at  Biogen

Toronto, ON, Canada -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate18 Jul, 2024Not Specified18 Apr, 20247 year(s) or aboveBiotechnology Industry,Rare Diseases,Leadership Skills,Regulations,Neurology,Regulatory AffairsNoNo
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Description:

Job Description
Job Purpose:
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.

Responsibilities:

  • 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. KME engagement, unsolicited HCP sponsorship requests, etc.)
  • 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
  • Facilitate sharing of best practices and knowledge across therapeutic area(s)
  • 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
  • Participate and support regular MSL team meetings (affiliate level); represent affiliate, where required, at TA‐specific meetings
  • Perform company business in compliance with relevant regulations, company policies and procedures
  • Other duties as assigned

Qualifications

Education:

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

    Experience, including # of years:

  • 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

    Skills:

  • 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
  • Has demonstrated leadership skills and acquired knowledge and skills/competencies to the degree expected at job level

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

Additional requirements:

  • Ability to travel as needed up to 30‐40% of the time

Additional Information

Responsibilities:

  • 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. KME engagement, unsolicited HCP sponsorship requests, etc.)
  • 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
  • Facilitate sharing of best practices and knowledge across therapeutic area(s)
  • 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
  • Participate and support regular MSL team meetings (affiliate level); represent affiliate, where required, at TA‐specific meetings
  • Perform company business in compliance with relevant regulations, company policies and procedures
  • Other duties as assigne


REQUIREMENT SUMMARY

Min:7.0Max:12.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

MSc

Proficient

1

Toronto, ON, Canada