Remote Director, Medical Affairs - Medical Information, Training & Communications

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Annexon Biosciences

💵 $238k-$252k
📍Remote - United States

Job highlights

Summary

Join a team committed to making an impact together at Annexon Biosciences, a biopharmaceutical company advancing novel therapies for devastating classical complement-mediated neuroinflammatory diseases. As Director-Medical Affairs Medical Information, Training & Communications (Portfolio), you will lead content creation and training for the entire Annexon Portfolio.

Responsibilities

  • Lead the development of medical content and training for Medical Affairs (MA) team that is aligned with strategic plan and training needs defined by Therapeutic Area (TA)
  • Executes scientific training plans that include but are not limited to disease state, product, competitor, field resources, and congress materials
  • Ensures that the training materials are relevant, scientifically accurate, consistent with appropriate scientific literature cited, internal scientific information, company values, and standards
  • Helps identify digital innovation to support content and training development, access, and delivery including enhanced scientific engagement via remote channels
  • Ensure that all appropriate stakeholders are involved in the development, review and approval of the training materials
  • Leads training to internal stakeholders on just-in-time training on key disease and product related scientific training
  • Leads the development of scientific onboarding program for the field medical teams including the certification
  • Partner and coordinate with business operations training team on training roll out
  • Create a robust training database that will be used by the MA team for all scientific training
  • Develop training materials consistent with adult learning principles
  • Manages materials through the MLR review process
  • Partners with MAs & cross functional team to develop relevant field Medical materials for FMDs such as HCP facing slide decks, CRLs, SRLs along with leading the training of these content across full Annexon portfolio
  • Develop processes and SOPs associated with creation of medical information tools such as CRLs, SRLs, HCP response times
  • Lead the Medical Information efforts in creation and maintenance of global response documents that are scientifically accurate, balanced and that meets customer needs, while utilizing expertise of other Annexon functions
  • Ensure documentation of receipt and response to all medical information requests
  • Supports internal teams by providing literature reviews and medical and scientific information related to Annexon therapeutic areas
  • Develop and maintain relevant knowledge repositories, including medical information responses and publications
  • Ensure the highest degree of quality and medical accuracy for all outputs developed
  • Appropriately liaise with Drug Safety and Quality regarding adverse events and product complaints, ensuring systematic capture and timely reporting
  • Complete all work in accordance with regulatory requirements, industry standards, and Annexon policies
  • Assists in the reporting of key metrics on business process to monitor medical information services
  • Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise
  • Exhibits broad knowledge of assigned therapeutics areas, product labelling and regulatory guidance
  • Serves as MA liaison to cross-functional groups for the incorporation of current medical/scientific information into department documents and processes

Job description

Company:

At Annexon Biosciences we are a biopharmaceutical company advancing a late-stage clinical platform of novel therapies for people living with devastating classical complement-mediated neuroinflammatory diseases of the body, brain, and eye. Our novel scientific approach targets upstream C1q to block the classical complement inflammatory cascade before it starts, and its therapeutic candidates are designed to provide meaningful benefits across multiple autoimmune, neurodegenerative and ophthalmic diseases. With proof-of concept data in Guillain-Barré syndrome, Huntington’s disease and geographic atrophy, we are rigorously advancing our mid-to late-stage clinical trials to bring new potential treatments to patients as quickly as possible. At Annexon, you’ll be part of a team committed to making an impact together.

For more information on Annexon and our pipeline, check out our site Annexon Biosciences & Annexon Pipeline. We trade on Nasdaq under the ticker symbol ANNX and are headquartered in Brisbane, CA.

We seek applicants from all backgrounds to ensure we get the best, most creative talent on our team. We are building a diverse and inclusive workforce – come and be a part of our growth.

At Annexon, we are building a diverse, equitable, inclusive, and innovative company and we are looking for the BEST candidate for the job. That candidate may come from a less traditional background or may meet the qualifications in a different way. We would strongly encourage you to apply – especially if the reason you are the best candidate is not exactly as we describe it here. Learn more about Annexon’s commitment to diversity, equity, inclusion, our values and culture!

Position:

The Director-Medical Affairs Medical Information, Training & Communications (Portfolio) will lead the full content creation including field HCP facing materials training and maintenance of materials for the entire Annexon Portfolio including Neuromuscular & Ophthalmology Therapeutic Areas. This role will require extensive partnership across Medical Affairs to develop strategically aligned content for use across a range of external and internal stakeholders.

Responsibilities include:

  • Lead the development of medical content and training for Medical Affairs (MA) team that is aligned with strategic plan and training needs defined by Therapeutic Area (TA)
  • Executes scientific training plans that include but are not limited to disease state, product, competitor, field resources, and congress materials
  • Ensures that the training materials are relevant, scientifically accurate, consistent with appropriate scientific literature cited, internal scientific information, company values, and standards
  • Helps identify digital innovation to support content and training development, access, and delivery including enhanced scientific engagement via remote channels
  • Ensure that all appropriate stakeholders are involved in the development, review and approval of the training materials
  • Leads training to internal stakeholders on just-in-time training on key disease and product related scientific training
  • Leads the development of scientific onboarding program for the field medical teams including the certification
  • Partner and coordinate with business operations training team on training roll out
  • Create a robust training database that will be used by the MA team for all scientific training
  • Develop training materials consistent with adult learning principles
  • Manages materials through the MLR review process
  • Partners with MAs & cross functional team to develop relevant field Medical materials for FMDs such as HCP facing slide decks, CRLs, SRLs along with leading the training of these content across full Annexon portfolio
  • Develop processes and SOPs associated with creation of medical information tools such as CRLs, SRLs, HCP response times
  • Lead the Medical Information efforts in creation and maintenance of global response documents that are scientifically accurate, balanced and that meets customer needs, while utilizing expertise of other Annexon functions
  • Ensure documentation of receipt and response to all medical information requests
  • Supports internal teams by providing literature reviews and medical and scientific information related to Annexon therapeutic areas
  • Develop and maintain relevant knowledge repositories, including medical information responses and publications
  • Ensure the highest degree of quality and medical accuracy for all outputs developed
  • Appropriately liaise with Drug Safety and Quality regarding adverse events and product complaints, ensuring systematic capture and timely reporting
  • Complete all work in accordance with regulatory requirements, industry standards, and Annexon policies
  • Assists in the reporting of key metrics on business process to monitor medical information services
  • Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise
  • Exhibits broad knowledge of assigned therapeutics areas, product labelling and regulatory guidance
  • Serves as MA liaison to cross-functional groups for the incorporation of current medical/scientific information into department documents and processes.

Location: This position may be on-site at Annexon’s Headquarters in Brisbane, California or remote (within the US)

Salary Range: $238,000 - $252,000

Education, Experience, and Skills:

Required:

  • Advanced Scientific or Medical degree (MD, PhD, PharmD or equivalent) required
  • 6+ years industry experience, working within Medical Affairs
  • Proven expertise in managing vendors for content creation across various Medical Affairs disciplines
  • Significant experience in pharmaceutical or biomedical writing, scientific or corporate communications, including group facilitation and presentation to diverse audiences
  • Able to effectively network and partner with internal and external stakeholders and embrace cross-functional working
  • Strong operational capabilities, eye for detail and commitment to advance and adhere to processes
  • Able to identify inquirer’s question(s) and formulate and communicate an accurate response
  • Able to search the published medical literature, evaluate published scientific information and create balanced and informative responses
  • Understand and demonstrate the importance of providing superior customer service to all clients to support the business
  • Excellent communication skills: verbal, written and when giving presentations
  • Able to thrive as part of a team and when working independently
  • Proven track record of delivering results that meet or exceed targeted objectives
  • Detailed understanding of industry regulations and practices relating to medical information

Preferred:

  • Experience in MA and/or clinical R&D
  • Experience in content management systems similar to Veeva Vault
  • Therapeutic area experience in neurology/neuromuscular, ophthalmology/retina and immunology

Benefits:

  • A stimulating and rewarding workplace includes flexible work schedules, remote opportunities and the ability to achieve a work-life balance.
  • We are located in Brisbane, CA, with shuttle service from BART, CalTrain and the Ferry.
  • Annexon offers a competitive base salary and equity participation, employee stock purchase plan, as well as a comprehensive health benefit package that includes medical, dental, vision, 401(k), flexible spending plans, as well as other benefits.

Annexon Biosciences is an Equal Opportunity Employer, and we prohibit discrimination or harassment of any kind.  We are committed to fostering an environment where ALL people are welcome and supported. We cultivate a culture of inclusion for all employees that respects their individual strengths, views, and experiences. We believe that our differences enable us to be a better team – one that makes better decisions, drives innovation, and delivers better business results. Creativity and innovation flourish in an environment of openness, inclusion, and mutual respect.

Staffing Agencies:

Annexon Biosciences does not accept unsolicited agency resumes and will not pay fees to any third-party agency or firm that doesn’t have a signed agreement with Annexon Biosciences. Please do not send agency CVs/resumes through Annexon’s website or Annexon Employees.  Inquiries must be sent to [email protected] with the Subject:  Staffing Agency Request

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