5 days old

Sr. Manager Global Medical Affairs

Indivior
Richmond, VA 23219
  • Job Code
    R1314
TITLE:
Sr. Manager Global Medical Affairs

Title: Sr. Manager Global Medical Affairs

Reports to: Director Medical and Promotional Review; Global Medical and Safety

Location: Remote

Indivior is a global specialty pharmaceutical company with a 20-year legacy of leadership in patient advocacy, health policy and evidence-based best practice models that have revolutionized modern addiction treatment. The name is the blend of the words individual and endeavor, and the tagline "Focus on you" makes the company's commitment clear. It represents and empathizes with the often-difficult journey each individual patient takes to overcome the challenges of addiction - a chronic relapsing disease.

Indivior is dedicated to transforming addiction from a global human crisis to a recognized and treated chronic disease. The Indivior logo radiates its patient-focused, holistic focus on expanding access to quality treatment for addiction worldwide. The company has a strong pipeline of products and candidates designed to both expand on its heritage in global opioid dependence and address other chronic diseases of addiction - including opiate overdose, alcohol use disorders and cocaine intoxication - as well as related mental health disorders such as schizophrenia.

POSITION SUMMARY:

The Sr. Manager Global Medical Affairs is a subject matter expert (SME) for an assigned product/therapeutic area and an integral member of the Global Medical Affairs and Safety team and has responsibility for the development, review and approval of high-quality scientific content and educational resources to support the educational and scientific training needs of Medical Affairs, including Medical Science Liaisons (MSLs), Medical Outcomes and value evidence Leads (MOVL), and Medical Information. This SME will be responsible for creation and communication of scientific engagement materials and will be responsible for the review and approval of Medical Promotional materials. The individual will collaborate/align cross-functionally with key stakeholders to build Medical Affairs scientific content.

The role will review and approve scientific exchange and educational materials for scientific accuracy as part of the Medical Review Committee (MRC) Approval and Compliance process, contribute to the development of scientific resources, including slide decks, Medical Information letters, and collaborate with medical field teams regarding medical insights to inform development of scientific content, and analyze medical literature to inform medical strategies and tactics and manage project-associated budgets and vendors.

The role will also assist and in addition serve as a back-up medical reviewer on the Promotional Review Committee for the review of promotional materials upon required training and mentoring. This person can serve as a primary medical reviewer when he/she has gained the training, experience, awareness of promotional review guidelines, and mentoring required to successfully perform this role. As subject matter expert and representative from Global Medical Affairs and Safety, provide medical review of promotional materials, ensuring that clinical/scientific data presented in the materials are accurate, objective, scientifically balanced and not misleading.

ESSENTIAL FUNCTIONS:

The responsibilities of this job include, but are not limited to, the following:

  • Strategize and develop high-quality scientific content related to Indivior's products, as well as Therapeutic Areas specific disease state training materials inclusive of reactive/proactive slide decks to support the educational and scientific training needs of Medical Affairs, including MSLs, MOVL leads and on-boarding Medical Affairs colleagues
  • Assist with the creation and updating standard medical information content on Indivior products utilizing the highest level of evidence; critically evaluate the data with the focus that the information can be shared with HCPs by all Indivior local operating companies
  • Create and update medical information payer content by collaborating and building a strong relationship with our partners (e.g., US Medical Affairs, Medical Outcomes and Value Liaisons (MOVL), Legal) so that payer and managed care organizations have the necessary resources they need to make decisions regarding Indivior products
  • Collaborate with FMP to create topic-specific presentations as requested by HCPs to share new information regarding an Indivior product/Indivior-relevant therapeutic area or help fill knowledge gaps
  • Collaborate with internal business partners (e.g., Medical Affairs, FMP and Commercial) to ensure the provision of medical information such as promotional materials, speaker presentations, and field training materials related to an Indivior product or related disease state; ensure medical accuracy and scientific balance during the promotional review process
Collaborate with Medical Affairs, FMP and Commercial to prepare for the launch of a new product, new indication or new clinical data (e.g., creation of a medical information database, dossiers, therapeutic slide deck, promotional materials, trainings of Medical colleagues and speaker trainings)
  • The role will assist and also serve as a back-up medical reviewer on the Promotional Review Committee for the review of promotional materials upon required training and mentoring. This person can serve as a primary medical reviewer when he/she has gained the training, experience, awareness of promotional review guidelines, and mentoring required to successfully perform this role. As subject matter expert and representative from Global Medical Affairs and Safety, provide medical review of promotional materials, ensuring that clinical/scientific data presented in the materials are accurate, objective, scientifically balanced and not misleading
  • Serve as medical reviewer on the medical review committee for scientific engagement materials to ensure medical accuracy and scientific balance during the process. Also ensure materials are appropriately references/linked within the DMS, contain necessary contextual information and as applicable, reflect relevant and timely scientific and clinical data about the product or subject of the material.
  • Develop and update scientific slide decks on Indivior products and disease state content for external HCP education delivered via Field Medical Affairs Scientific Education Programs
  • Assist and collaborate with the Medical Affairs Leads and Publications Lead to ensure strategic alignment with asset specific integrated Medical Communication and Publications Plans, including alignment with the Scientific Communication Platform and timely communication of information
  • Proactively identify needs for new scientific content/update existing content based on insights and inquiry trends to address unmet educational gaps
  • Collaborate with MSL's, MOVL's and medical information regarding evaluating insights to inform development of scientific content
  • Develop product and disease state expertise and keep abreast of the changing drug development environment, as well as provide support as a content expert on the development of pipeline resources
  • Ensure that all developed materials are reviewed and appropriately signed off according to Indivior Policies and SOPs and maintain archive of approved materials within the appropriate management system
  • Contribute to the development of the strategic vision and strategic medical affairs plans for the Medical Communications function and core capabilities in support of adding value to the organization

MINIMUM QUALIFICATIONS:

Education: Doctor of Pharmacy

Field of Study: Clinical Pharmacy

Experience: Min 2 years of experiences related to either clinical, medical information and medical communication experience. At least 2 years' experience in a pharmaceutical company. Specialty Residency and/or post-doctoral training in a pharmaceutical industry is a plus. Experience with Veeva is required.

At least 2 years of extensive and relevant scientific experience (communicating and translating scientific evidence) in a pharmaceutical, managed care, or Health System setting.

Experience communicating and translating evidence and customer insights to/with matrix team partners. Strong biomedical literature evaluation skills.

Other: Proof of pharmacist licensure required. Understanding of legal/regulatory/compliance requirements and guidelines surrounding medical communications within the pharmaceutical industry including but not limited to ACCME standards, PhRMA Code and OIG guidance

COMPETENCIES/CONDUCT:

In addition to the minimum qualifications, the employee will demonstrate:

  • Strong understanding of scientific literature and analysis to support the provision of medical engagement through written or verbal communication.
  • Ability to work independently and manage/prioritize multiple projects simultaneously
  • Ability to approach issues from a number of perspectives, researching and summarizing data to draw a conclusion
  • Excellent verbal and written communication skills
  • Individuals in this role work within a highly-matrixed and dynamic internal team environment.
  • This role requires strong communication and active listening skills, professional maturity, and business acumen.
  • Facilitation and problem-solving skills, along with an ability to drive a group to action/decisions, will be required.
  • Ability to systematically perform activities in a timely and accurate manner

GUIDING PRINCIPLES:

Indivior's guiding principles are the foundation for each employee's success and growth. Each employee is expected to demonstrate understanding and adherence to our guiding principles in their everyday performance.

The duties and responsibilities identified in this position description are considered essential but are not limited to only those outlined. The employee may perform other functions that may be assigned. Management retains the discretion to add or change the duties of this position at any time.

EQUAL EMPLOYMENT OPPORTUNITY

EOE/Minorities/Females/Vet/Disabled





Posted: 2021-09-11 Expires: 2021-10-10
Sponsored by:
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Sponsored by:
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Sr. Manager Global Medical Affairs

Indivior
Richmond, VA 23219

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