SHEBA MATHEW, PhD

Training and Curricula Development

Development and execution of the Obesity and cross-TA training and scientific resource plan

• Accountable for the development and execution of the Obesity and cross-TA training and scientific resource plan using multimodal and varied training techniques to enable FMA team to communicate with maximal impact
• Facilitated cross-functional collaboration for improved decision-making processes within the organization.
• Oversaw the creation and revision of obesity new hire material as well as training curricula for new therapeutic areas/areas of study
• Led cross-functional teams staying on top of challenging schedules with multiple competing timelines.
• Managed budgets effectively to ensure optimal use of resources.

Strategic Projects

Implemented award-winning, innovative solutions to solve complex problems

• Long standing member of Core Medical Teams Obesity.
• Led the development of market landscape assessments
• Responsible for the development of content for Obesity Medical Booths
• Oversaw the development and execution of cross-functional, proof-of-concept patient medical interface mapping project that provide insight to the patient/HCP medical touchpoints along the healthcare ecosystem
• Oversaw the development and execution of virtual advisory boards with stakeholder groups providing insights that would support Medical Affairs engagements

Launch Planning

Integral to the execution of successful product launches

• Responsible for development and execution of FMA training within several product launches (Wegovy, SELECT and various other label updates)
• Medical lead for Rebynin product launch
• Enhanced stakeholder launch preparedness with timely and transparent communication strategies.
• With Wegovy launch collaborated with Global and NNI Medical Affairs to implement several "first time ever" practices that became best practices for future launches (ie advance receipt of data, early drafts of manuscripts, Global Medical Directors involvement in training sessions)

Team management

10 years plus of team management that spans different functional areas in medical

• Trained and guided team members to achieve their potential
• Assisted in recruiting, hiring and training of team members.
• Established a culture of continuous improvement by fostering open communication channels and empowering employees to voice their ideas.
• Enhanced team collaboration through regular communication, goal setting, and performance evaluations.

• Developed the Medical Affairs Strategy within Hemophilia & Rare Bleeding Disorders, Growth & Growth Hormone Disorders, and Obesity therapeutic areas
• Developed and had oversight of medical strategy and tactical plans for hemophilia launch product in alignment and coordination with US, global marketing and medical affairs teams
• Represented Biopharm Medical in cross-functional team that addressed the Novo Nordisk/Baxalta litigation and simulation scenarios
• Commissioned and oversaw delivery of clinical landscape assessments that served to support medical strategic opportunities
• Delivered medical/clinical recommendations based on competitive intelligence and clinical insights across portfolio to support the current and future commercial and scientific objectives of the company
• Developed Key Opinion Leaders, Patient and Advocacy Organizations engagement strategies across therapeutic areas to support corporate commercial and scientific objectives
• Established KOL identification, mapping and segmentation projects
• Oversaw development of strategic field medical training curricula for Obesity, Hemostasis & Rare Bleeding Disorders, Growth & Growth Hormone Disorders Medical Liaison and Managed Markets field teams
• Led clinical insight strategy, analysis, and communication for Field Medical Affairs teams and key internal stakeholders
• Identified new, cost-effective solution for gaining insights from external advisors via a asynchronous virtual advisory board
• Provided input to and medical support for US KOL advisory boards and focus groups
• Represented Medical Affairs on Global Project Teams, Global Publication Planning Team, US Strategy and Operations Leadership Teams, commercial LCM planning team, Clinical, Medical and Regulatory (CMR) Collaboration Teams
• Monitored annual project spend across therapeutic areas

• Resources allocation across 5 direct reports according to business and regulatory priorities
• Ensuring high-quality medical writing support for medical, regulatory, clinical, marketing, and managed care needs across drug, device and therapeutic areas
• Defining and implementing departmental strategies
• Identifying new opportunities for increased scope of work across NNI and globally
• Established first Project Medical Writer role outside Copenhagen
• Assisting head of the department with the management of travel and operational budget

• Identification of US publication/HCP knowledge gap as foundation of US pub strategy aligned with corporate objectives between NNI and Global
• Chairing first NNI cross-functional publication planning group (PPG) in hemophilia, hormone therapy and growth hormone disorders
• Ensuring vendor contracts, process and projects are correct, compliant and complete
• Ensuring adequate medical writing resources for 4 therapeutic areas and Strategic Scientific Communication (SSC) department
• Authoring publication planning policy for NNI
• Guiding and mentoring medical writers and e-publishers during the production and electronic publishing of documents that support the regulatory, publication, marketing, and medical affairs needs of NN therapeutic products (hemophilia, growth hormone, hormone therapy, and inflammation)
• Managing USD$1M+ publication and vendor budget across 3 therapeutic areas

• Guiding the production of documents that support the regulatory, publication, marketing, and medical affairs needs for NN therapeutic products
• Assisting with the development and implementation of training, processes and policies within the Strategic Scientific Communication department

• As Senior Writer, I was additionally responsible for organizing, conducting, and leading document production meetings
• Working within Scientific Information to understand and implement document preparation procedures and SOPs
• Working with HQ staff to assist with the review and preparation of global registration documents
• Assisting other medical writers, as per project timeline and workload demands

• Responsible for creating scientific content for regulatory documents (CTRS, sBLAs, Orphan Drug Applications)
• Prepared manuscripts, meeting abstracts, scientific poster presentations, and other items necessary for publication support
• Acted as the primary contact for hemophilia and critical bleeds therapeutic areas

• Analysed Clinical Study Reports (CSRs) and Study Protocols to assist in proposing publication hypothesis and purpose
• Ensured unique viability of publication hypothesis by performing literature searches in Medline, Embase, as well as popular Web sites and consumer-based articles
• Relationship building with Key Opinion Leaders
• Developments of short-term and long-term publication and communication strategies
• Peer-reviewed journal publications, consumer articles, slide kits, continuing medical education materials, product monographs, posters, abstracts, and formulary dossiers
• Developed content for educational symposia and meeting reports

• Identified essential and novel bacterial genes as targets for antibacterial therapeutic agents

• Conducted in vitro and in vivo immunology-based transplantation studies to identify novel targets for therapeutic agents