At VIATRIS, we believe healthcare not as it is but as it should be. We act courageously and are uniquely positioned to be a source of stability in a world of evolving healthcare needs.

Viatris empowers people worldwide to live healthier at every stage of life.

We do so via:

• Access – Providing high quality trusted medicines regardless of geography or circumstance;
• Leadership – Advancing sustainable operations and innovative solutions to improve patient health; and
• Partnership – Leveraging our collective expertise to connect people to products and services.

Every day, we rise to the challenge to make a difference and here’s how this role will make an impact:

POSITION PURPOSE

A brief summary of the purpose this position must fulfill.

Global Clinical Strategy Lead (GCSL) is a strategic role with in the Global Clinical Strategy and Innovation Department, which is primarily responsible for review and evaluation of external and internal product opportunities from a clinical strategy and development perspective in collaboration with cross functional departments. The person will provide medical and strategic leadership in identification, evaluation, and clinical due diligence of differentiated and novel products in the assigned therapeutic area. GCSL will also be responsible for providing clinical strategic program leadership for the clinical development of assigned products. This position will lead a highly matrixed organization to establish, develop and execute robust clinical development programs in assigned therapeutic areas across various verticals. This role works collaboratively with Global Business Development (GBD), Portfolio, Global Commercial Development (GCD), Global and Regional Medical Affairs, Global Clinical Operation Leads, Biometrics, Regulatory Affairs, Development Program Leaders, PK-DM Scientists, Vertical R&D Leaders, and other key internal stakeholders to achieve the goals of the organization. Ensures compliance with the Standard Operating Procedures (SOPs), current Good Clinical Practices (GCP), and regulatory requirements.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Identification and evaluation of product opportunities developed internally or externally in the assigned therapeutic area
• Supports or leads multidisciplinary teams in assessing potential product opportunities, driving an integrated approach for the review, evaluation and recommendation for the clinical part of global (and regional or local as applicable) product evaluation
• Provide medical and clinical development expertise for the evaluation of internal and external R&D opportunities
• Responsible for the assessment of the appropriateness of clinical development plans suggested by partners or developing clinical development plans (including budget and timelines) for in-licensing deals under consideration. Responsible for the evaluation of products from clinical regulatory requirements based on the prevailing regulatory guidance and clinical best practices
• Works closely with Global BD, Global Commercial Development and Global R&D to support business cases by providing information on TPP, product positioning, competitive landscape, clinical development milestones, costs and probability of technical success.
• Maintains a strong network of subject matter experts within the organization across functions and key opinion leaders outside the organization to get insights for product evaluations and assigned clinical development programs
• Integrate scientific rationale, regulatory requirements, target product profile, product development plan and commercial goals to build and optimize a clinical development plan (CDP) and gain approval from internal and external stakeholders
• Generate estimates for cost and timelines to execute the CDP with the support from global clinical operations (GCO). Estimate the probability of clinical development success for the calculation of overall PTRS (probability of technical and regulatory success). Incorporate key decision points and clinical criteria for Go-No-Go decisions.
• Serve as Clinical Sciences Study Lead (CSSL) for the assigned clinical development programs. Plans, designs and oversees clinical programs as required throughout all stages of drug development with operational assistance from a clinical operations team and program management team. Accountable for clinical protocol and study report content. With clinical team, tracks emerging clinical profile of the drug, keeps line management informed of changes in the profile as they occur. Must be fully knowledgeable about the clinical profile of programs on which studies are being conducted or which are called for in the protocol.
• Leads other team members in the data review, analysis and reporting of assigned clinical studies, with responsibility for overall content and accuracy of study report and final sign-off.
• Serve as the Sponsor Medical Monitor (MM) for clinical trials, to address patient eligibility and protocol questions in cooperation with the contract research organization (CRO) MM. Conducts a periodic clinical oversight of assigned clinical development programs as per the Standard Operating Procedures (SOP).
• Clinical contributions to all regulatory documents including Investigator Brochures, regulatory advice meetings, NDA/MAA. Leads the resolution of clinical queries from drug regulatory agencies, takes a lead role in reviewing responses to regulatory queries.
• Stays abreast of literature, government guidelines, internal guidance on clinical trial conduct, including Good Clinical Practice and internal SOPs, regulations for specific projects to which assigned, in order to be a team resource in terms of both medical background and clinical trial design.
• Ability to produce and present quality scientific papers at external meetings and for publication. With line management endorsement, manage and initiate external collaborations with world leading clinical experts to forward clinical science in assigned therapeutic area.

QUALIFICATIONS

EDUCATION/EXPERIENCE

• Medical degree along with post-graduate training like MD/MBA/PhD and 5 to 10 years of relevant clinical development, clinical strategy or clinical due diligence experience. However a combination of experience and/or education will be taken into consideration.
• Must set a vision for the successful clinical progression of drug candidates and inspire others to excel and constantly strive to succeed.
• Constantly challenges existing paradigms in clinical research and encourages use of breakthrough designs based on an understanding of clinical methods, biomarkers and new technologies

LICENSES/CERTIFICATIONS

• Licensed medical practitioner desired
• MBBS+MD is Mandatory

WORK ENVIRONMENT

The work environment characteristics described here are representative of those an employee encounters while performing the essential duties of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential duties.

Normal office situation. Periodic travel is required.

Deputy Manager – Medical Writing

Role Purpose

The Senior Medical Writer (SMW) is responsible for writing and reviewing scientific publications, clinical documents, critical regulatory documents/submissions, and other essential documentation. SMW will ensure timely drafting, review, approval and submission of high quality documents while collaborating with global teams (like Medical Leads, Clinical development, Biostatistics, ClinPharm, Safety, Regulatory, etc) , external reviewers and vendors. SMW may be required to assist senior staff in the development and implementation of departmental processes and guidelines.

Key Responsibilities

Prepares publication plans for Viatris Assets, manuscripts for submission to peer reviewed scientific journals, abstracts, posters, and slide decks for Congress.

Prepares protocols, clinical study reports, integrated summaries, investigator brochures, annual reports for regulatory submissions.

Facilitates document-review meetings and provides comments-consolidated documents for these reviews.

Leads multiple medical writing projects simultaneously in an international matrix environment.

Proactively manages and escalates up risks to quality, timelines, and compliance.

Provides inputs for innovation in processes and quality standards for producing high quality documents.

Collaborates with external vendors to ensure high standards for submission documents and services provided.

Ensures inspection /audit readiness, SOP, and training compliance.

Aligns with the organizational initiatives, standards of performance and behavior by identifying and working on strengths and improvement areas.

Performs other duties as requested by management.

Supervisory/Management Responsibilities

• No supervisory responsibility

Position Accountability Scope

Scope of the role Global

Own: Global Medical Writing

Influence: Global medical-country medical-clinical development

Qualification and Experience

• Medical Writing experience of 8-10 years
• Master’s degree preferred.
• Doctorate degree would be an added advantage.
• Certification of CMPP and BELS would be an added advantage.

Understanding of Drug development, scientific research, pharmaceutical environment

ICH, FDA and ICMJE requirements

Level of English proficiency required for this role: Advance

IT Platform Lead – R&D and Regulatory Affairs

KEY RESPONSIBILITIES

Works with teams globally for end-to-end implementation of various GxP R&D and Regulatory Affairs systems to ensure compliance with regulations by FDA, EMA and other health agencies

Leads the creation of project management plans that clearly define the project scope, assumptions, risks and overall project approach including project resource needs, high level timelines, and project communications.

Develops and administers project budgets, schedules, and performance standards.

Coordinates and responds to requests for changes from original scope.

Assigns duties, responsibilities and scope of authority to project personnel. Directs and coordinates activities of project personnel to ensure the project progresses in scope, on schedule and within budget.

Drives compliance with the IT Quality processes and Viatris SDLC process, including the IT change management and quality/testing process.

Analyzing scope of work to define the project goals, prioritize the project activities as per the project plan and manage resources.

Responsible for ensuring completeness of Statement of Work to mitigate future conflicts by binding scope and foreseeing the project needs; keeping budget, timelines and scope of work in consideration

Enforcing Systems Development Life Cycle standards and required regulations to projects.

Collaborates with key users of various functions of R&D and Regulatory Affairs across geographies.

Drive the project delivery to ensure conformance to predetermined schedule, budgets & milestones of the projects.

Communicates project status to project steering committee and other stakeholders as appropriate. Manages project issues/risks in a timely manner and appropriately escalating when necessary.

Provides leadership and motivation to direct reports and project management resources. Mentors, coaches, and trains others.

Assist other project managers on the team by providing technical expertise to architect solutions, ensure secure IT solutions are implemented, troubleshoot issues, and adhere to Viatris best practices and SOPs.

Liaise with business partners and technical staff at the Global Infrastructure Development Center on behalf of the R&D IT application group during daytimes hours in IST time zone.

Partner with run support team, directing and educating them as needed to improve the support of electronic systems used to support Viatris regulatory and scientific affairs business units.

Discover and lead novel ways of getting solutions put into place by leveraging expertise across the organization.

Responsible for providing system ownership and support for R&D and Regulatory Affairs systems which includes partnering with IT support teams to maintain deployed solutions

Guide other system owners on maintenance processes and improvements as well as troubleshooting and resolving issues together with support teams.

Collaborate with key global business users to elicit and refine requirements for various functions of R&D and Regulatory Affairs) as well as collaborate with solutions lead to ensure proposed technologies are meeting requirements

Escalate issues and concerns to leadership and proactively work together on timely solutions.

Veeva RIM Registrations technical subject matter expert leading system integrations, administration, configurations, design, and development including all facets of application implementation

Other duties as assigned

QUALIFICATIONS

KNOWLEDGE

Must possess extensive knowledge of project management concepts, practices and procedures as they relate to the delivering IT project.

Must understand and apply all of the Project Management Body of Knowledge Competencies.

Prior experience of working with R&D and Regulatory Affairs is be preferred.

Knowledge of Veeva RIM Registrations and Submissions Vaults is preferred.

SKILLS AND ABILITIES

Achieves high results through people.

Demonstrates strong oral and written communication skills.

Works well in and appreciates the value of a globally diverse management, employee, and contractor environment.

Performs well under pressure. Shows diplomacy, tact and good judgment when conflict arises.

Proactively plans for managing and mitigating project risks.

Is able to see the larger picture, able to identify patterns or connections between situations not obviously connected; able to identify key issues in complex situations.

Knows when and when not to act authoritatively in order to obtain maximum performance from colleagues.

Possesses a clear vision of project direction/outcome and ability to communicate this vision; instils a sense of project ownership.

Navigates corporate situations and diffuses potentially volatile situations; is able to tap into the power structures of organizations.

SUPERVISION

Position functions autonomously and has direct reports. Receives abstract assignments. Carry out supervisory responsibilities in accordance with the organization’s policies and applicable laws. Responsibilities encompass completing or delegating the following processes including interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems.

EDUCATION/EXPERIENCE

Minimum of a Bachelor’s degree (or equivalent) and 8 years relevant experience with Master’s Degree is preferred. However, a combination of experience and/or education will be taken into consideration.

LICENSES/CERTIFICATIONS

Veeva certification preferred. PMP certification is preferred.

LANGUAGE SKILLS

Ability to read and interpret complex business and/or technical documents. Ability to write comprehensive reports and detailed business correspondence. Ability to work with groups of people such as other departments and communicate known concepts. Ability to present to a group of departments.

MATHEMATICAL SKILLS

Has an understanding of earned value metrics and how to use them effectively on projects.

REASONING ABILITY

Ability to solve complex problems with a variety of variables through nonstandard solutions that require in-depth analysis. Ability to draw inferences and follow prescribed and detailed procedures to solve complex problems.