Vacant Positions at MSD

Responsibilities:

• This position will be required to adhere to all relevant requirements, policies, procedures and legal regulations pertaining to health, safety, environment and quality, as well as finance, human resources, and any other regulations as required by the company and relevant to the level of the role and responsibilities of the function.
• Responsible for the achievement of sales targets for our Company’s Oncology Portfolio in a defined region/geography within a country/market.
• Is accountable for accurate execution of territory sales targets planning and operational cross functional territory development plan within assigned territory.
• Able to identify and communicate with relevant customers including Key Opinion Leaders, Oncology decision-making authorities in the cancer institutions and other members of the appropriate Multi-Disciplinary Team (Nurses, Pharmacists, Pathologists, etc.) who are influential in the use of our Company’s oncology products.
• Works in close collaboration with line manager and members of cross functional team be responsible for creation, execution leading and coordinating the activities of other internal Company team members in the same territory (medical, MAx, CDx, policy, communications, etc.) to ensure that the impact of a cross-functional team approach is leveraged.
• Arranging appointments with doctors, pharmacists and oncologists medical teams.
• Be creative in creating access to relevant customers.
• Building and maintaining positive working relationships with medical staff and supporting administration staff e.g., receptionists, chemotherapy room sisters and pharmacists.
• Adhere to operational effectiveness requirements.
• Delivering presentations to doctors and other relevant medical personal within the specific target reach for this portfolio.
• Organizing continued medical education (CME) for doctors and other medical staff.
• Maintains an accurate and up to date picture of the competitive landscape and clinical perspectives within the cancer institutions in their territory.
• Managing budgets (for catering, outside speakers, conferences, hospitality, etc).
• To understand the dynamics of private and government sectors doctors/oncologists and institutions.
• To be able to respond timeously on business issues within a short timeframe.
• Territory analysis: Provide an accurate and reasonable territory potential picture as a basis for short- and long-term territory sales planning; should have a high-level reflex in terms of competition assessment and reporting.
• Maintains an excellent understanding of various processes within the cancer institutions in their territory – e.g., Multidisciplinary Team approaches, Hospital Treatment Protocols for Cancer, Ethics Committee processes, Pharmacy Policies, Formulary Inclusion process, etc.
• In collaboration with and supported by our Company’s Market Access and Logistics colleagues, make sure that there is sufficient inventory at the hospital pharmacy to meet demand of Oncologists / Patients for our Company’s Oncology Medicines (help prevent Out-of-Stocks at any point in time, in collaboration colleagues in Logistics / MAX colleagues, who are end-responsible for sustainable supply of our Company’s medicines to oncology institutions).
• Ensure high level of ethical standards of our Company’s Oncology business in place. 
• Senior Sales Representatives will have a coaching/mentoring responsibility to transfer skills.
• Responsible for reporting adverse experiences or events (AEs), adverse device events (ADEs), product quality complaints (PQCs) and other reportable information, customer feedback (CF), alleged counterfeiting, diversion and tampering (CDT) that they become aware of to the Designated Point of Contact (DPOC)

Qualifications & Experience Required:

• Completed Degree/ diploma in medical or para-medical field is advantageous.
• 3 - 5 years of experience in the following Therapeutic Areas would be preferred: Oncology, Urology and / or Respiratory.
• Surgical sales experience would also be considered.
• Be well organized and have a high work ethic.
• Excellent communication skills.
• Results oriented with ability to meet deadlines and handle challenging assignments. 
• Able to manage complexity.
• Very Good command of English language.
• Very good in Computer skills. 
• Competent presentation skills. 
• Self-motivated and energetic with drive to excel.
• Must have a Valid Drivers’ license. 

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The job duties include the following:

Budget Planning and Resource Management.

• Hires, manages, coaches and develops a group of Medical Affairs Managers/MSLs assigned to his/her therapeutic areas to ensure the highest quality scientific exchange in alignment with the Medical Affairs plan.
• Collates Medical Affairs Manager/MSL field insights that will be shared internally as appropriate.
• Provides input into the therapeutic area Medical strategy led by the local Medical Affairs Managers.
• Ensures that there is adequate and compliant cross-functional collaboration between the Medical Affairs Managers/MSLs and internal stakeholders.
• Organizes regular team meetings for relevant trainings, sharing of best practices, reinforcing on compliance matters and discuss therapeutic area strategies.
• Develop his/her Medical affairs managers/MSLs’ functional and scientific skills.
• Establishes the annual performance objectives for his/her team.
• Conducts mid-year and year-end reviews of team performance.
• Develops and maintains up-to date scientific knowledge around relevant disease areas, products within those areas and research methodologies.
• Ensure optimal scientific leader management and support.
• Develop medical strategy (including the Medical Affairs plan, MAPs).
• Align medical strategy with business unit/franchise-needs with marketing.
• Responsible for the creation and timely execution of all Medical activities in his areas of responsibility including medical education, data generation activities etc...
• Responsible for close follow ups on all systems updates of the activities under his responsibility.
• Review and approves MSL plans.
• Collaborate with GCTO and Market access around new products.
• Ensures that all Medical Affairs Managers/MSLs perform their duties in alignment with company SOPs/Guidelines and local laws and regulations.
• Performs all medical advisor responsibilities for any indications under his/her responsibility.

Skills and Qualification Requirement:

• Medical degree (MD, PharmD,PhD). Preferably MD, Pharmacists or PhD with oncology experience.
• Understanding of the market landscape with deep insight on patient journey, access and reimbursement challenges, and with those challenges seeking opportunities.
• Management experience with direct reports.
• Business acumen, able to understand the business need and align to address patients’ need/unmet gap.

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Position Overview - Basic Functions & Responsibility (may not be limited to):

• For assigned products ensures timely preparation, submission and appropriate follow-up of new Marketing Authorization applications to the local authorities as applicable.
• For assigned products ensures maintenance of assigned, authorized products through timely submission of variations, renewal applications, and supplemental marketing authorizations.
• For assigned products ensures high quality labelling translation and artwork management.
• Supports the agency interactions to ensure a seamless submission, assessment, and quick approval in cooperation with other internal stakeholders.
• For assigned products and tasks, stays updated on relevant local regulations and guidelines.
• Collects relevant publicly available regulatory information (regulatory intelligence) and keeps relevant persons appropriately informed.
• Maintains a positive relationship with internal and external regulatory contacts.

Major Activities (may not be limited to):

New MA applications for assigned products:

• Under supervision, performs timely and correct submissions and approvals of assigned new Marketing Authorization applications in close cooperation with relevant persons in the managing, medical, finance, customer service, marketing, external affairs departments, outcomes research, our Manufacturing Division, GRACS on sub-regional, regional and global level, as well as with local regulatory authorities as appropriate, depending on procedure type.
• Tracks process on products registration and major new indications.

Maintenance of licenses for assigned products.

• Under supervision, ensures that marketing authorizations are maintained in compliance with related regulatory areas, through performing the necessary activities, including variations and renewals, with a high standard and within the agreed timeframes and communicate approvals to stakeholders through the correct processes.

Compliance:

• For assigned products, ensures timely preparation and maintenance of local Summary of Product Characteristics, Patient Package Inserts, local physicians' circulars, packaging material and other applicable regulatory documents according to our company and local standards and relevant Artwork Management procedures. Implement Prescribing Information within the correct timeframes for compliance.
• Ensures that all internal customers receive relevant information with regard to the regulatory status of the assigned products.
• Ensures the correct and proper utilization of Artwork Management System to generate mock-up artwork and to implement revisions to artwork.
• Ensures efficient and consistent implementation and use of internal and external regulatory databases and systems in the country.
• Ensures that files and archives related to Regulatory are kept updated and complete.
• Participates in establishing and maintaining of relevant Standard Operating Procedures to secure that the current regulations are complied with.
• Participates in implementation of updated regulatory documentation according to Agency requirements and in-house guidance.

Labelling and Artwork

• In connection with submission of MA applications and post-approval submissions provides translation and QRD check of Summary of Product Characteristics and Patient Package Leaflets and ensures quality assurance including linguistic check of these documents.
• Prepares artwork, including package leaflets and all other components in a timely and correct manner and according to relevant Artwork Management procedures.
• The incumbent ensures proof reading of packaging components and is responsible for maintaining an updated file on packaging components, as applicable.
• Cross-functional activities, as assigned.
• Secures timely and adequate information and decision making with regard to regulatory issues that need to be brought to the attention of the Management Team, such as deletions, divestitures and acquisitions.
• Takes part in subsidiary product and launch teams to provide regulatory input and strategy advice.
• Adequately supports other functions to enable compliance in areas related to regulatory, such as PSUR submissions and review of promotional material.
• Regulatory policy & environment

Keeps abreast of local and international laws.

• Through active participation in the regulatory work of the local Pharmaceutical Industry Association the incumbent seeks alignment of industry position with our company's interests.
• Shapes the regulatory environment through liaising with the local agency, local pharmaceutical organization and other stakeholders, and in concurrence with the EU Regulatory Policy lead.
• Participates in internal regulatory workgroups.

LOCAL REQUIREMENTS, as applicable

Quality:

• Ensures handling of customer complaints and support product recalls activities according to our standards and local procedure. Closely cooperates with Quality Responsible Person (QRP) / Quality Contact Person (QCP), our Manufacturing Division, Customer Service and/or PhV, QP at wholesaler/distributor/importer level and/or Management (Crisis) team.
• Under supervision by QRP/QCP performs assigned tasks regarding product quality and safety according to local requirements.

Experience and Qualifications Required:

• Minimum BPharm or other life science or equivalent.