Job Description

The Position

The Global Strategy and Medical Capabilities Lead oversees the development and implementation of medical strategies and activities for Headquarters. The Executive Director leads the following teams: Global Medical Strategy, Medical Information (MI) and Designated Point of Contact (DPOC) and Strategic Medical Content and Channels (SMCC). This position will also provide medical expertise, such as responding to patient support requests, reviewing clinical information, performing due diligence, reviewing clinical trials, and interacting with physician KOLs on medical inquiries.

Responsibilities

• Lead teams in the development of Global Medical Affairs Plans (GMAPs) that address asset value proposition, insights from regions/clusters/countries, and clinical and value evidence gaps.

• Help Translate the goals and strategies from the GMAP into research, data analysis, scientific communication, educational, and other tactics and solutions that improve patient outcomes and enhance access, including digital solutions, and patient and customer programs.

• Develop and drive the strategic Medical Capabilities in alignment with the overarching Global Medical Affairs strategy. Ensure the team aligns with the Medical Affairs Outcomes Research (MAOR) Leadership Team (LT) to:

• Facilitate communication and coordination with global, regional and country teams.

• Establish global standards and best practices.

• Implement common tools, training and processes in collaboration with regional teams.

• Provide oversight and ensure the successful execution of key GMAC activities.

• Oversee DPOC intake process and all related audit activities.

• Conduct scientific review of Global Medical Promotional and Non-Promotional materials.

• Respond to Medical Information inquiries.

• Oversees the consolidation of actionable medical insights, from all regions, which help inform Company decisions.

• Represent Medical Affairs in cross-functional long-range planning: work with the Global Franchises, R&D and regions to define Global franchise strategies and Global development plans for their assets; right-size asset tactical plans to life-cycle stage; significantly influence Organon’s Life Cycle Management decisions.

• Support business development assessments by validating unmet medical needs, reviewing asset data (through a Medical Affairs lens) and recommending required Medical Affairs resources.

• Execute on and quickly adapt portfolio of tactics to business realities (i.e., prompt deployment of new information to field medical staff, identification of data analysis and publication needs).

• Support integrated data generation plans and co-develop clinical and outcomes research programs that address life cycle management needs with cross-functional R&D and Observational Research colleagues; advise on areas of interest for the Investigator-Initiated Study Program.

• Provide strategic leadership for: Global Medical Strategy (GMS) (TA Leads and RDMAs), MI, DPOC, and SMCC.

• Provide medical and scientific advice to business units, Market Access/Access Alliance functions and others, as required.

• Adapt and implement the GMAPs in the US through creation of US Country Medical Affairs Plans (CMAP) and Field Execution Plans (FEP).

• Establish and manage Health Care Expert (HCE), health care provider, health systems, governmental agencies, academic societies, and other key stakeholder relationships.

• Provide input into clinical development and value/evidence strategies, as well as local data generation plans.

• Support US Regulatory Affairs in the management of relationships with stakeholders consulted by Regulatory Health Authorities.

• Drive compliance with all applicable Organon guidance documents and SOPs.

• Enhance the Company reputation and profile through an external focus, by representing the Company on cross-company boards and industry associations.

• Ensures compliance with all applicable country regulations.

• Successfully collaborate and lead resolution of Regulatory, Reputational (i.e., Public Relations), Compliance and other Asset issues management.

• Support Medical Affairs in substantive contributions to labeling committees, so that labels contain fair-balanced claims supported by data and are supportive of asset value proposition requirements for most geographies.

Required Education, Experience and Skills

• MD required.

• A minimum of five years of experience working in or with Clinical Development or equivalent as a Medical Director, developing clinical trial protocols, overseeing clinical studies, and/or working with MA teams in preparation for product launch.

• A minimum of five years of global experience in leading teams in the development of field Medical Affairs and strategic Plans that address asset value proposition, insights from regions/clusters/countries, and clinical and value evidence gaps.

• A minimum of five years of experience in developing and driving the strategic direction of a scientific engagement of KOLs and patient engagement strategies in alignment with the overarching Global Medical Affairs and enterprise strategy.

• Ability to lead teams to effectively facilitate communication and coordination with Global, regional and country teams.

• Track record of establishing global standards and best practices, including implementing common tools including FM training, Medical or Ad Promo review, training and processes in collaboration with regional teams.

• Five years’ experience or equivalent in overseeing or contributing to Med Comms, intake teams to ensure the successful execution of key activities, such as Global Medical Content and Training, and MedComm. Participating in the development and review of patient access programs strongly desired.

• Three years of experience in managing DPOC intake process and all related audit activities, conducting scientific review of Global Medical Promotional and Non-Promotional materials, and responding to Medical Information inquiries.

• A minimum of three years working with MA governance teams, asset development teams, or evidence generation.

• Three years of experience in leading Medical Affairs capabilities, including Global Scientific Content, Training, Strategic Pub planning; Global Medical Education, including fee for service and Grants; Global single DPOC for inquiry intake/contact center; Global Medical Information; Medical Review and Consult team; and FM Excellence and Operations.

• Ability to support business development assessments by validating unmet medical needs, reviewing asset data (through a Medical Affairs lens) and recommending required Medical Affairs resources.

• Strategic leadership and thinking.

• Able to effectively collaborate with and influence partners across divisions.

• Minimum of three years’ experience in biopharmaceutical Medical Affairs or R&D management.

• Ability to effectively collaborate with partners across divisions.

• Ability to develop and communicate global/regional strategy.

• Strategic leadership and thinking.

• Strong prioritization and decision-making skills.

• Able to effectively collaborate with and influence partners across divisions.

• Excellent interpersonal, analytical, communication (written as well as oral).

• Results-oriented project management skills.

• Strong Ethics and Compliance mindset.

• Sets the course, sets goals for the good of the company, and thinks and acts with urgency, making necessary changes and appropriate trade-offs.

• Communicates a compelling and inspired vision or sense of core purpose Identifies, attracts, inspires, and develops talent.

• Delivers results, setting high standards for self and others; accepts personal responsibility and sets that expectation for others.

Who We Are:

Organon delivers ingenious health solutions that enable people to live their best lives. We are a $6.5 billion global healthcare company focused on making a world of difference for women, their families and the communities they care for. We have an important portfolio and are growing it by investing in the unmet needs of Women’s Health, expanding access to leading biosimilars and touching lives with a diverse and trusted portfolio of health solutions. Our Vision is clear: A better and healthier every day for every woman.

US and PR Residents Only

If you require reasonable accommodation(s) in completing an application, interviewing, or otherwise participating in the employee selection process, please email us at staffingaadar@organon.com .

For more information about personal rights under Equal Employment Opportunity, visit:

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OFCCP Pay Transparency Rule

Organon proudly embraces diversity in all of its manifestations and is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity, or gender expression, national origin, disability, veteran status or any other characteristic protected by state or federal law.

Search Firm Representatives Please Read Carefully

Organon LLC., does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Applicable to United States Positions Only: Under various U.S. state laws, Organon is required to provide a reasonable estimate of the salary range for this job. Final salary determinations take a number of factors into account including, but not limited to, primary work location, relevant skills, education level, and/or prior work experience. The applicable salary range for this position in the U.S. is stated below. Benefits offered in the U.S. include a retirement savings plan, paid vacation and holiday time, paid caregiver/parental and medical leave, and health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Annualized Salary Range (US)

$245,600.00 - $417,500.00

Please Note: Pay Ranges are Specific to local market and therefore vary from country to country

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R525208