Sr. Manager, Label Writing

Job Description

Organon – Sr. Manager, Label Writing

THE OPPORTUNITY

Our Regulatory Affairs / Pharmacovigilance team brings new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

WHAT WILL YOU DO:

• Overall accountability for the initial creation and updates to labeling documents for assigned products including development and maintenance of Core labeling, US labeling, and their associated patient labeling documents, and target product labels. Includes the responsibility to work cross-functionally and lead meetings to develop, review and approve labeling documents.
• Operates as the primary point of contact on assigned products for all internal and external stakeholders to ensure timely regulatory submissions , quality and compliant labeling documents, and to support business objectives. Includes support required for audits/inspections related to assigned products.
• Provides project management throughout the entire process, from the request to update a Core/US labeling through notification to stakeholders, in order to ensure documents are produced in a timely manner according to internal operating procedures and external regulatory requirements. Includes the responsibility to manage communication plans, distribution of labeling documents, updates to labeling tracking reports and databases, and providing status updates to Global Labeling management.
• Knowledgeable about key labeling requirements worldwide and ensures that country labeling documents are aligned with the Core or reference labeling documents.
• Provides regulatory expertise and guidance for the development and submission of US labeling components. Controls the consistency of US labeling content through alignment with the Core Labeling, across product families where necessary, and with all applicable best practices.
• Assists with creation/update of local product labeling (EU and most of world) for assigned products and interfaces with Regional Labeling Lead and local country affiliate colleagues to support timely and quality regulatory submissions and approvals globally.
• Supports the use and development of current and new tools, technologies and processes to support efficient global label development and worldwide submissions and approvals.

WHAT YOU MUST HAVE:

• Bachelor’s degree in a scientific or medically-related discipline required. Master’s degree preferred.
• Minimum of 4 years of pharmaceutical experience or relevant professional experience.
• Knowledgeable about the scientific principles of the drug development process.
• Must have proven track record to be able to think critically, strategically, independently and problem solve
• Must have high level of motivation, drive, and demonstration of Organon leadership values
• Excellent written and verbal communication skills including ability to write clearly and concisely
• Top notch interpersonal skills in difficult situations
• Driver of change and innovation
• Ability to work seamlessly with all levels of personnel
• Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations
• Excellent word processing, sharepoint, excel, e-mail, and online meeting tool skills

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.

At launch, we will be more than 10,000 Founders strong, ready to rise together as we make a difference in a new way. As Founders, employees will create their future and will help shape the direction of Organon and its impact on the world. Our culture reflects our passion for those we champion.

At Organon, we all belong. We embrace diversity and give it a voice. Our commitment to supporting women is reflected in the make-up of our leadership team, which is majority female and our diversity of experience is core to who we are and what we are designed to do.

We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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.

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.

Employee Status:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

Requisition ID:R501115