Job Description
The Position
The successful candidate will collaborate with internal cross-functional project teams and alliance partners to develop and implement world-wide regulatory strategies for assigned biosimilar projects, with a specific focus on Regulatory CMC (Chemistry, Manufacturing, and Controls) requirements. This role includes oversight of assets in various phases of development through registration and post-launch, along with supporting business development due diligence activities.
Responsibilities
Provide global strategic regulatory CMC overview for respective products and portfolio.
Serve as the regulatory CMC point of contact for alliance partners and health agencies, as defined by specific deal agreements.
Collaborate with alliance management and relevant functions to integrate new assets into Organon and lead regulatory sub-teams in both strategic and operational aspects of integration work.
Guide internal R&D stakeholders and teams, along with alliance partners and commercial teams, in creating and implementing global regulatory CMC strategies for the registration, maintenance, and global market expansion of biosimilar products.
Lead the development and implementation of global regulatory strategies by assessing CMC changes, identifying regulatory requirements, and evaluating documentation to confirm acceptability and potential risks.
Execute regulatory strategies by developing, authoring, and reviewing CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals, and responses to health authority questions.
Provide regulatory leadership for product in-licensing, due diligence reviews, product divestment, and withdrawals.
Collaborate with Organon Manufacturing & Supply colleagues and external partners to ensure compliance execution of change management with a focus on regulatory conformance.
Manage the preparation and execution of CMC documentation for post-approval supplement, annual reports, registration renewals, and responses to health authority questions.
Participate in projects and initiatives beyond current responsibilities as needed to drive organizational success.
Provide solutions and manage day-to-day operational issues outside of current responsibilities when needed.
Required Education, Experience, and Skills
Bachelor’s degree, in a science, engineering, or a related field. Fields of study include Pharmacy, Chemistry, Chemical Engineering, Biology, Microbiology, Virology, Molecular Biology, or Biochemistry with at least seven years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field OR
Advanced degree (MS, MBA, Ph.D., PharmD) with at least four years of relevant experience including biological/pharmaceutical research, manufacturing, testing or a related field.
At least one year of direct experience in Regulatory CMC with demonstrated understanding of related pharmaceutical, biological or device operations (e.g., manufacturing, process development, analytical, and quality assurance) is required.
At least five years of relevant experience, including biological/pharmaceutical research; manufacturing, analytical testing; or related fields.
The candidate must be proficient in English; additional language skills are a plus.
Technical Skills:
Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
Leadership Skills:
Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
Demonstrated effective leadership, communication, interpersonal and negotiating skills.
Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
Secondary Language(s) Job Description
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
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
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)
$125,400.00 - $213,100.00Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements: Organon employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
10%Flexible Work Arrangements:
Flex Time, HybridShift:
Valid Driving License:
Hazardous Material(s):
Number of Openings:
1Requisition ID:R533347
#J-18808-Ljbffr weniger ansehenJob Description
The Position
We are seeking an experienced and dynamic Director, Medical Affairs to join our team. The successful candidate will be responsible for developing and implementing strategic medical plans that align with the organization's goals and objectives. This role requires a deep understanding of medical strategy, strong leadership skills, and the ability to collaborate with cross-functional teams to drive medical initiatives.
Responsibilities
Develop and lead the implementation of the medical strategy to support the organization's business objectives.
Collaborate with cross-functional teams, including clinical development, regulatory affairs, marketing and sales, to ensure alignment of medical plans with overall business strategy.
Provide medical expertise and strategic guidance to support product development, regulatory submissions, and commercialization efforts.
Support business development assessments by validating unmet medical needs, reviewing asset data and recommending required Medical Affairs resources.
Support integrated data generation plans and co-develop clinical and outcomes research programs that address life cycle management needs; advise on areas of interest for investigator-initiated trials.
Lead the development and execution of medical education programs and communication plans for healthcare professionals and key stakeholders.
Work with cross-functional teams to identify opportunities for innovative educational programs for healthcare professionals, publications and data generation strategies for assigned therapeutic areas.
Stay abreast of the latest medical and scientific advancements, industry trends, and competitive landscape to inform strategic decision-making.
Establish and maintain relationships with key opinion leaders, healthcare professionals, advocacy groups and other external stakeholders to gather insights and support the medical strategy.
Oversee the planning and execution of medical advisory boards, symposia, and other scientific events.
Manage budgets and resources effectively to achieve organizational goals.
Ensure compliance with all relevant regulations, guidelines, and company policies in the execution of medical activities.
Manage and mentor a team of medical professionals, providing guidance and support to achieve team and individual goals.
Required Education, Experience and Skills
Medical degree (MD, DO) or advanced degree in a relevant scientific field (PhD, PharmD, PA or NP) required.
Minimum of 10 years of experience in a medical strategy or related role within the pharmaceutical, biotechnology, or healthcare industry.
Proven track record of successfully developing and implementing medical strategies that drive business outcomes.
Strong understanding of clinical development, regulatory requirements, and commercialization processes.
Excellent leadership and team management skills, with the ability to inspire and motivate others.
Exceptional communication and interpersonal skills, with the ability to effectively engage and influence internal and external stakeholders.
Strategic thinker with strong analytical and problem-solving abilities.
Ability to thrive in a fast-paced, dynamic environment and manage multiple priorities simultaneously.
Dermatology experience preferred
Preferred Education, Experience and Skills
Experience in dermatology.
Prior experience working in a global or regional medical strategy role.
Proficiency in Microsoft Office and Veeva applications.
Secondary Language(s) Job Description
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
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted 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)
$185,200.00 - $315,100.00Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
RegularRelocation:
No relocationVISA 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:
1Requisition ID:R535226
#J-18808-Ljbffr weniger ansehenJob Description
The Position
Join a dynamic team at the heart of helping Organon to realize its vision of creating a better and healthier every day for every woman. Organon is a global leader in women’s health, delivering medicines and health technologies in the areas of reproductive health, maternal health and conditions that are unique to and disproportionately affect women. Our goal is to deliver innovation, improve access and expand choice to help address the therapeutic gaps in women’s health around the world, and ultimately improve the lives of women globally.
We’re looking for an experienced professional who brings strong leadership and expertise in compliance and learning and development to join our team as the Director, Learning & Development for R&D. This is a key role on the Innovation Strategy and Integration team within Organon’s R&D function.
Responsibilities
Serve as a trusted advisor to the R&D Leadership Team and Quality on learning and development strategies that identify and manage risk for the R&D function, work cross functionally to lead R&D’s efforts to ensure readiness and compliance for audits and inspections;
Execute on the learning strategy as it relates to compliance across R&D with the goal of ensuring compliance and driving organizational priorities;
Liaise with R&D functional areas to identify technical and scientific skill gaps and in turn, design training programs to fill those gaps;
Serve as R&D representative on enterprise L&D initiatives and issues to ensure needs and requests are considered in company prioritization;
Oversee the team responsible for the Organon library of scientific resources and content, engage with stakeholders across the enterprise to better understand their information needs and enable the library team to strategically approach value for all users.
Responsible for engagement strategies for R&D focused on building connections for a globally dispersed employee population, driving organizational priorities and living our values.
Required Education, Experience and Skills
Highly collaborative, outstanding communication and relationship management skills, prior people leadership experience, high EQ
Strong track record for bridging scientific and business constituents, negotiating timelines and willingness to speak up and take the initiative to bring something from idea to implementation – collaborating across the organization to ensure appropriate coordination and alignment
Ability to engage and collaborate with senior leaders around business strategy, outcomes and compliance - make recommendations on strategies that help to manage risk for our function
Resilience and agility to drive and adapt to change while contributing to a culture of continuous improvement
Strong communications and visualization skills to help deliver complex information into consistent views
BA/BS in a scientific or business focused discipline
10+ years in the life-sciences, pharmaceutical industry
Demonstrated knowledge and experience in quality, compliance and learning and development
Strong analytical, organizational and problem-solving skills
Demonstrated leadership and ethics; demonstrated ability to hold others accountable for delivery
Demonstrated ability to work effectively in a team setting, including demonstrated ability in building and managing teams, committees, taskforces etc.
Strong collaboration and problem-solving skills; able to establish good working relationships with employees at all levels, resolve conflict and provide feedback, and to devise and implement creative solutions to problems.
Strong communication skills, both oral and written; demonstrated ability to speak up appropriately and to raise issues to teams and senior management.
Ability to manage through complexity and ambiguity along with competing priorities.
Must have attention to detail and a 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.
Demonstrated sensitivity and knowledge of cultural differences with experience in multi-country, multi-cultural environments and demonstrated success with cross-geographically based cultural collaborations.
Secondary Language(s) Job Description
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
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Poster
EEOC GINA Supplement
OFCCP EEO Supplement
OFCCP Pay Transparency Rule
Organon is an Equal Opportunity Employer. We are committed to fostering a culture of inclusion, innovation, and belonging for all employees and job applicants. We ensure all employment practices are conducted 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)
$152,300.00 - $259,200.00Annualized Salary Range (Global)
Annualized Salary Range (Canada)
Please Note: Pay ranges are specific to local market and therefore vary from country to country.
Employee Status:
RegularRelocation:
No relocationVISA 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:
1Requisition ID:R534041
#J-18808-Ljbffr weniger ansehenHey there! At Evela Health, we're on a mission to totally change women's health, starting with menopause. We're building a super personalized, AI-driven digital clinic from scratch. We're a startup, so we're all about moving fast and making a real impact. Right now, we're on the hunt for a Chief Technology Officer (CTO) who's ready to roll up their sleeves and build our tech from the ground up, lead the charge, and help us scale. If you're a hands-on coder who loves setting the technical vision and building an awesome engineering culture, this might be your gig!
TasksYou're the Lead Builder: For at least the first year, you'll be coding like crazy – think backend, mobile, integrations, deployments, the whole thinh.Own the Tech Stack: You'll be in charge of everything from designing the architecture to making sure the code is solid, deployed, monitored, and maintained.AI Whisperer: You'll be designing and implementing our AI systems, like recommendation engines, to give women super personalized health outcomes.Data Defender: Keeping all that sensitive health data secure and compliant with GDPR? That's on you.Team Captain (Eventually): Once we grow, you'll be hiring and leading our engineering team, setting up our engineering practices, and building a cool culture.Product Pal: You'll be teaming up with our Co-CEOs and the product founder to hammer out the product roadmap.RequirementsPassion for Building: Seriously, you live to ship code and see people use what you've created.Startup Savvy: You've been in the trenches with early-stage startups or launched V1 products with lean, agile teams.Tech Guru: You've got a solid background in backend dev, infrastructure, and getting mobile apps out there.AI Experience: You've built and scaled AI-powered applications, especially ones that folks actually use.Communication King/Queen: You can inspire a team, get everyone on the same page, and aren't afraid to jump in and help out.5+ Years of Coding: You've got the chops, and if you've worked in health tech before, that's a sweet bonus.AI Enthusiast: You're hyped about how AI can change software development and you're already using it.BenefitsMeaningful Mission: You'll be literally transforming women's healthcare – how cool is that?Build from Scratch: This is your chance to architect and build a high-impact product from the ground up.Goodies: We're talking competitive pay, equity options, and a solid benefits package.Flexibility: Work from wherever you're happiest, or join us in our Berlin office for team days.Leadership Table: You'll be a key player on the founding team, shaping the whole company's future.Ready to join us ? If you're a talented CTO who's passionate about building awesome products and making a real difference in women's health, we'd love to chat!
Updated: 1 day agoJob ID: 14513767Report issueEvela Health GmbH1-10 employeesHealth and Human ServicesEach year, 47 million women enter menopause without access to the healthcare solution they need to thrive. We understand because we have been there ourselves. That's why we founde…
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