Top 13 Regulatory affairs Jobs in Fishkill, Ny

Senior Associate Director, Medical Affairs Strategy Team Member - Pulmonary ILD (Hybrid)
BI Pharmaceuticals, Inc. —Ridgefield, CT
- Full-time
- 18 years or older
- 7 years
- Bachelor of Science
Senior Associate Director, Medical Affairs Strategy Team Member - Respiratory (Hybrid)
BI Pharmaceuticals, Inc. —Ridgefield, CT
- Full-time
- 18 years or older
- Medicine
- 7 years
(Senior) Patient Safety Physician, Medical Safety Physician - CRM
BI Pharmaceuticals, Inc. —Ridgefield, CT
- $280,000 - $394,000 a year
- Full-time
- Medicine
- BC/BE
- Research
Lead Patient Safety Physician - CRM
BI Pharmaceuticals, Inc. —Ridgefield, CT
- Full-time
- Medicine
- BC/BE
- Senior level
AD / Senior AD, Clinical Pharmacology Lead - Remote
BI Pharmaceuticals, Inc. —Ridgefield, CT
- $140,000 - $269,000 a year
- Full-time
- 18 years or older
- Medicine
- Pass drug screening
(Senior) Patient Safety Physician, Medical Safety Physician - Oncology
BI Pharmaceuticals, Inc. —Ridgefield, CT
- $280,000 - $394,000 a year
- Full-time
- Medicine
- BC/BE
- Research
Director, Regulatory Affairs – CMC
Rocket Pharmaceuticals —United States
- $204,000 - $264,000 a year
- Full-time
- Bachelor of Science
- 8 years
- Bachelor's degree
- Paid holidays
- Health insurance
Senior Medical Science Liaison (Nephrology) - Lower Manhattan, Brooklyn, Staten Island, Long Island
Vertex Pharmaceuticals —United States
- $171,300 - $256,900 a year
- Full-time
- English
- Mentoring
- Data entry
- Loan repayment program
- Health insurance

Discover related jobs

Based on your search for regulatory affairs jobs.

Staff Specialist, Regulatory Affairs
Stryker —Mahwah, NJ
Preferred to be in Engineering, Science, or a related field. Depending on customer requirements employees and new hires in sales and field roles that require…
$114,800 - $191,400 a year
Regulatory Affairs Manager
BIOWAVE CORPORATION —Westport, CT
Experience working within ISO 13485-regulated environments and with technical documentation, design controls, risk management, change assessment, and post-…
$100,000 - $110,000 a year
Quick Apply

Show more related jobs

Explore jobs in cities nearby

Check out jobs in cities near your current location, Columbus

Packaging Compliance Manager/Packaging Engineer in Regulatory Affairs - Columbus OH/Abbott Park, IL (internal OUS can apply)
Abbott Laboratories —Columbus, OH
Evaluate various technical alternatives and perform risk assessment and analysis. Bachelor's degree (or equivalent) is required - preferred area of focus in…
$99,300 - $198,700 a year
Manager, Regulatory Affairs
Victoria's Secret —Reynoldsburg, OH
Experience improving processes, implementing tools, or driving operational efficiencies. Bachelor’s degree in a relevant field.
$112,700 - $153,720 a year

Show more jobs in cities nearby

I want to receive the latest job alert for regulatory affairs in fishkill, ny

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory affairs jobs near fishkill, ny

Senior Associate Director jobs in San Francisco, CA

Senior Associate Director jobs in Boston, MA

Food Beverage Director jobs in Dallas, TX

Athletic Director jobs in Oklahoma

Senior Associate Director jobs in Denver, CO

Senior Associate Director jobs in Washington, DC

Director Of Regulatory Affairs jobs in San Francisco Bay Area, CA

Director Of Regulatory Affairs jobs in Hayward, CA

Director Of Regulatory Affairs jobs in Durham, NC

Regulatory Attorney jobs in Washington, DC

Director Of Regulatory Affairs jobs in Oklahoma City, OK

Senior Associate Director jobs in Cedar Rapids, IA

Senior Associate Director jobs in Fort Lauderdale, FL

Senior Community Care Of Kentucky Pace jobs in Louisville, KY

Senior Associate Director jobs in Remote

Director Of Guidance jobs in Massachusetts

Senior Associate Director jobs in Notre Dame, IN

Jobs For Senior Citizens jobs in Mooresville, NC

New Perspective Senior Living jobs in Franklin, WI

Patient Safety Technician jobs in Newton, NJ

Senior Associate Director, Medical Affairs Strategy Team Member - Pulmonary ILD (Hybrid)

BI Pharmaceuticals, Inc. -
Ridgefield, CT

Apply Now

Job Details

Full-time

Qualifications

Optimizing workflow processes
Pharmaceutical company experience
Data analytics
Managing projects
Risk assessment
Process improvement planning
Cross-functional collaboration
Cross-functional communication

Full Job Description

As an employee of Boehringer Ingelheim, you will actively contribute to the discovery, development, and delivery of our products to our patients and customers. Our global presence provides opportunity for all employees to collaborate internationally, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in several ways to foster a healthy working environment, meaningful work, mobility, networking, and work-life balance. Our competitive compensation and benefit programs reflect Boehringer Ingelheim's high regard for our employees.

The Senior Associate Director, Medical Affairs Strategy Team Member serves as the subject matter expert to create the indication-specific or product-specific Medical strategic framework and prioritized Medical tactics to ensure the success of the respective BI product(s) from a Medical Affairs perspective, both prior to and leading up to launch as well as throughout the product lifecycle. This individual will bring together strong technical knowledge of the therapeutic area, strong command of the relevant clinical practice guidelines and related scientific data as well as the understanding of the overall TA priorities and value drivers into an integrated strategic medical plan and tactics that enable the successful medical affairs contribution to BI’s portfolio and informs clinical development efforts where applicable. The incumbent will work with relevant stakeholders to drive integrated medical plans and executable tactics customized for organized customer channels including Health Systems and Payers.

The Senior Associate Director, Medical Affairs Strategy Team Member collaborates cross functionally within the larger Clinical Development & Medical Affairs (CDMA) department (e.g., Medicine Excellence, Field Medical Affairs, RWE, etc.) and across the organization (e.g., Marketing, Market Access, Analytics & Insights (A&I), HEOR, Clinical Operations, Patient Services, Legal, Compliance, etc.) and with global counterparts to create, execute, measure and adapt the Medical Affairs strategy to best fit the needs of the US clinical landscape and market dynamics of relevance to the respective TA.

Duties & Responsibilities

Works with the US TA, RWE, FBM, Medical Excellence, and the global TA teams to co-design and implement launch planning strategies as well as the generation of an integrated evidence plan for pulmonary fibrosis products/indications that prioritize innovation and address meaningful gaps internally and externally.
Effectively executes medical tactics within allocated budgets, lead key data release activities, stay abreast of paradigm shifts in clinical practice, and align with BI / CDMA objectives, clinical development pipeline and the evolving US healthcare landscape.
Works with the Medical Strategy Team Leader, the US TAs, global medical, Commercial operations, Go-To-Market (GTM), and CDMA leaders to identify and leverage synergies throughout the product lifecycle and actively provide input into clinical development early asset planning, Commercial strategies to ensure the success of launches and timely execution of prioritized evidence generation initiatives.
Collaborates very closely with the respective Clinical Development counterparts to ensure integration of US medical affairs strategic insights and market dynamics into the appropriate clinical development governance processes and decisions.
Serves as a key driver for pulmonary fibrosis products to maximize business opportunities from a medical perspective, identify risks, assess the competitive landscape, and ensure appropriate collaboration occur with various business functions.
Partners with stakeholders to ensure the integration of insights, as well as planning and executing the agreed tactics while maximizing the medical communication channels and Strategic Engagement program with key experts, scientific leaders, and key institutions.
Actively contributes to strategic congress planning, medical education programs, advisory boards, publication strategies, scientific advancement grants, interface with professional societies relevant to the pulmonary fibrosis products.
In collaboration with Medical Customer Experience, A&I, and Capability Excellence teams ensures the effectiveness of the respective medical affairs budget and planning activities to strengthen digital, hybrid and omnichannel growth opportunities.
Actively contributes at and represents the CDMA TA team in internal business planning workshops and relevant strategic planning governance regarding pulmonary fibrosis products to ensure effective co-creation of appropriate, aligned, and integrated critical success factors, strategic imperatives, and their associated outcome measures (e.g., key performance indicators, metrics).
Leads proactive and ad hoc TA specific US projects to drive key strategic initiatives that facilitate business agility, customer focus and ensure compliance standards are met.
Leverages CDMA resources to create tailored tools and material to address organized customers, Payers/Systems in support of the Account Medical Advisors (AMA's).
Co-creates an aligned strategic framework for organized customers in collaboration with the Value/Access and Health-Systems marketing teams.
Ensures coordinated communication plan for Payers/Systems across the relevant internal stakeholders with emphasis on leading the medical affairs aspects of these plans.

Requirements

Bachelor’s degree required, and in addition fulfill one of the following education levels:
- Advanced degree (PharmD, NP, PA, Master’s, M.D., DO, Ph.D.)
- Combined BSc. with a MBA, or BSN with an MBA
- Other medically qualified licensure (e.g., RPh, Respiratory Therapist)
Seven (7) years of professional experience in a scientific, clinical, and/or medical space, including five (5) years in relevant position in pharmaceutical or related industry.
One-plus (1+) years of experience in Medical Affairs, Clinical Trials, Regulatory, or related area supporting relevant Therapeutic area.
Demonstrated experience with pharmaceutical drug development and the use of data analysis for strategy development, business process improvement, product launch planning, and integrated evidence generation required.
Ability to collaborate, influence, and establish strategic direction as well as drive effective execution.
Ability to translate scientific and medical market insights into medical tactical plans for effective launches of pharmaceutical products in the US, integrated evidence generation plans, and optimized medical strategies.
Demonstrated ability to collaborate cross-functionally to enable successful execution and deliver results in a deadline-driven environment while managing multiple priorities.
Strong understanding of Pulmonary ILD therapeutic area(s), shifting US healthcare environment, medical, pharmaceutical and payor market dynamics, portfolio growth, and ability to manage multiple projects and identify risks in a fast-paced environment with a drive for results and sense of urgency to meet medical market needs.

Eligibility Requirements :

Must be legally authorized to work in the United States without restriction.
Must be willing to take a drug test and post-offer physical (if required).
Must be 18 years of age or older.

Compensation

Apply Now

Refine Your Search

regulatory affairs jobs in fishkill, ny

Senior Associate Director, Medical Affairs Strategy Team Member - Pulmonary ILD (Hybrid)

Senior Associate Director, Medical Affairs Strategy Team Member - Respiratory (Hybrid)

(Senior) Patient Safety Physician, Medical Safety Physician - CRM

Lead Patient Safety Physician - CRM

AD / Senior AD, Clinical Pharmacology Lead - Remote

(Senior) Patient Safety Physician, Medical Safety Physician - Oncology

Director, Regulatory Affairs – CMC

Senior Medical Science Liaison (Nephrology) - Lower Manhattan, Brooklyn, Staten Island, Long Island

Discover related jobs

Explore jobs in cities nearby

I want to receive the latest job alert for regulatory affairs in fishkill, ny

Explore jobs in more locations

Duties & Responsibilities

Requirements

Compensation

Job Seeker Tools

Employer Tools

Browse

Stay Connected