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Industry: Internet News
Company Size: 11-50 employees

BioSpace

Savvy Admin PROD

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

We have an opening in our Monmouth Junction, NJ facility for an experienced Specialist, Regulatory Affairs Advertising & Promotion Review to join our Regulatory Affairs team.

The incumbent will partner closely with the Head of Regulatory Affairs Advertising & Promotion to perform regulatory review in support of advertising and promotional activities across the business and cross-functional teams and to ensure compliance with regulatory requirements while driving strategic promotional initiatives. She/he leverages extensive pharmaceutical and regulatory experience to manage complex projects, provides expert guidance and contributes to continuous improvement of regulatory affairs advertising and promotion review processes.

**Essential Functions**

- Leads regulatory reviews of external communications intended for healthcare professionals (HCPs), patients and caregivers, ensuring high-quality, accurate and compliant content aligned with US laws, Food and Drug Administration (FDA) regulations and guidance, Pharmaceutical Research and Manufacturers of America (PhRMA) principles and company policies

- Provides authoritative regulatory advice on promotional content, evaluate promotional claims, and develops compliant strategies in collaboration with Commercial, Medical and other relevant teams

- Ensures product promotion materials are consistent with FDA-approved labeling and effectively manage related submission processes

- Oversees timely and accurate submissions of promotional materials using FDA Form 2253

- Establishes, enhances and streamlines regulatory review processes, promoting best practices and operational excellence

- Acts as a regulatory subject-matter expert in cross-functional meetings, ensuring alignment on regulatory requirements and business goals

**Requirements**

REQUIREMENTS

- Bachelors degree in a life-science field (advanced degree preferred) and minimum 2 years pharmaceutical or biotechnology industry experience reviewing promotional and non-promotional materials and submissions using the 2253 form to the FDA REQUIRED

- In-depth knowledge of FDA regulations, US promotional laws and industry best practices REQUIRED

- Proven ability to analyze complex medical and scientific information and apply regulatory principles REQUIRED

- Proficiency with regulatory submission tools REQUIRED

Work Arrangements: We are a HYBRID work environment requiring candidates to work majority of every week in our NJ office.

Anticipated salary range: $100 to $140K/yr. Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

Tris Pharma, Inc. offers a highly competitive compensation and benefits package. To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

Specialist, Regulatory Affairs Advertising & Promotion Review

Tris Pharma, Inc. (www.trispharma.com) is a leading privately-owned U.S. biopharmaceutical company with a focus on development and commercialization of innovative medicines in ADHD, spectrum disorders, anxiety, pain and addiction addressing unmet patient needs. We have >150 US and International patents and market several branded ADHD products in the U.S. We also license our products in the US and ex-US markets. We have a robust pipeline of innovative products spanning neuroscience and other therapeutic categories employing our proprietary science and technology.

Our science and technology make us unique, but our team members set us apart; they are the engine fueling Tris’ passion and innovation. Our colleagues understand the criticality of operating a successful business and take pride in the company’s success. Equally importance to each team member is how we interact with one another on a daily basis. We believe in each other and in respectful, open and honest communications to help support individual and team success.

Our Product Development laboratory, located in our Monmouth Junction, NJ headquarters is growing, and has positions open for an experienced PD Scientist. Title and salary commensurate with experience. (See below)

**Summary**

The Product Development (PD) Senior Scientist, under minimal guidance, designs, plans and conducts pre-formulation, formulation and process development activities as well as scale-up trials of complex projects using risk-based approach. The incumbent plans, coordinates and executes current Good Manufacturing Practices (cGMPs) pilot and pivotal/submission batches, including all required documentation. She/he prepares technical and product development reports and regulatory submission document and performs critical analysis.

The incumbent collaborates closely with other functions within and outside Research and Development (R&D) to ensure project timelines are met. She/he also trains new employees and mentors lower level scientists, as appropriate.

**Essential Functions**

Primary duties/responsibilities

- Carries out responsibilities in accordance with the organization’s policies, Standard Operating Procedures (SOPs), and state, federal and local laws

- Designs, plans and conducts product development activities, including pre-formulation, formulation, process development and scale up studies of complex projects to ensure good scientific standards are met

- Documents all study details and results in laboratory notebooks and batch records compliant with current Good Documentation Practices (cGDP) and cGMP; Summarizes data, discusses results and makes conclusions in technical reports; Meets project deadlines and performance standards, as assigned

- Creates invention disclosures; Collaborates with internal and external counsel to perform patent landscape analysis, draft patent applications, and respond to office actions

- Utilizes risk-based approaches and Quality by Design (QbD) principles in guiding pharmaceutical development and identifying critical quality attributes (CQA), critical material attributes (CMA), critical process parameters (CPP) and control strategies. Uses problem solving tools to trouble shoot, as needed

- Designs and conducts physical and chemical characterization in liaison with analytical teams

- Performs critical data analysis using statistical tools including stability analysis

- Plans, coordinates and manufactures cGMP pilot and pivotal batches, including drafting of protocols, master batch records and reports

- Liaises, coordinates and manages PD activities with external labs, Clinical Research Organizations (CROs) and Clinical Development Manufacturing Organizations (CDMOs), including cGMP manufacturing activities; Collaborates closely with other functions within and outside R&D to ensure project timelines are met

- Presents and updates project status and issues/challenges to management

- Supports technical services and operations to trouble-shoot scale up and commercial processes

- Collaborates with, and assists, Regulatory Affairs with coordination and submission of pivotal batches to CROs

- Ensures cleanliness and functioning of PD areas and proper maintenance of equipment and instruments; Supports review of qualification documents for process equipment

- Authors regulatory submission documents for New Drug Application (NDA)/Abbreviated New Drug Application (ANDA), supplements, annual reports and Investigator Responses (IR)/Complete Response Letters (CRLs), covering pharmaceutical development and manufacture, including product development reports

- Creates and revises PD Standard Operating Procedures (SOPs), as needed

- Collaborates with Quality Assurance (QA) department on investigations, Corrective Action Preventive Action (CAPAs) and changes controls, as needed; Supports Technical Services and Operations departments to troubleshoot scale up and commercial processes

- Participates in training of new employees and mentors lower level scientists

**Requirements**

Requirements

**Knowledge/Skills/Abilities Required**

Minimum education and years of relevant work experience

**PD Scientist III**

Bachelors degree in Pharmaceutical Science or related scientific field and minimum 8 years experience in pharmaceutical formulation and product development OR Masters degree in Pharmaceutical Science or related scientific field and minimum 5 years experience in pharmaceutical formulation and product development OR PhD in Pharmaceutical Science or related scientific field and minimum 0-3 years experience in pharmaceutical formulation and product development.

**PD Senior Scientist I**

Bachelors degree in Pharmaceutical Science or related scientific field and minimum 10 years experience in pharmaceutical formulation and product development OR

Masters degree in Pharmaceutical Science or related scientific field and minimum 8 years experience in pharmaceutical formulation and product development. OR

PhD in Pharmaceutical Science or related scientific field and minimum 3 years experience in pharmaceutical formulation and product development

Special knowledge or skills needed and/or licenses or certificates required

- In depth experience designing and conducting oral controlled release solids and liquids pharmaceutical formulation and process development studies with high scientific standard of multiple dosage forms

- Working knowledge of QbD and risk-based approaches

- Working knowledge of Food and Drug Administration (FDA), cGMPs, Drug Enforcement Administration (DEA), Occupational Safety and Health Administration (OSHA), SOPs and regulatory rules, regulations and guidelines

- Strong technical writing skills and experience (i.e., SOPs, investigations, protocols, reports, submission documents, etc.)

- Proficiency with Microsoft Office

- Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members

- Analytical thinking with problem-solving skills and the ability to adapt to changing priorities and deadlines

- Planning, organization and time management skills including the ability to support and prioritize multiple projects

- Fluent in English (verbal and written)

- Ability to distinguish colors

Anticipated salary range PD Scientist III: $95k-120k/year

Anticipated salary range PD Senior Scientist I: $115k-130k/yr.

Base salary offered is contingent on assessment of candidate’s education and experience level relative to requirements of the position and a review of related industry standards and internal equity.

Additional benefits: In addition to base salary, full-time employees are also eligible for incentives, including, but not limited to: bonus eligible, medical, dental, vision, Rx insurance, 401K with match, life insurance, paid Company Holidays, PTO, Paid Volunteer Time and Employee Resource Groups.

To build and enhance our diverse workforce, we encourage applications from individuals with disabilities, minorities, veterans, women, LGBTQ, etc. Tris Pharma, Inc. is an Equal Opportunity Employer.

PD Scientist III/Senior Scientist I

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Since 2008, our mobile fitness training company has continued to grow, helping thousands of clients improve their fitness and their lives, no matter their age or ability.

Industry: Wellness and Fitness Services
Company Size: 501-1,000 employees

GYMGUYZ

Responsive recruiter

**Benefits**

- Competitive salary

- Flexible schedule

- Opportunity for advancement

- Free uniforms

**Position Overview**

We are seeking a passionate and motivated **Female Exercise Specialist ** to join our dynamic team. As a Female Exercise Specialist at GYMGUYZ, you will provide personalized fitness training to clients in the comfort of their own homes. Your goal will be to inspire, motivate, and empower clients to achieve their fitness objectives through tailored workout plans and a supportive coaching style.

**Why Join GYMGUYZ?**

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- Receive comprehensive training, including:

- Reduced-cost recertifications

- Paid GYMGUYZ training

- A mentorship program

- Advance your career with opportunities for increases and promotions such as:

- Master Personal Trainer

- Personal Training Manager

- General manager

**Compensation Structure (paid Bi-weekly)**

- Above-average hourly compensation

- Commission

- Renewal bonus

- Client referral bonus

- Employee referral incentive

**Responsibilities**

- Conduct one-on-one fitness training sessions with clients in their homes or other designated locations.

- Develop customized exercise programs based on clients’ fitness levels, goals, and preferences.

- Provide ongoing support, motivation, and accountability to clients throughout their fitness journey.

- Monitor client progress and adjust training plans as needed to ensure continued success.

- Educate clients on proper exercise techniques and the importance of a balanced lifestyle.

- Foster a positive and encouraging training environment that promotes client engagement and satisfaction.

- Maintain professional and effective communication with clients and the GYMGUYZ team.

**Qualifications**

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- 1-2 years of experience in personal training or group fitness is preferred but not required.

- Genuine passion for helping clients reach their fitness goals.

- Strong knowledge of exercise techniques, anatomy, and nutrition.

- Excellent communication and interpersonal skills.

- Ability to motivate and inspire clients.

- Reliable transportation and a valid driver’s license.

- Flexible schedule, including availability for evenings and weekends.

- Background in Physical Therapy is a plus.

- Experience with special needs is a plus.

**Company Overview**

At GYMGUYZ, our team members provide convenient, customized, and creative workouts in the location of our clients' choosing. As the largest in-home and on-site personal training provider in [LOCATION], we are driven by our core values—Determination, Respect, Integrity, Versatility, and Excellence (D.R.I.V.E.)—which guide everything we do.

Our success is built on our four pillars: Fun, Unity, Earnings, and Leadership (F.U.E.L.), creating a dynamic and supportive environment for both our clients and team members.

Compensation: $30.00 - $50.00 per hour

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.

~~This franchise is independently owned and operated by a franchisee. Your application will go directly to the franchisee, and all hiring decisions will be made by the management of this franchisee. All inquiries about employment at this franchisee should be made directly to the franchise location, and not to GYMGUYZ Corporate. ~~

Female Exercise Specialist

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