Current jobs related to Senior Manager, US Medical Ad/Promo Regulatory Review - Lexington MA United States - Velocity Resource Group
-
Boston, MA, United States EPM Scientific - Phaidon International Full timeTitle: Senior Director of Regulatory Affairs Ad/Promo Summary: A global biopharmaceutical company, dedicated to pursing novel therapeutics to aid those with chronic illnesses is looking to grow their Regulatory Affairs team and bring on a Senior Director of Regulatory Affairs Ad/Promo to join their team! The team is growing rapidly as they have had great...
-
Senior Director, Regulatory Affairs
3 weeks ago
Bedford, MA, United States Lantheus Full timeLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care with its broad product portfolio. Lantheus is an entrepreneurial, agile, growing organization that provides...
-
Boston, MA, United States National Black MBA Association Full timeThe Director, Advertising and Promotion Compliance, US will serve as the Regulatory Affairs (RA) representative for assigned products and therapeutic areas. They will be responsible for reviewing and approving the regulatory content of materials created for product promotion, disease awareness, and public affairs communications. The Director will also engage...
-
Boston, MA, United States Vertex Pharmaceuticals Incorporated Full timeJob Description Our Medical Writing function at Vertex is in-house, and our Writers are strategic partners in our drug development process, collaborating with cross functional teams to bring innovative new therapies to patients. This is a hybrid position which allows 2 days per week remote work and 3 days per week in our Boston Seaport office. General...
-
Director, Regulatory Affairs
3 weeks ago
Parsippany, NJ, United States Ferring Pharmaceuticals Inc. Full timeJob Description: As a privately-owned biopharmaceutical company, Ferring pioneers and delivers life-changing therapies that help people build families and live better lives. Our independence helps us cultivate an entrepreneurial spirit and long-term perspective that enables us to achieve growth and scale, while remaining agile and true to our 'people first'...
-
Brand Ambassador
4 weeks ago
Boston, MA, United States ATN Event Staffing Full timeBrand Ambassador – Promo Events at Holiday Pop Concert Job Description Role: Brand Ambassador Event: Promo Events at Pop Holiday Concert Overview:ATN Event Staffing is seeking energetic, experienced brand ambassadors to assist with promotional events at an annual holiday pop concert featuring top artists. As part of our team, you will assist with...
-
Senior/Executive Medical Director
4 weeks ago
Lexington, MA, United States Agenus Inc Full timeWe are a dedicated group of scientists, physicians, and businesspeople working together toward one goal: to discover and develop therapies that can unleash the power of the body’s immune system to treat and potentially cure cancer. We are passionate about the work we do every day at Agenus to deliver on the promise of immuno-oncology. If you’re looking...
-
Boston, MA, United States AstraZeneca Full timeDo you have expertise in, and passion for, Regulatory Affairs? Would you like to apply your expertise and channel the scientific capabilities in a company that follows the science and turns ideas into life-changing medicines? Then AstraZeneca might be the one for you! At AstraZeneca, we are using cell therapy to revolutionize the treatment of...
-
Senior/Executive Medical Director
3 weeks ago
Lexington, MA, United States RPMGlobal Full timeThe Role: The Medical Monitor is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. This position is expected to work independently across functional teams and lead/manage others to ensure the timely execution of the clinical development plan. The successful candidate will work...
-
Senior/Executive Medical Director
4 weeks ago
Lexington, MA, United States Agenus Full timeThe Role: The Medical Monitor is a key member of the clinical development team for the planning, conduct, analysis, and reporting of clinical studies. This position is expected to work independently across functional teams and lead/manage others to ensure the timely execution of the clinical development plan. The successful candidate will work independently...
-
Senior Medical Writer
3 weeks ago
Billerica, MA, United States Parexel International Corporation Full timePXL FSP is seeking to hire a Sr. Medical Writer! Job Purpose The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals. Key Accountabilities Leadership * Leads cross-functional teams to draft agreed-upon...
-
Senior Regulatory Affairs Consultant
4 weeks ago
Billerica, MA, United States Parexel International Corporation Full timeIf you are passionate about innovative therapies, love leading complex regulatory filings, and live for quality, on time, and within budget project deliverables, Parexel is E-X-P-A-N-D-I-N-G and we currently have openings for Senior Regulatory Affairs Consultants / Regulatory Affairs Leads. These are incredible opportunities to join a tight-knit team of...
-
Senior Scientist
2 months ago
Boston, MA, United States Takeda Pharmaceutical Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Senior Scientist
2 months ago
Boston, MA, United States Takeda Pharmaceutical Full timeBy clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...
-
Senior Manager, Compliance Advisory
4 weeks ago
McLean, VA, United States Capital One Full timeWest Creek 3 (12073), United States of America, Richmond, Virginia Senior Manager, Compliance Advisory - US Card Title: Senior Manager, Compliance Advisory - US Card Fraud & Merchant Disputes Level: Sr Manager Job Description: The Compliance Advisor Senior Manager performs a key risk management role (second line of defense), to help ensure corporate...
-
Regulatory Senior Engineer
3 weeks ago
, MI, United States PACCAR Inc Full timeRegulatory Senior Engineer Location: Farmington Hills, MI, US, 48331 Company: PACCAR Company Information PACCAR is a Fortune 500 company established in 1905. PACCAR Inc is recognized as a global leader in the commercial vehicle, financial, and customer service fields with internationally recognized brands such as Kenworth, Peterbilt, and DAF trucks....
-
Senior Manager, Regulatory Strategy
4 weeks ago
Los Angeles, CA, United States Identified Talent Solutions Full timeJob Title: Senior Manager, Regulatory Strategy Location: Azusa, CA Position Type: Full-time Exciting opportunity to join a dynamic and innovative Cosmetics company - the team is committed to excellence and continuous improvement in all aspects of the business, but most importantly QC/Regulatory. As the team expands operations, they seek a highly qualified...
-
Senior HR Director
4 weeks ago
Waltham, MA, United States Pharmaron Beijing Co. Ltd. Full timePharmaron, a leading R&D service provider in the life sciences industry, is seeking a dynamic and experienced Senior HR Director to oversee our HR efforts in the US. As a Director, lead a team of experienced HRBPs, while contributing to overall strategy and policy-making by advising the Management on human resource implications of its decisions. Key Roles...
-
Senior Regulatory Affairs Associate
4 weeks ago
BILLERICA, MA, United States Parexel International Corporation Full timeWe are seeking an experienced Regulatory Generalist to join our FSP team as a Senior Regulatory Affairs Associate / Regulatory Affairs Consultant to work closely with one large, dedicated client and provide operational support in the IND/NDA maintenance stage. The Sr. Associate / Consultant will also provide appropriate regulatory guidance to Project Teams...
-
Manager, Regulatory Affairs
3 weeks ago
Lakewood, CO, United States TERUMO BCT, INC Full timeManager, Regulatory Affairs Date: Sep 24, 2024 Location: Lakewood, CO, US Requisition ID: 32768 At Terumo Blood and Cell Technologies, our 7,000+ global associates are proud to come to work each day, knowing that what we do impacts the lives of patients around the world. For Terumo, for Everyone, Everywhere. We make medical devices and related...
Senior Manager, US Medical Ad/Promo Regulatory Review
2 months ago
Title: Senior Manager, US Medical Ad/Promo Regulatory Review
About the role:
Join Takeda as a Senior Manager, US Medical Ad/Promo Regulatory Review where you will serve as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. You will also provide regulatory strategic oversight for at least one complex product or therapeutic area/multiple products to help ensure regulatory compliance of promotional materials generated for assigned US products and compounds. You will support review of Patient Services and Corporate materials across different business units, including additional product responsibilities. As part of the US Medical team, you will report to the Director, Ad/Promo Regulatory Review. You will be based in either our Lexington, MA or Exton, PA home office. There may be an opportunity to consider remote candidates as well.
How you will contribute:
- Understand and interpret complex issues in relation to regulatory requirements and promotional strategy.
- Mentor and help develop staff. Assist with training and sharing technical and regulatory guidance to staff.
- Serve as the chair of promotional review meetings and assist Commercial with the planning and prioritization of proposed promotional and disease state materials.
- May present to senior management, and present regulatory topics to cross-functional teams.
- May serve as primary liaison with OPDP and APLB reviewers in the request and negotiation of advisory comments and any other interactions regarding use of promotional claims for assigned products.
- Ensure review standards within the electronic approval system (EAS) are upheld, and business needs are assessed and addressed.
- Support metrics to measure and track the effectiveness and efficiency of the promotional review process and provide recommendations for process improvements to address potential issues.
POSITION ACCOUNTABILITIES:
- Collaborate with colleagues in Regulatory Affairs, Medical, Legal, Commercial, and Compliance organizations and applies Regulatory knowledge to ensure promotional and non-promotional material development is accomplished following internal processes and standards.
- Be an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription drug and biologic products. Thoroughly review and assess proposed promotional items to evaluate their completeness, accuracy, and compliance with regulatory requirements.
- Understand broad concepts within Regulatory Affairs and potential effects across the organization. Identify regulatory issues. Offer creative solutions and strategies, including risk mitigation strategies.
- Evaluate regulatory risks and make recommendations relative to the promotional strategy.
- May provide management of individuals including mentoring, performance management, and staffing decisions. Mentor and develop staff. Identify and propose solutions to management for any resource gaps for brand responsibilities.
- Present to senior management and cross-functional teams regarding shared insights from FDA advisory comments, recent enforcement actions, and guidance documents.
- Collaborate with the International Regulatory Ad/Promo review teams for materials that are intended for global audiences (e.g., global press releases, new global campaigns).
- Other responsibilities as assigned.
What you bring to Takeda:
- Bachelor's Degree in life science or equivalent. Advanced degree (PharmD, PhD, MS, MBA, JD) preferred.
- You have a minimum of 4 years' experience in drug, biologic or device Regulatory Affairs or related field, including a minimum of 2 years' experience specific to Regulatory Affairs – Advertising and Promotion. Candidates with experience in related fields may also be considered.
- Knowledge of regulations and regulatory guidance specific to advertising and promotion of pharmaceutical/biologic products.
- Experience managing major regulatory filing(s) (e.g., launch advisory comment submission or responses to enforcement letters) preferred.
- Provide regulatory guidance to drug development teams, merging scientific principles and FDA law and regulations for development of marketing materials.
- Deal with issues of importance, provides regulatory advice and decision involving regulatory issues on topics for which there may not be clear/specific regulatory guidance.
- Understand the phases, processes and techniques used within a clinical development environment, and can contribute to clinical study design discussions.
- Maintain current knowledge of applicable government regulations, particularly those related to advertising and promotion, including important global codes of practice and regulations. Have knowledge of historical enforcement actions and can use this when offering recommendations to stakeholders.
- Excellent oral and written skills, timeline responsibilities, negotiations skills. Work well with others, especially on a cross-functional team, direct reports and senior leadership.
- Prior leadership of individuals/team not required, but preferred.
- Ability to effectively manage and bring working teams together for common objectives.
- Model leaders at all levels daily.
Licenses/Certifications:
- None required. Regulatory Affairs Certification (RAC) desirable.
Travel Requirements:
- Travel to meetings or client sites, including overnight trips. Some international travel may be required.
- Requires approximately up to 20% travel.
What Takeda can offer you:
- Comprehensive Healthcare: Medical, Dental, and Vision
- Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs and company match of charitable contributions
- Family Planning Support
- Flexible Work Paths
- Tuition reimbursement
More about us:
At Takeda, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we empower our people to realize their potential through life-changing work.
Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Absent an approved religious or medical reason, all US office-based and lab-based Takeda employees who work fully on-site or in a hybrid model (as determined by Takeda) must be fully vaccinated to work at a Takeda site or to engage with Takeda colleagues or anyone else on behalf of Takeda. US field-based employees must be fully vaccinated as a condition of employment, absent an approved religious or medical reason. US employees who work at a Takeda manufacturing facility, and those who work at a BioLife center or BioLife lab, may be subject to different guidelines. If you are contacted by a Takeda recruiter about your job application, we encourage you to seek more information on the applicable guidelines for the Business Unit/Function to which you have applied.
Empowering Our People to Shine
Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
