Associate Director / Director, Medical Writing Job at Beam Therapeutics (Cambridge)

Associate Director, Investigations

The Associate Director, Investigations provides senior leadership and advanced s...

Location

United States , Alpharetta

Salary:

154000.00 - 180000.00 USD / Year

Avanos

Expiration Date

Until further notice

Requirements

Bachelor’s degree or its non-U.S. equivalent – required
Advanced degree, including MBA, JD, or equivalent - required
7+ years of experience at a medical device, pharmaceutical, or other healthcare organization implementing a compliance program or other complementary job experience (such as roles within Internal Audit, Finance or Legal functions)
Expertise in Marketing or other fields will be considered upon demonstration of skill sets needed to perform the job duties
Experience in Healthcare industry – Device, Pharma, or Biotech is preferable
English language fluency required
Valued Advisor to business leaders with experience finding solutions to complex ethical issues
Excellent research, writing, and communication skills, and excellent ability to analyze complex matters and present them simply and clearly
Excellent organizational and time management skills with the ability to prioritize and manage a heavy and multi-directional workload
Demonstrates Integrity and commitment to the highest ethical standards and personal values

Job Responsibility

Oversight: Supports the implementation of the Global Compliance Program under the direction of the Chief Ethics & Compliance Officer
Risk Assessment Activities: Supports the annual Risk Assessment and reviews activity-specific plans by the business teams
Third Party Management: Leads the Third Party Seller and Non-seller Third Party (NSTP) compliance management and initiatives
Investigations: Leads the investigations into Ethics & Compliance related issues, allegations, or identified areas of risk
Helpline: Owns the helpline vendor relationship and managements the system, data flows and communications with internal and external stakeholders
Corrective Actions: Implements and tracks appropriate and consistent corrective actions for identified compliance issues and assessment activities
Written Standards: Provides support on the drafting, implementation and communication of Compliance-related policies and procedures
Program Management: Implements actions as specified in the annual work plan and KPIs
Training and Communications: Supports the implementation of the annual training and education plans
Monitoring and Auditing: Supports the Audit, Monitoring and Investigations teams in activities as required

What we offer

benefits on day 1
free onsite gym
onsite cafeteria
HQ region voted 'best place to live' by USA Today
uncapped sales commissions
generous 401(k) employer match of 100% of each pretax dollar you contribute on the first 4% and 50% of the next 2% of pay contributed with immediate vesting
attractive incentive compensation program

Fulltime

Associate Director, Regulatory

This role will serve as the Regulatory Lead for our pivotal program leading to B...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Bachelor's degree in life sciences or related field required (advanced degree preferred)
Minimum of 5 years of experience in regulatory affairs for biopharmaceuticals or cell therapy (preferred)
Strong understanding of the drug development process from pre-clinical to commercialization, (prior BLA experience required)
Experience in reviewing and writing regulatory submission documents for global regulatory filings such as IND, CTAs, and BLAs/MAAs and related health authority interactions
Knowledge of GXPs and key requirements for clinical, nonclinical and CMC documentation for regulatory submissions in ICH regions
Excellent communication, negotiation, and leadership skills
Strong team orientation and passion for continuous self-development

Job Responsibility

Regulatory Strategy Development: Manage all regulatory aspects of Cabaletta’s lead program through pivotal clinical studies and BLA/MAA approval, including the preparation of clinical trial applications, amendments, correspondence, applications for expedited programs, health authority meetings, marketing applications, and labeling and promotional reviews for regulatory agencies, including FDA, Health Canada, EMA, MHRA and other countries, as applicable
Collaborate with cross-functional teams including clinical and nonclinical development, manufacturing, quality assurance, and medical affairs to develop and implement competitive regulatory strategies that expedite development and maximize the probability of success for cell therapy product development
Stay informed about evolving regulations and guidelines related to cell therapy and adapt strategies accordingly
Assess and communicate potential regulatory risks and propose mitigation plans
Regulatory Submissions and Compliance: Prepare and oversee the submission of regulatory documents, including INDs, CTAs, BLAs/MAAs, and other relevant submissions to regulatory agencies (e.g., FDA, EMA)
Ensure the quality and accuracy of regulatory submissions, adhering to timelines and requirements
Ensure compliance of programs and submission documentation with current regulations and guidelines governing cell therapy products
Regulatory Interactions: Represent the company during interactions with regulatory agencies, including meetings, teleconferences, and written communication
Prepare meeting requests, briefing documents, and coordinate and prepare teams for meetings with health authorities
Coordinate and prepare responses to requests for information from regulatory agencies

What we offer

health and retirement, PTO, and stock option plans

Associate Scientific Director

Fingerpaint Group’s medical communications solutions, Fingerpaint Medical, help ...

Location

United States

Salary:

Not provided

Fingerpaint Group

Expiration Date

Until further notice

Requirements

PhD in life sciences or PharmD
≥ 3 years professional medical writing experience in a scientific communications agency

Job Responsibility

Independent and accurate medical writing on a variety of medical communication projects which execute on the medical strategy
Provide strategic writing support for publication and medical communication plans
Attend scientific/client meetings and provide pre- and post-meeting materials as needed
Verbal and written internal communication (eg, project status) and external communication (eg, clients and authors)
Mentor junior staff, providing content review
Participate in providing project support input such as scheduling and prioritizing tasks
Contribute to defining solutions to client challenges and facilitate organic growth in accounts
Contribute to new business development as needed
Willingness to travel (~15%)

Paramedic

You have a purpose, unique talents and NOW is the time to embrace it, live it an...

Location

United States , Breckenridge

Salary:

23.43 - 35.61 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Three years of experience as a Paramedic in an Emergency Department and/or emergency pre-hospital setting
Demonstrated ability to function in a team environment
Strong communication skills
Ability to read, write, speak, and understand English
Basic computer skills
High School diploma or GED required within one year of hire
Graduation from an accredited Paramedic Training Program, recognized by Colorado Department of Public Health and Environment (CDPHE)
Current registered Paramedic with the State of Colorado Department of Public Health and Environment (CDPHE)
Advanced Cardiac Life Support
BLS from the American Heart Association required

Job Responsibility

Provides safe and effective care for patient(s) within the scope of practice, in accordance with physician’s orders, established standards and administrative policies, as part of the health care team
Functions under the direction of the hospital based Medical Director, who will be the Paramedic Medical Director
Follows the Medical Director's determined scope of practice for the Paramedic within the Acts Allowed specified by the Colorado Department of Public Health and Environment
Be on a health care team that decides the patient care interventions
Provides quality of care and service to meet the healthcare needs of patients and their families

What we offer

medical
prescription drug
dental
vision plans
life insurance
paid time off
tuition reimbursement
retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Parttime

Associate Director Medical Writer

The Associate Director Medical Writer is an individual expert who can manage and...

Location

Canada , Mississauga

Salary:

Not provided

GSK

Expiration Date

Until further notice

Requirements

PhD or relevant working experience within the life sciences space
Proven track record in writing clinical/regulatory documents including, but not limited to: protocols, clinical study reports, NDA/MAA CTD submission documents, investigator brochures, briefing documents, and responses to regulatory authority questions
Work in a matrix team to ensure delivery of high quality, fit-for-purpose clinical documents that accurately reflect associated data, and are in line with GSK standards and global, regional and/or local regulatory requirements
Experienced as a significant contributor in planning and production of clinical dossier documents for regulatory submissions worldwide
Demonstrated effectiveness in management of projects of increasing scope and complexity
Understanding of the interdependencies of various contributing functions (e.g., clinical pharmacology, biomarkers, health outcome)
Ability to quickly assess complex situations, apply scientific, operational, and submission development knowledge and implement effective plans for solutions
High-level computer skills and general computer literacy
Demonstrated knowledge of scientific methodology and statistical principles in the design, conduct and description of clinical research
Ability to interpret clinical data, assess trends and patterns in text and statistical data, and effectively organize content and messages in clinical reports and summary documents

Job Responsibility

Contribute to the planning, authoring, review, and approval of clinical/regulatory documents for medical writing project to achieve a successful outcome within the required timelines
Possess highly effective communication skills and is capable of presenting ideas and data clearly to a group, including key stakeholders at a senior level
Provide major input to submission teams in development of submission plans, timelines, document content and dependencies
Advises on or recommends methods for achieving accelerated timelines, including review tools and automation
Actively contribute to development of training materials for clinical document preparation
provides mentoring and/or training on clinical documentation and submission planning to individuals or teams
Champion change and contributes to departmental or cross-functional process improvement initiatives and develops/revises standards for GSK submission documents
Effectively contribute to process improvement activities

What we offer

Competitive base salary
Annual bonus based on company performance
Flexible working options available for most roles
Learning and career development
Access to healthcare & wellbeing programmes
Employee recognition programmes

Fulltime

Associate Director, Medical Affairs (Scientific Communications/Publications)

We are seeking a detail-oriented and proactive Associate Director, Medical Affai...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Master’s degree in Health Care, Life Sciences, Biomedical Sciences, or a related field
>3 years of experience in medical affairs, scientific communications, or publication planning within the biotechnology or pharmaceutical industry
Therapy area experience in rheumatology, neurology, immunology, and/or cell therapy
Experience working with publications management software/vendors (such as iEnvision, PubStrat, PubPro)
Experience managing a publications or asset/project budget including overseeing external vendors
Strong scientific writing skills with the ability to translate complex scientific data into clear and concise publications, including ability to analyze and interpret clinical trial data
Knowledge of publication guidelines (e.g., ICMJE, GPP2022) and industry best practices
Excellent organizational skills with the ability to manage multiple projects simultaneously and meet deadlines
Proficiency in Microsoft 365 (Word, Excel, PowerPoint, OneNote)
Ability to travel up to 25% to attend conferences and meetings

Job Responsibility

Manage the end-to-end process of publication planning, ensuring adherence to timelines and compliance with industry standards
Collaborate with cross-functional teams, including Clinical Development, Translational Medicine, Computational Biology, Regulatory Affairs, and external authors/key opinion leaders, and vendors, to facilitate the development of manuscripts, abstracts, posters, and presentations
Manage the operational execution and day-to-day budget for external medical writing and communications agencies that support content and publication deliverables
Lead the preparation of journal manuscripts and abstracts and presentations for medical conferences, ensuring compliance with conference guidelines and requirements
Advise teams regarding compliance with medical publications as defined in journal and congress guidelines
Coordinate internal review processes and facilitate approval workflows for publications in collaboration with Legal, Compliance, and Medical teams
Train internal teams on publications software and workflows
Assist in the preparation of scientific content for medical conferences and other scientific forums
Maintain awareness of industry trends and regulatory guidelines related to publication practices in the biopharmaceutical industry
Develop and execute comprehensive scientific engagement strategies and congress plans (i.e. manage relationships with conference organizers, lead internal pre/post congress meetings, organize onsite HCP meetings, etc.)

What we offer

health and retirement
PTO
stock option plans

Annual Giving Associate Director

The Associate Director, Annual Giving is a member of the Annual Giving Direct Re...

Location

United States of America , Rochester

Salary:

60431.00 - 84603.00 USD / Year

University of Rochester

Expiration Date

Until further notice

Requirements

Bachelor’s Degree Required
A minimum of 5 years of relevant or related experience, Required
or equivalent combination of education and experience Required
Proficiency with Microsoft Office suite, particularly Excel, or willingness to train and practice extensively. Required
Comfort level with relational constituent databases, project management, and analytical skills to review and assess complex information. Required
Ability to solve problems and manage fundraising activities effectively. Required
Attentive to detail, excellent communication and writing skills, and the ability to work within a complex organization, exercising tact in communicating to senior fundraising professionals and campus partners including division administrators, chiefs, and department chairs
discretion in handling high-risk data (PII and PHI). Required

Job Responsibility

Strategy direction: Create and implement long and short-term strategies for assigned unit campaigns as a part of overall Annual Giving Program plan for the fiscal year
Work closely and directly with assigned unit staff, department heads and directors to coordinate a year-long plan of solicitations, communications and timelines
Build and maintain positive relationships with internal and external partners, unit staff, physicians, PR and marketing staff, designers, and vendors
Develop and oversee mail, email and digital campaigns for assigned units
Use analytics to guide campaigns and budget allocation for each project
Collaborate with and monitor external mail house vendors on executing mailings
Conduct benchmarking research to refine messaging and solicitation strategies
Analyze program results throughout the year and recommend changes to achieve goals
Present quarterly reports throughout the fiscal year to unit contacts and Advancement principals
Review and refine reporting mechanisms to maximize analysis of annual giving efforts

Fulltime

Risk Adjustment Education Specialist

This Job will report to the Risk Adjustment Manager of Coding Operations. Respon...

Location

United States , Irving

Salary:

Not provided

CHRISTUS Health

Expiration Date

Until further notice

Requirements

Associate degree or equivalent experience required
5 years of experience in a hospital, a physician setting, or a Managed Care Organization as a medical coder required
2 years of experience in coding with knowledge of Medicare risk adjustment (HCC Coding) required
Other experience in teaching, training, or an educator/instructor role is needed
Must have experience in creating effective training materials and presentations (PowerPoint, Adobe, etc.)
Certified Professional Coder (CPC) from AAPC is required
Certified Risk Adjustment Coder (CRC) from AAPC is preferred
An RN or LVN must obtain both CPC and CRC within 12 months of hire
Must be proficient in Prospective, Retrospective, and Concurrent review processes
Must have strong clinical knowledge of disease pathology and ability to identify clinical indicators related to chronic disease

Job Responsibility

Meets expectations of the applicable OneCHRISTUS Competencies: Leader of Self, Leader of Others, or Leader of Leaders
Subject matter experts for proper risk adjustment coding and CMS data validation
Work in conjunction with other departments, including Provider Relations, Quality, and the Medical Director, to ensure compliance with CMS risk adjustment guidelines
Analyze MRA data to identify patterns and development of provider and market-level interventions to coordinate an educational work plan for providers
Conduct provider education and training regarding risk adjustment to help ensure accurate CMS payment and improve care quality
This includes training venues such as provider offices, hospitals, webinars, conference calls, email correspondence, etc
Responsible for building positive relationships with assigned Physicians and serving as a contact for any questions or concerns that may arise
Identify those Practices that need initial or ongoing additional training
Perform other duties as necessary

Fulltime

Associate Director / Director, Medical Writing

Beam Therapeutics

Location:
United States , Cambridge

Category:
Research and Development

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
December 24, 2025

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