Director, Medical Writing Lead Job at Alfasigma (Milano)

Associate Director / Director, Medical Writing

Beam is seeking a highly talented and motivated AD/Director to join our growing ...

Location

United States , Cambridge

Salary:

180000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Bachelor’s degree required
MS, PharmD, or PhD preferred in a life science or health discipline
12+ years of clinical/regulatory medical writing experience in the pharmaceutical or biotech industry
A solid understanding of ICH guidelines, GxP, and relevant regulatory requirements
Demonstrated understanding of clinical regulatory documents (ie, protocol, IB, CSR, summaries for product filing, etc.) and experience as a lead author with such documents
Excellent communication skills, both oral and written
Ability to build strong relationships and work collaboratively across functions
Effective organizational and meeting skills and attention to detail
Experience with workflow management within standard document management systems
Ability to come onsite when needed such as for important meetings and team/company functions

Job Responsibility

Act as lead writer for clinical regulatory documents for the hematology program
Plan and lead the development of clinical study documents, working with cross-functional colleagues
Work closely with the regulatory team and other writers on regulatory document submissions
Assist with developing and maintaining medical writing process documents
Assist with evaluation and interpretation of the medical literature across several domains, such as study design, clinical development planning, statistical meaningfulness, and scientific rigor
Contribute to statistical output plans concerning organization and table layout for specific documents
Project management, strategic design, planning, team input, and reviews
Opportunities for management/mentorship of other writers

Fulltime

Medical Director, Global Evidence Generation Lead

The medical Director, evidence generation is responsible for supporting strategi...

Location

Belgium , Mechelen

Salary:

Not provided

Alfasigma

Expiration Date

Until further notice

Requirements

Minimum of 7+ years of experience in evidence generation, clinical development, HEOR, or a related field
At least 5 years of experience in Epidemiology, Health Economics Outcomes Research (HEOR), or/and Health Systems Research
Proven track record of developing and implementing integrated evidence generation plans in the pharmaceutical or biotechnology industry
Experience in design, conduct and oversight of real-world evidence studies ranging from protocol writing to project management oversight and data interpretation and communication
Solid understanding of the cross functional drug development lifecycle and processes (Business Development, clinical trial design, conduct, & endpoint selection, Clinical Operations, Data Management, Biostatistics, and Regulatory)
Demonstrated expertise and experience working with methods for evidence generation using primary and secondary data sources, knowledge of common issues and challenges of implementation, and track-record of successful publications
Demonstrated depth of understanding of observational research methods, regulatory standards, and ability to leverage epidemiologic and data science expertise to meet evolving business needs
Evidence of technical expertise of applying pharmacoepidemiology evidence and insights at the therapy/product level
Ability to explain strengths and limitations of clinical practice datasets — such as electronic health records, claims, clinical data registries, patient generated health data, and other health data sources — in context of designing pharmacoepidemiology study designs
Ability to work successfully in a matrix and quick paced environment

Job Responsibility

Collaborate with cross-functional colleagues to Lead the development and execution of Medical evidence generation strategy and tactics supporting products in development as well as those commercially available, with appropriate prioritization and use of resources ensuring alignment with corporate goals, regional needs, and therapeutic priorities
Oversee the Design and implementation of Integrated Evidence Generation Plans (IEGPs) that incorporate clinical, real-world, and economic data to support product positioning and value demonstration
Scope RWE studies (Regional/National/Academic/Patient/Vendor), selection of new or existing academic (can include: ISR/lIS/NIS)/non-governmental registries (retrospective/prospective), management across various phases from start up, maintenance to final deliverables
Translate (early) trial efficacy to real-world comparative effectiveness as part of early and late phase study planning, identification of subpopulations, and for potential risk-sharing purposes
Design and implement multiple database and/or de novo (e.g. registries) pharmacoepidemiologic studies, as well as literature reviews, intended to provide insight into background epidemiology, disease state regular care, and/or quantify benefits and/or risks potentially associated with Alfasigma products
Project management oversight – ensuring effective design, initiation and implementation of real world evidence studies, while ensuring effective study protocols and plans, managing budget and milestone tracking, and where appropriate contracting with partner organizations
keep abreast on new data and developments in the field, key publications of interest, research methodologies and regulatory standards across the EU and New Markets regions and proactively address HOR strategy changes in collaboration with global and regional teams in anticipation of any trends
Review and provide relevant RWE/HOR inputs to statistical analysis plans and analysis outputs
Understand the legal and compliance environment and drive collaboration with the Legal and Compliance team
Establish metrics to evaluate the effectiveness and impact of evidence generation activities on corporate and product-specific objectives

What we offer

We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development

Director, Medical Information

Beam is seeking a driven and scientifically rigorous Director of Medical Informa...

Location

United States , Cambridge

Salary:

210000.00 - 260000.00 USD / Year

Beam Therapeutics

Expiration Date

Until further notice

Requirements

Advanced scientific degree required: PharmD, MD, PhD, or equivalent in life sciences, pharmacy, or a related field
Minimum 7 years of experience in Medical Information, Medical Affairs, or Medical Communications within the pharmaceutical or biotechnology industry
Experience contributing to or building Medical Information capabilities, including SOP development and content library management
Solid working knowledge of medical review processes (MRC/PRC) and promotional/non-promotional content review, with familiarity with applicable FDA and EMA regulations
Strong scientific writing skills with experience developing SRDs, medical information responses, and clinical content for internal and external audiences
Ability to work effectively cross-functionally in a fast-paced, pre-commercial biotech environment with lean teams and evolving priorities
Interest in or exposure to rare disease therapeutic areas, including the scientific and operational challenges of small patient populations
Experience in cell and gene therapy, gene editing, or other advanced therapy medicinal products, preferred
Exposure to AI/ML applications in Medical Affairs or Medical Information, including prompt engineering, LLM evaluation, or AI governance, preferred
Familiarity with medical information platforms (e.g., Veeva Vault, Salesforce Health Cloud, MedAnswers) or emerging AI-powered MI solutions, preferred

Job Responsibility

Establish the Medical Information department from the ground up, including defining the operating model, staffing plan, technology infrastructure, and standard operating procedures (SOPs)
Develop and maintain the MI quality framework to ensure all scientific content meets regulatory, compliance, and scientific integrity standards
Serve as the internal subject matter expert on medical information best practices, regulatory expectations (FDA, EMA), and industry benchmarks for rare disease and advanced therapies
Build and oversee the medical review process for promotional and non-promotional materials, ensuring scientific accuracy and alignment with label and clinical data
Partner in the establishment of a Medical Review Committee (MRC) / Promotional Review Committee (PRC), collaborating closely with Regulatory Affairs, Legal, and Commercial teams
Create and maintain a comprehensive library of standard response documents (SRDs), custom responses, and medical FAQs covering the company's cell and gene therapy pipeline across rare disease indications
Author and review medical information letters, disease education materials, clinical summaries, and scientific dossiers for internal and external use
Ensure all MI content reflects the most current evidence base, including clinical trial data, real-world evidence, and peer-reviewed literature
Partner with Medical Science Liaisons (MSLs), Clinical Development, and Commercial teams to develop scientifically rigorous training materials, slide decks, and internal reference tools
Lead the development of pipeline and disease area resources that enable cross-functional teams to communicate accurately about the science of cell and gene therapies

Fulltime

Behavioral Health Medical Director

The Behavioral Health Medical Administrator (Medical Director) directs, leads, a...

Location

United States , Phoenix

Salary:

Not provided

Blue Cross Blue Shield of Arizona

Expiration Date

Until further notice

Requirements

3 years of experience in a clinical setting
1 year of experience in physician leadership role, including quality review, utilization review, population health and other managed care functions
Medical Degree
Active, current, and unrestricted license to practice medicine in the State of Arizona (a state in the United States)
Board Certification in general psychiatry, or adult and child/adolescent psychiatry, through the American Board of Psychiatry and Neurology
Requires knowledge and skills in state (Arizona) and federal behavioral health regulations, requirements for publicly funded services, delivery, operations, and licensure.
Knowledge of managed care concepts and practices
and emerging and best practices for adult & children’s integrated care programs.
Ability to use electronic word processing, email, and electronic database resources.
Excellent customer service and oral/written communication skills

Job Responsibility

Directs, leads, and provides professional oversight for medical management and population health activities related to behavioral health utilization management, case and care management, disease management, performance improvement, and quality management activities.
Supports collaborative relationships with physicians and hospitals to achieve mutually acceptable business goals in compliance with AHCCCS and CMS regulations.
Provides physician leadership and medical oversight in the design, implementation and review of clinical services, best practices, care management, medical management and quality management.
Serves as liaison between the Medicaid Business Segment and medical and behavioral health practitioners at stakeholder and provider agencies.
Participates in aggregate and member-level clinical analyses for quality management, quality of care concerns, peer review, medical management, and utilization review processes.
Reviews and authorizes requests by providers and treatment coordinators for services or programs requiring prior authorization.
Participates in the design and implementation of best practices, clinical standards, protocols, and treatment guidelines.
Participates in credentialing, re-credentialing and competency processes for providers.
Assists care managers with care management of high risk/high-cost members.
Participates as a member or chair of internal and external committees.

Parttime

International Lead Medical Communication

The Lead Medical Affairs Operations & Communications, Poland at Exact Sciences w...

Location

Poland , Warsaw

Salary:

Not provided

Exact Sciences

Expiration Date

Until further notice

Requirements

Medical or Pharmaceutical or Health Science Degree
6+ years of industry experience working in medical affairs in pharma, biotech, and/or med tech
Demonstrated ability to coordinate medical writing with service providers
internal and external authors is a plus
Proven record of working in matrix environment and delivering as part of a cross- functional remote team
Solid track record of multi-project management and execution
Solid track record of process improvement
Solid track record of delivering innovative medical activities across markets
Fluency in the English language (C1 or above per CEFR framework)
Demonstrated ability to perform the Essential Duties of the position with or without accommodation

Job Responsibility

Define, build, and own key medical processes (G&D, IIS, audit, medical materials, KOL engagement, and patient centricity)
Support International Medical Governance model and meetings
Deliver balanced scorecard for International Medical (consistent through countries) that highlights performance with a focus on outcome-based measures
Secure the integration of the different IT systems to International Medical
Support development of medical assessments for future products
Own and manage medical budgets across the region
Plan, support, analysis, publication, and study summaries of investigator-initiated studies and non-interventional studies (e.g., Decision Impact studies), in collaboration with Medical Directors and Global medical team
Leverage medical communications and support creation of medical materials
Screen and evaluate the current scientific literature relevant to the international markets
Support international advisory boards/International Congress, coordinate event planning and support slide developments

Fulltime

Senior Director, Clinical and Regulatory Writing

The Senior Director, Clinical and Regulatory Writing will serve as a strategic l...

Location

United States , Philadelphia

Salary:

Not provided

Cabaletta Bio Inc

Expiration Date

Until further notice

Requirements

Advanced degree in life sciences (M.D., or PharmD preferred)
MS, PhD with significant clinical pharmacology writing experience will be considered
12+ years of progressive experience in regulatory or scientific/medical writing in the biopharmaceutical industry, including 5+ years in a leadership role
Demonstrated experience developing content for major global regulatory submissions (e.g., IND, BLA, MAA), preferably in cell or gene therapy
Strong understanding of drug development processes, regulatory frameworks (FDA, EMA, ICH), and clinical trial documentation requirements
Exceptional writing, editing, and analytical skills with the ability to convey complex scientific data clearly and persuasively
Proven leadership capabilities, including team development, cross-functional collaboration, and vendor management
Proficiency in Microsoft Office Suite, document management systems (e.g., Veeva Vault), and electronic publishing tools
Strong project management skills with the ability to prioritize competing demands in a fast-paced, deadline-driven environment
Collaborative mindset with the ability to influence and guide stakeholders across disciplines and levels of seniority

Job Responsibility

Lead the clinical writing function in the development, review, and approval of regulatory documents to support global submissions (e.g., INDs, IMPDs, BLAs, MAAs, Orphan Drug Applications, Investigator Brochures, protocols, clinical study documents, PSPS/POIPs, Prime, RMAT)
Lead cross-functional content planning of regulatory submission modules, including data integration and interpretation, and ensuring consistency in strategic messaging for dossiers, meeting packages and responses to health authorities
Translate complex technical data from clinical and biostatistics teams into scientifically accurate, submission-ready documentation
Manage external consultants and contractors as needed to support Cabaletta submissions reviews, authoring, if needed, and gap analyses
Mentor, train, and manage a team of medical/regulatory/technical writers or cross-functional contributors in document development
Develop and implement strategic plans for medical writing activities, aligning them with clinical development, regulatory affairs, and overall business goals
Drive process improvements and develop standard practices for efficient, compliant and high-quality document delivery
Collaborate with Clinical Operations and external CROs to ensure inspection readiness of clinical trial documentation, including informed consents, study manuals, and IRB/IBC responses

What we offer

health and retirement, PTO, and stock option plans

New

Associate Creative Director - Pharmaceutical Copy

We are seeking an experienced Associate Creative Director, Copy to join a leadin...

Location

United States , New York

Salary:

90.00 - 100.00 USD / Hour

Solomon Page

Expiration Date

Until further notice

Requirements

8+ years of pharmaceutical advertising agency copywriting experience, with recent experience at the Senior Copywriter, Copy Supervisor, Group Copy Supervisor, or Associate Creative Director level
Extensive experience developing HCP-focused pharmaceutical marketing and promotional materials
Proven success leading creative development within pharmaceutical advertising agencies
Strong understanding of medical/legal/regulatory review processes and FDA promotional guidelines
Expertise in annotations, references, citation management, and claims substantiation
Ability to interpret scientific literature, clinical trial data, and market research and convert insights into compelling creative messaging
Strong presentation, communication, and client-facing skills
Experience collaborating with cross-functional agency teams including Creative, Account, Strategy, Medical, and Regulatory
Exceptional attention to detail, organizational skills, and ability to manage multiple priorities simultaneously

Job Responsibility

Lead the development of strategic, insight-driven creative concepts and messaging platforms for pharmaceutical and healthcare brands targeting healthcare professionals (HCPs)
Write and oversee copy across a variety of channels, including digital, CRM, websites, sales materials, email campaigns, presentations, print collateral, and branded promotional initiatives
Serve as a senior creative partner to account, strategy, medical, and client teams, helping shape campaign direction and brand storytelling
Translate complex clinical, scientific, and market research data into clear, compelling, and compliant messaging
Provide creative leadership and mentorship to copywriters and junior team members, ensuring high-quality creative output
Present creative concepts and rationale confidently to internal stakeholders and clients
Annotate promotional claims and ensure all supporting references and citations are accurate, properly documented, and MLR-ready
Partner closely with Medical, Legal, and Regulatory teams throughout review cycles, incorporating feedback while maintaining strategic integrity
Manage multiple brands, projects, and deadlines in a fast-paced agency environment

What we offer

Medical
Dental
401(k)
Direct deposit
Commuter benefits

Fulltime

Interventional Technologist

As an Interventional Technologist, you will prepare and assist physicians during...

Location

United States , Lincoln

Salary:

30.76 - 45.76 USD / Hour

American Nursing Care

Expiration Date

Until further notice

Requirements

Graduate of a Radiologic Technology Program
BLS from the American Heart Association
ARRT Board Certified in Radiology
Must hold a valid Medical Radiography or General Radiology Technologist Permit to Practice license in Nebraska or Iowa depending on work state
Understands methods and is capable of performing venipuncture’s as required for position
Demonstrated ability to set and maintain multiple priorities in an environment with shifting priorities, while providing accurate deliverables in a timely fashion
Must be self-motivated, and able to take ownership of projects/assignments
Must be a team player with excellent follow-up and customer service skills
Strong interpersonal, verbal, and writing skills
Interpersonal skills in dealing with guests and team members

Job Responsibility

Prepare and assist physicians during complex interventional procedures, ensuring optimal imaging and patient safety
Ready the procedure room, operate advanced imaging equipment, monitor patient vitals, and assist with instruments while maintaining sterile fields
Proper assessment of the patient and their abilities to participate in ordered procedure
Provide a clear explanation of the procedure including duration, process, and what to expect following completion
Verify informed consent for and assist physician with interventional procedures
needle localization, aspiration, biopsies, and other invasive procedures
Practice aseptic and sterile techniques as necessary and observe universal precautions
Provide patient education as appropriate
Select proper equipment, set correct technical factors, procedure protocols and gather proper supplies prior to performance of the procedure
Recognize all radiation safety standards including 'Image Gently' and 'Image Wisely' and MR safety standards

What we offer

Medical
Prescription drug
Dental
Vision plans
Life insurance
Paid time off (full-time benefit eligible team members may receive a minimum of 14 paid time off days, including holidays annually)
Tuition reimbursement
Retirement plan benefit(s) including, but not limited to, 401(k), 403(b), and other defined benefits offerings

Fulltime

Select Country

Director, Medical Writing Lead

Job Description

Job Responsibility

Requirements

Nice to have

What we offer

Looking for more opportunities?