Senior Regulatory Writer Job at CK Group (Allschwil)

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

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

Content Strategy Manager

Terra is seeking a Content Strategy Manager able to craft novel strategies and c...

Location

United States

Salary:

Not provided

Terra

Expiration Date

Until further notice

Requirements

7+ years of experience, including at a creative or digital agency
Experience leading client-facing projects and crafting effective content strategies
Strong communicator confident presenting recommendations to senior stakeholders
Skilled writer and editor producing polished, high-impact content across formats
Brings clarity, consistency, and creativity to content ensuring alignment with brand voice, business goals, and audience needs
Deeply familiar with or highly motivated to learn the nuances of the healthcare sector
Collaborative, confident leader excelling at building relationships and working with cross-functional teams
Detail-oriented and highly organized
Skilled at managing time and establishing priorities while remaining flexible
Skilled at creating presentation decks that clearly articulate strategic recommendations

Job Responsibility

Collaborate with clients to define project goals and present strategic recommendations
Develop tailored content strategies that align with business objectives, audience needs, brand voice, and regulatory guidance
Conduct and apply research to inform recommendations and content development
Write and edit content across formats, ensuring clarity, accuracy, and alignment with brand and compliance standards
Ensure all deliverables meet or exceed expectations through thoughtful execution and independent ownership of workstreams
Work closely with the client to gather input, align on messaging, and respond to feedback across iterative review cycles
Help develop toolkits, templates, and guidelines that support content rollout
Build strong relationships with client teams through proactive communication, strategic insight, and reliable delivery
Partner with SEO, paid media, design, and development teams to ensure seamless delivery of multichannel, multiformat content campaigns
Identify opportunities to improve content processes, strengthen strategic alignment, and enhance the overall partnership

What we offer

Unlimited paid time off
11 observed holidays
4 mental wellness days per year
100% company funded health insurance, with dental and vision options
Paid parental leave
401(k) plan
Permanent remote work option
Summer Fridays (office closes at 3:00 PM)
Fall/Winter/Spring Fridays (office closes at 5:00 PM)
Monthly wellness stipend

Fulltime

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...

Location

United States; Canada , Remote; Alberta

Salary:

Not provided

Parexel

Expiration Date

Until further notice

Requirements

Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
Good knowledge of drug safety and the drug development process
Good knowledge/understanding of medical terminology
Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
US Board Certification/board eligibility or regional equivalent for Canada
Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
Completion of at least basic training in clinical medicine (residency, internship etc.)
Demonstrated success in technical proficiency and scientific creativity
Good presentation and verbal/written communication skills

Job Responsibility

Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
as applicable) and liaising with the client, as require
Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
Review appropriateness of medical content in narrative for medical coherence
Assessing seriousness, listedness / expectedness of reported events
Providing medical inputs to case processing team
Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative

What we offer

Flexible approach to work that meets your personal needs
Work from home
Benefits vary by country
Investment in your professional and personal development

New

Seo Content Writer

We are seeking an experienced SEO Content Writer to create and lead high-impact ...

Location

Canada , Montreal

Salary:

Not provided

BrainFinance

Expiration Date

Until further notice

Requirements

Proven experience as a senior copywriter, content writer, or content strategist, with a strong portfolio demonstrating expertise in finance or FinTech content or in environments involving high content complexity
Exceptional writing and editorial skills, with the ability to adapt tone, style, and complexity to different audiences and platforms
Advanced knowledge of SEO-driven content strategy, including pillar/cluster frameworks, GEO targeting, and E-E-A-T principles
Strong experience in writing and structuring SEO-driven web content, with a deep understanding of search intent, organic performance, and traffic growth challenges
Excellent command of CMS platforms and digital environments, with the ability to work comfortably in a website’s back end and manage content structures
Strong familiarity with modern technology tools, including SEO tools, collaboration platforms, and artificial intelligence solutions applied to content
Strong ability to work autonomously while collaborating effectively with cross-functional teams
Excellent research, analytical, and communication skills, with a strong attention to detail and content quality
A tech-savvy, curious profile, comfortable in evolving digital environments, with the ability to quickly learn and adapt to new tools and systems

Job Responsibility

Define and deploy a pillar–cluster content strategy across blogs, websites, and social platforms, including the planning and writing of pillar pages, cluster articles, sub-clusters, and supporting content
Own the SEO performance of web content (page structure, search intent, internal linking, on-page optimization) and actively contribute to achieving organic growth objectives
Use artificial intelligence (AI) tools on a daily basis to support research, generate ideas, and optimize content, while maintaining a critical eye to ensure quality, accuracy, and added value
Review and improve internal and external documents (presentations, marketing communications, emails, etc.) to ensure clarity, consistency, and high editorial standards
Conduct in-depth, data-driven research on personal finance topics (budgeting, credit management, consumer financial behaviors) to produce expert, high-value content
Write clear, engaging, and accurate content that simplifies complex financial and FinTech concepts, while ensuring credibility, compliance, and trust with a B2C audience
Apply advanced SEO and content optimization practices, including keyword strategy, metadata optimization, internal linking, on-page SEO, and adherence to E-E-A-T principles to maximize organic performance
Contribute to the development and improvement of content briefs by providing strategic insights, challenging assumptions, and proposing creative ideas aligned with business objectives
Ensure all content complies with regulatory requirements and the specifics of the Canadian financial framework, maintaining a high level of consistency, accuracy, and relevance
Manage content production timelines by effectively prioritizing deliverables to meet deadlines, while maintaining high editorial quality standards across all digital channels

What we offer

Group Insurance (Health and Dental)
Retirement Savings Plan (RSP)
Virtual healthcare
Employee Assistance Program (EAP)
Hybrid - Office / remote (the team is in the office on Wednesdays)
Additional Days off (Moving day, Birthday, 5 personal days)
Health and Wellness Program
Office perks: Event Coordinator responsible for social activities, 5-7, snacks provided, yoga and meditation room
Paid subscription to training tools
Benefits for public transportation (Bixi, Opus)

Fulltime

Regulatory Writing Senior Manager

In this key role you will serve as the functional area lead on product teams, le...

Location

United States

Salary:

152684.00 - 193308.00 USD / Year

Amgen

Expiration Date

Until further notice

Requirements

Doctorate degree and 2 years of directly related experience
Master’s degree and 6 years of directly related experience
Bachelor’s degree and 8 years of directly related experience
Associate’s degree and 10 years of directly related experience
High school diploma / GED and 12 years of directly related experience
Experience with regulatory documents in Regulatory Affairs, Research, Development or related area
5+ years of experience in medical writing in the Biotech/Pharmaceutical industry

Job Responsibility

Author or oversee the authoring of all regulatory submission documents including Clinical Study Reports, Investigator Brochures, Responses to Questions, Protocols, Protocol Amendments, Informed Consent Forms, Table of All Studies, Clinical Overview Addenda, eCTD Module 2 Clinical Summary Documents, Briefing Documents, and Pediatric Investigation Plans
Conduct the formal review and approval of authored documents, following applicable standard operating procedures
With limited supervision, lead regulatory writing activities for complex product submissions, including new and supplemental drug applications/biologics license applications
Serve as functional area lead on product teams (e.g., Global Regulatory Team, Evidence Generation Team, Global Safety Team, Label Working Group)
Provide functional area input for Global Regulatory Plan and team goals
Supervise the work of contract and freelance writers and mentor junior medical writers as assigned
Lead departmental and cross-departmental initiatives, as appropriate
Generate document timelines

What we offer

Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
Stock-based long-term incentives
Award-winning time-off plans and bi-annual company-wide shutdowns
Flexible work models, including remote work arrangements, where possible

Fulltime

Senior Medical Writer

The Senior Medical Writer applies advanced documentation preparation and documen...

Location

United States

Salary:

142100.00 - 159500.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Up to 6 years of as a medical writer in the pharmaceutical industry – OR - at least 10 years of medical or scientific writing experience as a primary job responsibility
Experience writing, reviewing, or editing protocols and clinical study reports required
Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred
Experience writing, reviewing, or editing regulatory briefing books preferred
Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content
Ability to interpret and create complex tabular and graphical clinical data presentations
Advanced applied knowledge of basic clinical laboratory tests
Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets
Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection

Job Responsibility

Applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PBRERs, DSURs, etc.)
Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries)
Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Represents Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams)
Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives (eligibility may vary based on role)
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Senior Medical Writer

The Senior Medical Writer applies advanced documentation preparation and documen...

Location

United States , San Rafael

Salary:

116000.00 - 159500.00 USD / Year

BioMarin Pharmaceutical

Expiration Date

Until further notice

Requirements

Up to 6 years of as a medical writer in the pharmaceutical industry – OR - at least 10 years of medical or scientific writing experience as a primary job responsibility
Experience writing, reviewing, or editing protocols and clinical study reports required
Experience writing, reviewing, or editing INDs, BLA/NDAs, PBRERs, DSURs, and PAERs highly preferred
Experience writing, reviewing, or editing regulatory briefing books preferred
Advanced applied knowledge of routine document content preparation, including the use of style guides (internal, AMA, CBE, Chicago), medical dictionaries, and guidance documents that prescribe content
Ability to interpret and create complex tabular and graphical clinical data presentations
Advanced applied knowledge of basic clinical laboratory tests
Understanding of the concepts of coding dictionaries (MedDRA, WHO Drug)
Advanced understanding of the drug development process (discovery to market), biostatistical and clinical research concepts, clinical study conduct, clinical study data collection, database management, data integration, and generation of datasets
Intermediate to advanced understanding of scientific concepts integral to nonclinical development, CMC, PK, PD, and antibody detection

Job Responsibility

Applies advanced documentation preparation and document project management skills to assist in the development, drafting, review, editing, and finalization of documents used in conducting clinical studies and reporting clinical study results for regulatory submissions and publications
Drafts and edits documents used in conducting and reporting the results of clinical studies, including protocols, protocol amendments, informed consent forms, and clinical study reports
Drafts and edits documents used in reporting aggregate safety and efficacy information for a molecule, such as investigator’s brochures and periodic safety reports (PBRERs, DSURs, etc.)
Drafts and edits documents used in the preparation of regulatory filings (eg, briefing books, eCTD Module 2/Module 5 clinical or integrated summaries)
Manages study team participation in the preparation of such documents, including calling/running meetings, developing and managing timelines, and managing the document review and comment adjudication processes
Represents Global Medical Writing at cross-functional team meetings (eg, study team, development team, other subteams)
Builds effective partnerships with cross-functional groups to ensure customer/stakeholder needs are met
Provides peer review and editing support for other regulatory documents, such as statistical analysis plans, CRFs, and other study materials
Assists in developing and reviewing standard processes and templates within Global Medical Writing, and may also review/consult on the development of standard processes and templates in other departments
Adheres to departmental procedures and practices and technical and industry standards during all aspects of work

What we offer

Discretionary annual bonus
Discretionary stock-based long-term incentives
Paid time off
Company-sponsored medical, dental, vision, and life insurance plans

Fulltime

Senior Regulatory Writer

CK Group

Location:
Switzerland , Allschwil

Category:
Pharmacy

Contract Type:
Not provided

Salary:

Job Description:

Job Responsibility:

Requirements:

Nice to have:

Additional Information:

Job Posted:
May 05, 2026

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