Founded in 1997, BioMarin is a global biotechnology company dedicated to transforming lives through genetic discovery. The company develops and commercializes targeted therapies that address the root cause of the genetic conditions that it seeks to treat, helping to better the lives of those struggling with rare genetic disease. BioMarin discoveries have led to eight first or best-in-class commercial treatments and a pipeline of multiple product candidates applying the same science-driven, patient-forward approach to broader group of genetic disorders. The more innovative solutions developed, the more lives BioMarin can impact.


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We appreciate your interest in BioMarin & encourage you to visit http://careers.biomarin.com/career-areas to review job opportunities.

Industry: Biotechnology Research
Company Size: 1,001-5,000 employees

BioMarin Pharmaceutical Inc.

Savvy Admin PROD

Who We Are

BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health.

Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities.

Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best – people with the right technical expertise and a relentless drive to solve real problems – and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we’ve produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options.

**About Worldwide Research And Development**

From research and discovery to post-market clinical development, our WWRD engine involves all bench and clinical research and the associated groups that support those endeavors. Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with genetic diseases.

**ROLE:**

The Senior Medical Writer 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.

**RESPONSIBILITIES:**

- 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.

- Works effectively with cross-functional groups within BioMarin

- Other tasks as assigned.

**SCOPE:**

- This position progressively develops the medical writing function in alignment with the requirements of the Development Sciences department and organizational goals.

- Filling this need with a regular full-time employee will enable BioMarin to reduce writing-related CRO and contractor costs, increase Global Medical Writing productivity to meet development needs, and realize efficiencies and consistent documentation quality across programs through repeatable processes and continuity of knowledge of programs, investigational products, and indications.

**EXPERIENCE:**

- 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.

-  Medical Writing:

- 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).

- 2) Clinical Studies

- 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.

- Intermediate to advanced applied knowledge of:

-  documentation required for the conduct of clinical studies

-  protocol design (including objectives, efficacy and safety endpoints, and procedures for collecting and reporting AEs and SAEs)

-  study results reporting

-  integrated results reporting

- Direct experience with documentation in all phases of drug development.

- 3) Regulatory

- Intermediate to advanced knowledge of regulatory requirements and guidances associated with standalone regulatory documents (eg, protocols, investigator brochures, and clinical study reports).

- Prior familiarity with standard eCTD IND/NDA work, including:

-  Modules 2, 3, 4, and 5 of INDs/NDAs in eCTD format

-  Integrated Summary of Safety (ISS), Integrated Summary of Efficacy (ISE)

- 4) Project Management

- Capable of working on multiple tasks and shifting priorities.

- Capable of leading a cross-functional team under strict timelines, including calling/running meetings and managing team review and comment adjudication stages of document preparation.

- Capable of representing Global Medical Writing at cross-functional meetings, advocating for Global Medical Writing, and working with Global Medical Writing line management to resolve cross-functional conflicts.

- Good conflict management skills.

- Motivated and shows initiative.

- Detail oriented.

- 5) Communication

- Capable of well organized, concise and clear written and verbal communication.

- Capable of comprehending complex scientific concepts and translating them into clear, concise, appropriately referenced text that meets regulatory requirements.

- Effective at explaining writing principles to a varied audience both in individual and group settings; intermediate to advanced presentation skills.

**EDUCATION:**

- Bachelor’s or higher degree required; scientific focus desirable.

- Evidence of medical writing career development desirable, eg, American Medical Writers Association certificate, Editor in Life Sciences certificate, or relevant training through Drug Information Association.

**COMPUTER SKILLS:**

- Proficient in Microsoft Word (including the use of templates), Excel, Adobe Acrobat, MS Project/Project Server, and PowerPoint.

- Experience using document management software (eg, LiveLink, SharePoint, Veeva)

- Experienced with scanners, printers, and copiers.

Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

Equal Opportunity Employer/Veterans/Disabled

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Senior Medical Writer

About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. 

For more information, please visit www.thermofisher.com.

Industry: Biotechnology Research
Company Size: 10,001+ employees

Thermo Fisher Scientific

**Work Schedule**

Standard (Mon-Fri)

**Environmental Conditions**

Office

Join Us as a Medical Writer - Make an Impact at the Forefront of Innovation

The Medical Writer provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients. The role involves collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

What You'll Do:

-  Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies.

-  May assist with more complex clinical and scientific and program level documents, including IBs, INDs, and MAAs.

-  Ensure compliance with quality processes and requirements for assigned documents. May assist in determining best practices, methods and techniques for achieving optimal results.

-  May assist in program management activities. Duties could include assisting with developing timelines, budgets, and forecasts for assigned deliverables.

-  Represent the department at project launch meetings, review meetings, and project team meetings.

Education & Experience Requirements:

-  Bachelor's degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification

-  Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years).

-  Experience working in the pharmaceutical/CRO industry preferred

-  Experience in scientific writing advantageous

Years of experience refers to typical years of related experience needed to gain the required knowledge, skills, and abilities necessary to perform the essential functions of the job. Years of experience are not to be used as the only determining factor in establishing the job class or making employment selection decisions.

Knowledge, Skills, Abilities:

-  Solid medical writing skills, including grammatical, editorial, and proofreading skills

-  Ability to interpret and present complex data accurately and concisely

-  Effective administrative, organizational and planning skills; attention to detail and quality

-  Ability to work on own initiative and effectively within a team

-  Effective oral and written communication skills

-  Good knowledge of regulatory documentation and drug development process

-  Great judgment and decision-making skills

-  Good computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

Working Conditions and Environment:

-  Work is performed in an office environment.

-  Exposure to electrical office equipment.

-  Occasional drives to site locations with occasional travel both domestic and international.

-  Long, varied hours required occasionally.

Why Join Us?

When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly make a difference.

Apply today to help us deliver tomorrow’s breakthroughs.

FSP Medical Writer (NA)

Medasource is a leading consulting and professional services firm serving the healthcare industry, including Life Sciences, RCM/Payers, Technology, and Government. We’ve been recognized by both KLAS and Modern Healthcare for being good to our employees, consultants, clients, and communities. With over 100 clients, more than 2,000 active consultants, and over 30 locations across the U.S., we’re focused on propelling the future of healthcare, one client at a time.

Visit medasource.com to learn more today!

Industry: Hospitals and Health Care
Company Size: 501-1,000 employees

Medasource

**Client: Major MedTech compay **

**Position: Medical Technical Writer **

**Location: Hybrid/Remote - based out of Cincinatti, OH **

**Start: ASAP **

**Key Responsibilities **

- Develop, review, and finalize a wide range of preclinical regulatory documents, including but not limited to, Investigator's planning projects, scientific protocols, post studies reports – including biostatistics, post-operative evaluations and reports, help to respond to Q/A edits, help with IACUC protocols documents and submissions, regulatory responses, and briefing documents.

- Support the deployment and integration of GenAI-enabled authoring and review tools, ensuring alignment with regulatory standards and internal SOPs.

- Lead or actively participate in process working groups, providing strategic input to enhance document development workflows.

- Coordinate user acceptance testing (UAT), troubleshoot technical issues, and collaborate with IT teams to optimize document management systems.

- Assist in the rollout of writing digital tools, ensuring seamless adoption and integration across teams.

- Develop and deliver comprehensive training materials for end-users, promoting best practices in document creation and review.

- Monitor system performance, gather user feedback, and recommend enhancements for continuous improvement.

- Maintain current knowledge of emerging AI technologies, regulatory guidance, and industry best practices related to preclinical documentation.

- Ensure all documentation complies with current regulatory standards, industry guidelines, and internal SOPs.

- Support change management activities and assist in process optimization initiatives.

- Complete all required project tracking, metrics reporting, and training documentation within company systems.

- Foster strong, collaborative relationships with cross-functional teams including R&D, Regulatory Affairs, IT, and Quality Assurance.

**Qualifications & Requirements **

- **Education: ** Bachelor’s degree in a scientific discipline is required; advanced degrees (Masters, PhD, MD) are preferred.

- **Experience: **

- Minimum of 10 years of relevant scientific experience, with a strong background in preclinical research or related fields.

- At least 6 years of experience in scientific or medical writing within the preclinical or regulatory domain.

- **Skills: **

- Proven expertise in authoring and managing complex scientific documents and regulatory submissions.

- Familiarity with the document landscape in preclinical research and submissions.

- Experience with digital transformation initiatives and AI-enabled tools in document creation and review.

- Knowledge of document management systems, workflows, and process optimization.

- Excellent oral and written communication skills with a keen eye for detail.

- Strong leadership and project management skills, including influencing, negotiating, and problem-solving.

- Demonstrated learning agility and ability to adapt to evolving technologies and regulatory landscapes.

- Ability to work effectively in a team environment and build productive cross-functional relationships.

**Preferred Skills **

- Business and scientific writing expertise

- Knowledge of preclinical research, trial operations, and regulatory requirements

- Experience with IACUC regulations, scientific experimental design, and protocol development

- Familiarity with 510(k) documentation and submission processes

- Copy editing, proofreading, and data synthesis skills

- Understanding of SOPs, research ethics, and quality standards

- Experience with coaching, training, and process improvement initiatives

**Other Attributes **

- Exceptional organizational and time management skills

- Ability to resolve complex problems independently and under supervision

- Strong interpersonal skills with the ability to influence and collaborate effectively

- Commitment to continuous learning and professional development

Medical Writer

We are BOLDSCIENCE.  

We are a scientifically creative global medical communications agency.  

What exactly does that mean? It means our staff are made up of talented science communicators, artists, and curious disruptors, that collaborate to create impactful communication programs for pharmaceutical clients who need a compelling voice. 

We know what it takes to create brands, to start new conversations, to simply communicate complex science, to change lives… that’s what we’re about. 

We are inspired by our vision to improve lives – for patients, our clients, and the people who work with us.  

As a company, we value BOLDness.  BOLD ambitions. BOLD thinking. BOLD action.  

Are you a prospective client? Tell us about your challenges and we will bring you our BOLD solutions.  

Are you looking to spark your career? Send us your CV and a covering letter to Hello@boldsci.com, telling us about the last time you behaved BOLDly.  

BOLDSCIENCE is part of CO-LAB GLOBAL INC.

Industry: Pharmaceutical Manufacturing
Company Size: 51-200 employees

BOLDSCIENCE

A BOLDSCIENCE Associate Medical Writer (AMW) is a position for those looking for their first step into medical communications. Individuals will not need to have experience working within the industry but, through their higher education and research background, will demonstrate a passion for translating complex science and communicating this engagingly and creatively.

At BOLDSCIENCE, an AMW will learn from the best, receive focused training sessions and in-depth on-the-job mentoring, and immediately be immersed in a spectrum of therapy areas and accounts, including commercial, medical affairs, and publications. An AMW is eager to learn and demonstrates curiosity by regularly asking questions and proactively researching. They are organised and manage their time effectively, ensuring the team is updated on actions. They are not easily phased and can keep a cool head under pressure.

**Day-to-Day Responsibilities: **

At BOLDSCIENCE, no two days are the same, and our AMWs actively support their account and the Scientific Services team. Some typical activities include:

**Technical Writing: **

Under the close supervision and guidance of a senior team member, an AMW will develop content outlines and drafts, including:

- Slide decks

- Digital materials

- Manuscripts and congress publications

- Meeting materials

- Through development and guidance, these materials will be well-researched, technically accurate, well-written, and presentable

- Able to adapt writing and communication style to the relevant target audience

- Ensure written materials meet the project brief and are completed within the specified time allowance allocated for the project

- Ensure written materials meet in-house quality standards

- Proactively volunteers for data checking and performs it accurately and in line with BOLD processes

- Take ownership of developing visual PowerPoint presentations

- Is open to receiving feedback and ensures that feedback is incorporated accurately and carried forward into future work

**Scientific Knowledge: **

- Curious to develop their scientific knowledge on specific therapy areas/client account through proactive research such as reading scientific articles

- Eager to learn about the Medical Communications industry, the healthcare community, and processes at BOLDSCIENCE and within the pharmaceutical industry

- Proactively asks questions to develop their knowledge and expertise

- Learn the internal quality control process, including internal reviews

- Developing the knowledge, skills, and expertise needed to deliver high-quality scientific content to support the team

** **

**Project Management Skills: **

- Organised and effectively manages and prioritises their time across different projects

- Contributes to internal status calls to keep the team updated on actions

- Uses initiative to problem solve and drive to get results. They do not hesitate to draw on senior support where required

- Collaborate and build relationships with the wider BOLD team, including client services and creative

- Meet deadlines and alert their senior scientific team members to their progress, and if a project is taking more time than expected

**Financial Management Skills: **

- Completes timesheets accurately and promptly

- Maintains an average billability of 85–90%

**Required Qualifications: **

- Higher degree in a relevant subject (PhD, MD, PharmD, etc.)

- Writing experience through a higher degree or other activities

- Excellent written and verbal communication skills

- Strong attention to detail and ability to communicate with senior leaders

- Proactive approach and an enthusiasm for trying and learning new skills

- A curious mindset with an eagerness to develop scientific expertise across a range of therapy areas

Associate Medical Writer

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