About me

I particularly understand pharmaceutical and medical device industry regulations - this skill transfers to other regulated industries. I understand biological and chemical molecules and how they behave.

The pharmaceutical and medical device sectors, including diagnostics, focus on human and animal health. My experience transfers to agriculture-related sectors, for example, AgBiotech including food production and environmental health.

My GCP, GMP, and ISO work gives me an understanding of compliance. ICH is important to human health, and VICH is important to animal health. One Health addresses animal-human-environment interface health threats.

I am a competent and communicative writer who bridges gaps between industry and life sciences. I understand how regulatory and quality compliance impact the global product value chain.

I am a responsive “go-to” person and team player, strengthening arguments that pursue a line of inquiry to get products into marketplaces.

Tell me how you are unique and see if my specialised consulting and writing services can tailor to your needs.

Contact me if you are seeking expert guidance and comprehensive solutions in the dynamic field of biotechnology.

a close up of a blue and purple structure. Photo by Sangharsh Lohakare, Unsplash.

intro

Ways I help include:

    • Collaborating with leadership and teams to validate regulatory and scientific information.
    • Condensing large amounts of technical information into easier-to-digest reports.
    • Collaborating with leadership and teams to prepare reports and common technical document (CTD) sections for regulatory submissions.
    • Responding to regulatory intelligence requests, for example, concerning clinical trial product labelling and supply chain logistics.
    • Supporting leadership and teams in manufacturing and supply chain operations activities.
    • Providing regulatory authority inspection support, including preparation.
    • Supporting leadership and teams transitioning products from old regulations to new regulations.
    • Providing training and mentorship along the way.

Message Me

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I have:

  • Prepared a variety of industry documents that meet regulatory requirements. This has contributed to my continuous learning of regulations which are always being improved by regional regulators.
  • Worked on quality management for products distributed to and stored at clinical trial sites. This strengthened my understanding of how regulations apply to clinical trial and marketed products manufacturing and distribution.
  • Graduated from an industry-accepted Qualified Person course. This bolstered my understanding of where regulations and manufacturing operations meet.
  • Worked as a clinical trial auditor, so I reviewed Essential Documents listed in ICH GCP. GCP auditing allowed my regulatory understanding to flourish.
  • Written medical device industry clinical evaluation reports and developed the clinical evaluation procedures for a medical device company.

If you are looking for someone who is down to earth, approachable, engaging, communicative, inspiring, analytical, problem-solving, creative, detail oriented, organised, adaptable, motivated, and driven look no further because I am those things. I like journeys towards innovation and success.

Things that resonate with me include pharmaceutical and medical device production and distribution, agriculture, animal health, antimicrobial resistance, biotechnology, combination products, compliance, countryside management, crop spoilage, the environment and environmental health, food production, gene pools, GMO, grassland management, human health, life science, One Health, regulations, quality management, and zoonoses.

Let me know how I can support your goals and help drive your projects forward.

Testimonials

What people say about working with me...

Jennifer was really great to work with. She brought huge energy and drive and was delivering results immediately. This required understanding of the science and converting it to industry ready material. She was completely self-motivated, only had to define the objectives and she produced the results time and again. This technical competence, attention to detail and commitment to task make her a great asset to any team.

Business Development Manager, Centre for Research on Adaptive Nanostructures and Nanodevices (CRANN), 2010

... [Jen] has excellent written and verbal communication skills, is extremely organized, works well independently, and shows great individual initiative…

Recommendation letter, 2010

... [Jen] is capable of both writing and speaking well about science. In personal terms, she is always cheerful, even in the face of setbacks, and interacts well with others...

Principal Investigator and Lecturer, University of Edinburgh, 2011

... [Jen is] articulate, very conscientious, highly intelligent and very motivated. She has a strong desire to get to grips with any task that she is given and she was able to complete her tasks to agreed deadlines. She has good interpersonal skills, got on well with everybody, and is a team player...

Recommendation letter, 2011

... [Jen’s] work predominantly involved review of the clinical evaluation process, and review of clinical papers for products including surgical instrumentation, implants and software. This required her to cover a wide range of technical areas and to interact with a number of project teams. Jennifer addressed these tasks with a high degree of technical competency...

Recommendation letter, 2011

Jen has a lot of relevant knowledge and enthusiasm to learn, which has helped enormously. She is highly motivated, communicative, and efficient at turning around assignments, asking for clarification when necessary and delivering on time.

European Editor, International Pharmaceutical Quality (IPQ) Publications, 2022

Jen is great to work with and very passionate about regulatory and writing. We successfully navigated through challenging intel work and impressed the client with our final deliverables.

Regulatory intelligence medical writing team colleague, 2022

... We appreciated [Jen's] help, as the information [she] provided many times “saved” us...

Email communication, 2023

... [Jen is] our “go to” person for jobs outside our formal job descriptions...

Verbal communication, 2023

... Thank you [Jen] so much for this feedback, this is indeed very helpful...

Email communication, 2024

Get help for your next compliance or life science writing project

Supporting the product lifecycle from discovery into the marketplace.

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