About the role
Candidates should take the time to read all the elements of this job advert carefully Please make your application promptly.
An exciting opportunity has arisen for a highly experienced, proactive Senior Medical Writer, with strong project management skills, to join tranScrip Ltd; a highly specialist pharmaceutical consultancy that provides strategic expertise, therapeutic experience and operational excellence across the entire product lifecycle, supporting clients globally.
This is a dynamic role with an extremely varied workload in a rapidly expanding company. Responsibilities include project writing and requires a flexible individual who can adapt to client priorities.
Duties and responsibilities
* Be able to understand and interpret study designs and clinical trial data.
* Be able to multi-task, usually working on more than one project at any point in time and have non-project responsibilities.
* Work with a wide variety of Clients and tranScrip’s therapeutic and development teams.
* Willing to take on non-project responsibilities such as:
* Identification, interview and recommendation of excellent subcontractor Medical Writers.
* Proactive support managing medical writing subcontractor project work from a scope, quality, time and cost basis.
* Support to scope, cost and ensure quality of client proposals.
* Leadership or support of key business initiatives.
* Lead or support training to the company.
* Assist project teams and colleagues on a planned or ad hoc basis.
* Train and mentor junior members of the team.
Experience
* Have experience preparing a wide range of high-quality regulatory, clinical, and scientific content documents across a diverse array of documents including regulatory dossier elements, protocols, clinical study reports, briefing books, investigator brochures etc (Some medical communication work may also be required).
* A minimum of 5 years’ experience as a Regulatory Medical Writer in the pharmaceutical/biotech industry, ideally in a CRO environment (10 year’s experience would be advantageous).
* Experience in a wide range of indications would be advantageous.
* Proven track record in preparing clinical and regulatory documents without supervision.
* Proven track record in cross functional management of teams for document development.
* Proficient use of Endnote and internet searches including PubMed an advantage.
* Excellent project management and planning skills, able to manage budgets.
* Experience and willingness to support BD efforts.
Qualifications
* Life science degree, preferably a higher degree (e.g. MSc, PhD).
Personal attributes
* Self-motivated in both terms of personal development and project work.
* Flexible and willing to adapt, in a fast-changing environment.
* Able to work well under pressure.
* Pro-active, with excellent time management.
* Good analytical/strategic skills.
* Good knowledge of local and national guidance and regulations relevant to medical and regulatory writing.
* Outstanding written and oral communication skills.
* Excellent level of IT literacy (particularly with Microsoft Office suite).
* Good interpersonal skills and team-working capabilities.
* Able to travel, if needed (minimal expected).
Benefits
This is a fantastic opportunity within a rapidly growing company offering excellent benefits including:
* Permanent contract of employment.
* Competitive base salary.
* Bonus scheme.
* Pension scheme.
* Life assurance.
* Group income protection.
* Private health insurance and travel insurance.
* Retail discounts.
* Strong focus on CPD.
Location
* The position of Senior Medical Writer will be office-based but some home-working, a genuine possibility for the right candidate.
* Remote possible.