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Senior Medical Writer
2 months ago
About the role
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.
