Senior Medical Writer

About the role

An exciting opportunity has arisen for a highly experienced, proactive Senior Medical Writer, with strong project management skills, to join tranScrip; 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.

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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.

Key Requirements and Competencies for the Ideal Candidate

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.