Senior Executive-Clinical Regulatory Writing Consultant

Are you interested in working directly for a single sponsor while having the security and additional career opportunities that working for a global CRO can bring? Our team says it’s the best of both worlds….

ClinChoice is searching for a Senior Executive-Clinical Regulatory Writing Consultant to join one of our clients.

ClinChoice is a global full-service CRO with a strong focus on quality professional development and supportive culture. As a client-facing role we are looking for confident candidates with the ability to work independently whilst establishing a high-trust environment with the client’s counterparts.

Main Job Tasks and Responsibilities:

The Medical Writer will research create edit and coordinate the

production of clinical and regulatory submission documents including

clinical study reports protocols informed consent forms etc.

The Medical Writer may provide writing support for more complex

clinical documentation with appropriate departmental supervision.

The Medical Writer may serve as primary contact with client under

appropriate departmental supervision.

Developing efficient work plans and timelines for medical writing

deliverables.

Serve as quality control person for the clinical regulatory documents and

peer review clinical documents.

Ensure document content and style adheres to appropriate regulatory

guidelines and complies with departmental and corporate or client SOPs

and style guidelines

Ensure that all work is complete and of high quality prior to team

distribution or distribution to client.

Perform literature searches/reviews as necessary to obtain background

information for development of documents.

Attend internal technical team and client team meetings as required

Keep up with professional information and trends in the writing and

regulatory industry through workshops and conferences and ensure the

appropriate transfer of that information to the department.

Participate in departmental process improvement and training initiatives.

Other assignment duties as assigned by department management.

Procedures

Responsible for confidentiality integrity availability and safeguarding

of data

Responsible for reporting of security incidents and PIMS breaches as

applicable

Comply with company QMS ISMS and PIMS requirements and

applicable regulatory requirements

Demonstrate adherence and compliance to PIMS/GDPR requirements as

follows: processed fairly transparently and lawfully; collected for

specified and legitimate purposes; adequate relevant and limited to the

specified purposes; processed in a secure manner.

Education and Experience:

• Pharm M. Pharm M.Sc. Life Sciences PhD Pharm D and in alignment with

project / business team requirements.

Minimum 3 to 5 years of relevant experience in identified functional domain/ business work stream.

Specific Role Requirements and Skills:

Looking for specific experience involves both Investigator Brochures and Clinical Overviews for labeling changes.

The Application Process

Once you have submitted your CV you will receive an acknowledgement that we received it. If you have the requirements we need you will be invited for phone interview as the first step.  Unfortunately due to the number of applications we receive we cannot reply to everyone individually if you are not successful.

Who will you be working for?

About ClinChoice

ClinChoice is a global full-service CRO specializing in clinical development and functional solutions for pharmaceutical biotechnology medical device and consumer health companies. We have over 28 years of proven high-quality delivery and results across all our services with over 4000 professionals in more than 20 countries across the Americas Europe and Asia-Pacific.

Our Company Ethos

Our mission drives our culture: to contribute to a healthier and safer world by accelerating the development and commercialization of innovative drugs and devices. Our employees are the most valuable company asset and they are  the fulcrum around which all ClinChoice activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives all personnel the clear tools needed to manage both internal and client processes with the same methodology.   The success of these core values is evidenced by our below industry average turnover rates.

ClinChoice is an equal opportunity employer. We have based our success on attracting developing and promoting talent guided by diversity and inclusivity. Our employees come from very diverse backgrounds: gender race beliefs and ethnicities. We recognize this is our strength and celebrate it.

Key words: Medical Writing Clinical Medical Writing

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