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Senior Executive-clinical Regulatory Writing
hace 3 semanas
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.
**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**:
**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 4,000 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
LI-PB1 #LI-REMOTE
