regulatory clinical trial application submission manager in high wycombe

posted
12 April 2019
contact
ruby willard, randstad cpe
job type
contract
salary
Competitive
apply now

posted
location
high wycombe, south east
specialism
pharmaceutical
sub specialism
Quality
job type
contract
working hours
Full-Time
salary
Competitive
reference number
RCTSAMJHW
contact
ruby willard, randstad cpe
apply now

job description

Are you looking for a new role as a Regulatory Clinical Trial Application Submission Manager? Do you want to be responsible for managing regulatory Clinical Trial Applications submission activities for assigned clinical trials Phase 1 - Phase 4? If the answer is yes, this role is for you!

This role covers five therapeutic areas; Oncology, Neuroscience, Cardiovascular and Metabolism, Immunology, and Infectious Disease.

You will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.

The successful candidate will have in depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills.

This is a new contract opportunity playing a key role whilst working for a leading Pharmaceutical business in the Buckinghamshire area. This contract is offered initially on an 8 month basis.

Benefits:



* Free on site parking
* On site gym
* Subsidised restaurants and branded coffee shops
* Competitive pay
* Weekly pay
* Pension contributions

Duties:



* Ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team (CTA Working Group [WG]) that will compile, publish and produce Clinical Trial Authorisation Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.)
* Either submit the CTAs directly to Health Authorities, or facilitate the CTA submission by local personnel in a given country
* Responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs
* Manage the Output Protection Process for assigned trials and ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-own tracking system
* Identifies and proactively responds to issues, problems, or opportunities as it relates to the leading the CTA workgroup
* Independently identifies the need for and collects information (from CTA working groups, GCO, HA-interactions, Local Operating Companies, Regional offices etc.) to better understand and resolve issues/challenges and seize opportunities
* Integrates information from a variety of sources, detects trends, associations, and cause-effect relationships and communicates to supervisor, CTA working group and others as appropriate
* Proposes relevant options for addressing problems or opportunities to supervisor

Experience and qualifications:



* Bachelor's degree required or equivalent experience
* Science degree or related experience with pharmaceutical or health sciences industry is required
* knowledgeable with scientific terminology
* Ideal candidate would possess a minimum experience within regulatory affairs in the pharmaceutical industry
* An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required
* Must have strong communication skills written and verbal
* Must have strong project management skills (e.g. planning, prioritization, management of schedules and timelines, detail orientation, strong sense of urgency)
* Ability to lead complex projects and a high degree of problem solving capability required
* Must have a high level of Self-Awareness and Adaptability and strong impact and influencing skills
* Must have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organisation
* Must be able to work independently, strong initiative
* Experience with GMO submissions would be preferred

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our clients needs.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.