Author: Marine Dollat

Medical Writer

My client is an innovating, dynamic and growing international medical device company currently expanding their clinical team in Switzerland, Geneve Canton.

Due to this growth my client is looking for a Medical/Scientific Writer.

The position will report to the Head of Clinical Development Department.

 

Your Responsabilities :

       Prepares and finalises clinical documents such as, but not limited to, CSRs and appendices, IBs, protocols and protocol amendments, summary documents, RMPs (initial and updates), regulatory responses, and briefing documents. Documents must be of high quality in terms of scientific content, as well as organisation per regulatory and internal guidance, clarity, and accuracy, with attention to format and consistency;

       Leads cross-functional document planning and review meetings

       Leads in a team environment with greater independence for longer-term activities, and takes a lead role on assigned projects concerning timing, scheduling, and tracking;

       Indirectly or directly leads or sets objectives for others on team projects and tasks; e.g., able to lead process working groups;

       The primary point of contact for Clinical Development Team for medical writing activities;

       Responsible for functional planning and metrics database updates for assigned program.

 

Ihr Profil :

       PhD or Master in elated Pharmaceutical Science with minimum 3 years experience of relevant regulatory medical writing

       Ability to function (and potentially lead) in a team environment;

       Demonstrates learning agility ;

       Builds solid and productive relationships with cross-functional team members;

       Strong project management skills

       Strong leadership skills

       Fluent in English and French

Clinical Data Manager

My client is an innovating, dynamic and growing international medical device company currently expanding their clincal team in Switzerland, Geneve Canton.

Due to this growth my client is looking for a Clinical Data Manager.

Your Responsibilities :

 

Ø Contribute to the definition and the implementation of EDC or paper case record form of clinical studies.

Ø Be in contact with the global authorities.

Ø Leverage EDC development outsourced to external partners and manage related activities including setting up of data transfer agreements and appropriate clinical database reconciliation with internal database (ie safety database)

Ø Act as EDC representative

Ø Setup and lead clinical trial data and EDC specifications, EDC design, edit checks programming

Ø Maintain current awareness of regulations, guidance documents (Data Management Plan, Data Validation Plan…), advisory committees, industry standards, appropriate archiving, GCP and interna SOPs.

Ø Manage user access to the clinical database. Ensure appropriate training is received.

Ø work closely with clinical project manager to ensure quality of clinical data throughout the clinical study lifecycle to lock/unlock and freeze/unfreeze as appropriate for statistical review, interim review or final database lock.

Ø Participate in the development and maintenance of Data management SOPs.

 

Your Profile :

Ø Minimum B.Sc. degree in Biochemistry, Microbiology, Pharmacy, Biological Sciences or Related Pharmaceutical Science ;

Ø Minimum of 4 years of experience in clinical data management.

Ø Strong knowledge of CDISC standards is required ;

Ø Experience in biostatistics and/or SAS programming is a plus ;

Ø Strong critical thinking and problem solving skills ;

Ø Able to rapidly adapt to changing environment and circumstances ;

Ø Fluent in English and French.

Senior Expert CMC Biologics Development

My client is an innovating, dynamic and growing international pharmaceutical company currently expanding their regulatory team in Switzerland, Vaud Canton.

Due to this growth my client is looking for a Senior CMC Expert/Director with experience working on Biologics Product.

Responsabilities :

 

Ø Contribute to the definition and the implementation of the CMC strategy in line with the overall strategy
Ø Provide expertise and leadership in the development, communication and implementation of global CMC strategy in support of product portfolio execution
Ø Ensure a balanced approach to pharmaceutical development risk, understanding the impact to the business and enabling smooth approval of regulatory submissions
Ø Identify proactively critical CMC development issues, escalade them in a timely fashion, contribute to set and implement strategies for their resolution
Ø Review and approve CMC and quality documents (i.e. IND, CTA, BLA)
Ø Contribute to Quality by Design CMC development strategy (e.g Quality Target Product Profile).
Ø Act as POC of the Pharmaceutical Development Department in governance bodies and meetings
Ø Leverage the pharmaceutical expertise to proactively coordinate project cross functional CMC content, in close collaboration with Pharmaceutical Development Functions, external partners and Project Management
Ø Act as Pharmaceutical Development Representative in the Global Project Team
Ø Elaborate with the Heads of Function and SMEs a CMC project development plan including milestones, external costs and internal resources needs
Ø Elaborate with the Heads of Function and SMEs a risk management table, update it as necessary and escalade in a timely manner any critical risk
Ø Work closely with CMC Regulatory Affairs and ensure alignment regarding questions and strategies, driving development of science based argumentation to obtain buy-in of regulatory agencies, together with appropriate Heads of Function and SMEs
Ø Attend CMC meetings with Health Authorities (e.g. FDA, PMDA, EMA) and act as CMC representative
Ø Ensure liaison and coordination between Pharmaceutical Development Department and Operations
Ø Support external partner oversight and management of CMC Expertise
Ø Develop and nurture a network of CMC experts to support strategy
Ø Proactively contribute to implement regional regulatory requirements and guidelines that impact pharmaceutical development activities

Ø Maintain current awareness of regulations, guidance documents, advisory committees, industry standards, scientific literature and trends that are applicable to current and future Development
Ø Communicate this within the Team and to other staff, as appropriate, and provide key strategic pharmaceutical development expertise inputs to projects and cross-functional teams
Ø May publish/present in high quality journals/conferences
Ø Lead working groups to develop internal policy or guideline

 

Your profile :

 

Ø Pharmacist, PhD, MS in biological sciences, biochemical engineering, or a related discipline, concentration in microbiology, biochemistry might be a plus
Ø Minimum 15 years experience in the pharmaceutical industry and 8-10 years in CMC expertise supporting worldwide product development in the related field
Ø Demonstrated understanding of CMC development in the field of biologics (e.g. cell culture, upstream and downstream process, analytical sciences including characterization and comparability studies, combination product,  technology transfer), including Quality by Design methodology
Ø Demonstrated experience in developing and implementing CMC work plans to support phase appropriate activities, including management of timelines and budget
Ø Strong knowledge in developing and implementing risk management
Ø Strong experience in authoring/reviewing regulatory documents (e.g. IND/IMPD, BLA) and in supporting registration process
Ø Demonstrated ability to set CMC strategy and to interact with competent authorities
Ø Effective leadership, project management, interpersonal skills
Ø Excellent verbal and written communication (English)
Ø Ability to lead and promote changes
Ø Ability to solve complex problems and to propose innovative solutions
Ø Demonstrated knowledge of cGMP requirements

Senior Biostatistician

My client is an innovating, dynamic and niche international privately-owned biopharma company currently expanding their Statistic team in Switzerland, Lausanne area. Due to this growth my client is looking for a Senior Biostatistician to join their team.

YOUR RESPONSABILITES :

 

Ø Provide statistical programming expertise

Ø Coordinate all statistical programming related tasks.

Ø Works closely with all departements and CRO for all statistical programming related activities, including development and validation of ADaM.

Ø Create derived data set specifications for all assigned studies and integrated summaries.

Ø Review statistical analysis plans for all assigned studies and integrated summaries and provide comments to study biostatistician.

Ø Review annotated case report forms and provides comments.

Ø Contribute to process improvement initiatives as assigned.

 

YOUR PROFIL :

 

Ø Master’s or Bachelor Degree in Statistics,Computer Science, with an experience of minimum 5 years  in pharmaceutical industry.

Ø Strong SAS programming language

Ø Strong knowledge of CDISC Standards

Ø Good understanding in statistical methods used in statistical analysis.

Ø Good knowledge within GCP

Ø Fluent in English