We are growing, grow with us!
Are you looking for a dynamic company with daily new challenges and opportunities?
Then, Pharmalex is your career opportunity! Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the market development and any action of effective product maintenance.
Senior Manager, Scientific Writing
Your Job
- Writing of deliverables (e.g., but not limited to non clinical and/or clinical study documentation, CTD Modules, Orphan Drug Designations or Pediatric Investigation Plans, etc.) in accordance with the applicable regulations in force and in compliance with the commitments made to clients
- Manage the writing of dossiers in full autonomy in coordination with Project Manager and rest of the team, as applicable
- Act as Lead Medical Writer or support the Lead MW, as appliable
- Participate in local, regional or multi-countries or cross-VDCs projects, as applicable
- Identify additional resource/ staffing needs and report to Management
- Liaise with clients and set up recurrent meetings with clients/counterparts, as needed
- Stay up to date with scientific developments relevant for the portfolio of the clients
- Participate in Gap Analysis aimed at identifying deficiencies in draft/old dossiers developed by Clients
- Contribute to the development of Proposals for clients incl. a Medical/Scientific Writing scope of work
- As applicable, manage a team (mentoring, personal development, annual performance reviews, holidays, etc.)
- Ensure compliance with deadlines and the quality of the files submitted to customers
- Contribute to regulatory intelligence and maintain high level of knowledge in MW activities
Your Profile
- University degree in pharmacy or other discipline in Life sciences with a minimum 10 years of professional experience, excellent knowledge of Drug Development and related Agencies requirements
- 3 to 5 years of professional experience as Medical/Scientific Writer including project management experience
- Fluent in English both written and spoken, and French (spoken, possibly as a 2nd language)
- Strong knowledge of European & US regulatory requirements for medicinal products
- Ability to manage and lead a project in full autonomy; management of teams in an international matrix organization and excellent team player
- Very good written and spoken communication skills with internal and external customers, colleagues and management; Ability to develop and deliver presentations
- Ability to analyse information rapidly and to identify and offer solutions to problems in a pragmatic way
- Ability to adjust rapidly to new, unknown, challenging situations
- Business and customer oriented
- Independent approach to work, flexibility and dedication
- Strong sense of responsibility, organizational skills, and intrinsic motivation
- Good knowledge of the Microsoft Office package
If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receive your application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.
For further information please don’t hesitate to contact us.
Agencies only by prior agreement for the specific job opportunity.