Medical Writer
With its beginnings in a family run pharmacy in Correggio, Italy in the 1920s, Recordati is now a global pharmaceutical company, listed on the Italian stock exchange, with over 4,500 employees and turnover of over Euro 2bn.
We are a group of like-minded, passionate individuals who go to extraordinary lengths for our patients, customers, partners, investors and the people across the globe who we serve. We develop and commercialise medicines to serve people living with common diseases, as well as those living with some of the rarest, in around 150 countries.
At Recordati, our mantra is simple. We’ve always believed that health, and the opportunity to live life to the fullest, is a right, not a privilege. Whether that is for common diseases or the rarest – we want to give people the opportunity to be the best version of themselves.
This drive will never stop. Together, we will always be reimagining tomorrow – with new ideas, new technologies and new innovations to fight diseases.
Recordati. Unlocking the full potential of life.
- Support the Senior Medical Writing Manager in the preparation, editing and compilation of various clinical documents for regulatory submission during all phases of clinical drug development and post‐marketing studies.
- Independently prepare clinical study documentation, including Patient Safety Narratives, Patient Lay Summaries, patient consent forms, dossier related documentation (such as Clinical summaries, Briefing Books, PDCO submissions), with support from other functions.
- Support the senior MW manager in the preparation of Clinical Study Protocol and Reports and IB across various therapeutic areas.
- Perform the quality control (QC) review of clinical study documentation when requested.
- Tabulate clinical studies results.
- Perform on-line clinical literature search, as requested. Maintains familiarity with current industry practices and regulatory requirements and guidelines. Ensure controlled and accurate use of medical and scientific terminology.
- Support in redaction of clinical documents in accordance with EU Clinical Trial Regulation, EMA Policy 0070 and other global regulations.
- Support the redaction of the Standard Operating Procedures.
- Responsible for the compilation and publication of trial data in relevant registries with support from the relevant Medical Director.
- Participation in cross‐functional global team meetings.
- Collaborate with Clinical Study Managers, Project Leaders, Clinical trial Application Manager, Regulatory development lead, Biostatistics, Patent and Legal, to ensure awareness of data sharing requests and proper safeguarding of the data in collaboration with the company DPO, where applicable.
- Collaborate with Clinical Operations, Global Project Teams, and other stakeholders to operationalize and develop novel processes related to redaction requirements.
- Interact with Project Teams irrespective of global location.
- Work closely with Clinical Operation and Development Teams, for both SPC & Rare Diseases BUs, Medical Affairs, Regulatory Affairs, Quality Assurance, Portfolio Management and other functions, as appropriate.
- 5+ years’ experience as a Medical Writer in the CRO/pharmaceutical industry.
- Strong portfolio demonstrating a track record of creating clear, concise, and scientifically accurate documents, such as clinical study reports, regulatory submissions, and scientific publications.
- Familiarity with various therapeutic areas and drug development processes.
- Excellent writing and editing skills, with a keen eye for details and the ability to interpret complex scientific and clinical data and present it clearly. Proficient in creating a variety of documents (clinical protocols, clinical reports, investigator brochures, and regulatory documents).
- Regulatory knowledge: Understanding of regulatory guidelines and requirements related to clinical research and drug development (e.g., ICH guidelines).
- Experience with preparing documents for regulatory submissions (e.g., INDs, NDAs, MAAs) is highly desirable.
- Excellent communication skills, both written and verbal, with proven ability to interact effectively within a cross-functional team and with external experts.
- Demonstrated ability to anticipate and resolve problems on projects.
- Proven ability to report project details clearly to various stakeholders within and outside of the company.
- Strong adaptability to evolving project requirements, guidelines, and industry standards.
- Commitment to continuous professional development, to stay updated on the latest developments in scientific research.
At Recordati we believe in people! Inspired by our purpose - unlocking the full potential of life - we are committed to creating a diverse environment and cultivating a culture of inclusion. We strive to continually lead with our values and beliefs, enabling our employees to bring their whole selves to work and develop their potential.
We are proud to be an equal opportunity employer. We recruit, develop and reward without regard to, amongst others, gender, sexual orientation, gender identity or expression, national origin, age, physical or mental ability, race, ethnicity, political or religious belief.
If you are looking to join a company where you can try new things, speak openly, and be bold, we invite you to apply today.
