Job Description

Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa.

Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities.

But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets.

As we continue to grow, we are seeking a Sr. Manager, Medical Writing. This is a remote based position and can be in Europe or on the East Coast of the US.

Scope of the role:

The Senior Manager, Medical Writing, leads authoring of complex documents for one or more clinical development program.

Your key responsibilities:

Leadership

• Train junior medical writers on best practices in medical writing and regulatory submission processes.
• Help oversee vendor partnerships.

Writing

• Lead author (including content planning, writing, and review) for clinical study protocols, clinical study reports (CSRs), investigator brochures, other study-level documentation required for clinical trials.
• Author individual modules of IND/CTA, NDA, MAA requests for information and briefing documents. etc.) for regulatory agencies.
• Review Summary of Clinical Efficacy (SCE) and Summary of Clinical Safety (SCS) statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

Quality Control

• Coordinate for the quality and compliance of written components to company standards as well as regulatory requirements.

Project Management

• Create document timelines and coordinate reviews with cross-functional teams and contract research organizations (CROs).
• Manage vendor/contract medical writers

Collaboration

• Collaborate with cross-functional teams to analyze complex scientific data for the above-mentioned document types.
• Lead the document review process for study-level, submission, and regulatory interaction documents, through management of timelines, scheduling of meetings, and incorporation of feedback from cross-functional team
• Represent Medical Writing on Clinical Study Team(s) (CST[s])

Literature Reviews

• Conduct thorough literature reviews and synthesize complex scientific data into clear and concise documentation.

Department Administration

• Oversee quality and adherence to document templates and standard operating procedures (SOPs)

Regulatory Standards

• Ensure all documents adhere to regulatory guidelines, formatting standards, and internal quality standards.
• Maintain up-to-date knowledge of industry trends and regulatory changes and provide oversight to ensure that standards are being applied through review of documents produced by other team members.

Who are you:

Work Experience / Education

• Bachelor's degree in life sciences with minimum 8 years’ relevant experience in medical writing or pharmaceutical industry and/or clinical research OR
• Advanced scientific degree (MS, PhD, Pharm D) with a strong background in relevant scientific discipline with minimum 5 years of relevant experience in medical writing or pharmaceutical industry and/or clinical research
• Experience supporting and/or leading individual components of INDs, NDAs, and MAAs, as well as briefing books

Competencies & Major Skills

• Strong verbal and written communications skills coupled with general knowledge of FDA and ICH rules, regulations and guidelines governing conduct of clinical studies and regulatory documents
• Detail-oriented, with good organizational, prioritization, and time management proficiencies; proactive approach.
• Ability to work cross-functionally
• Advanced computer software experience (including but not limited to MS Word, Excel, PowerPoint)
• Ability to interpret and present scientific and clinical trial data and understand statistical methods and analysis plans.
• Proven ability to facilitate issue/comment resolution as it relates to finalization of medical writing deliverables.

Ability to thrive and adapt in times of uncertainty

Why Join Alfasigma:

At Alfasigma, we foster a culture where the courage to innovate is key to our success.
We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development.

Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress.

Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.