Sr. Manager, Medical Writing

Alfasigma•Morristown, MN

10d•Remote

About The Position

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.

Requirements

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
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

Responsibilities

Train junior medical writers on best practices in medical writing and regulatory submission processes.
Help oversee vendor partnerships.
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.
Coordinate for the quality and compliance of written components to company standards as well as regulatory requirements.
Create document timelines and coordinate reviews with cross-functional teams and contract research organizations (CROs).
Manage vendor/contract medical writers
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])
Conduct thorough literature reviews and synthesize complex scientific data into clear and concise documentation.
Oversee quality and adherence to document templates and standard operating procedures (SOPs)
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.