Some opportunities happen only once in a lifetime - like a job where you have the chance to change lives. At Alexion, people living with rare and devastating diseases are our Guiding Star. We are driven to continuously innovate and create meaningful value in all we do to help patients and families fully live their best lives. We value the uniqueness and diversity of our employees and recognize that nurturing the diverse perspectives and strengths of our people translates into innovative breakthroughs for patients.
This is what you will do:
This position is accountable for the timely preparation of high-quality clinical, regulatory documents supporting the clinical development portfolio at Alexion. This position will lead the medical writing (MW) activities across a disease area or set of clinical programs. This position will function with limited supervision as required.
You will be responsible for:
- Author and manage the completion of clinical documents, including clinical study protocols and amendments, clinical study reports, Investigator's Brochures and updates, and clinical Common Technical Document components (e.g., Module 2 summaries). Contribute to the development of briefing packages, responses to health authority inquiries, pediatric investigational plans, and other IND/CTA or global regulatory submission documents.
- Support clinical project teams by authoring and managing high-quality MW deliverables in terms of scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. Represent MW cross-functionally, negotiating timelines as necessary.
- Support development and implementation of strategy for writing and completion of high-quality clinical documents.
- Participate with other MW team members to develop and implement processes and standards and take responsibility for execution in cross-functional teams.
- Maintain adherence to standard operating procedures and regulatory requirements in partnership with statistical, clinical, regulatory, quality, and drug safety colleagues.
- Develop effective collaborations with other functional lines within Alexion and externally with regulatory, industry, professional, and academic organizations.
- Review, edit, and ensure the quality of documents or sections of documents prepared by other writers (internal or contractors) or functional area representatives as required and ensure adherence to standards.
- Mentor less experienced MW team members (internal and external), ensuring quality and efficiency in the production of clinical, and regulatory documents.
You will need to have:
- At least 5-7 years of clinical and regulatory MW experience, including global clinical studies and regulatory submissions. I will consider fewer years of MW experience combined with other relevant pharmaceutical industry experience.
- Demonstrated capability to write clinical study documents (e.g., clinical study protocols, clinical study reports, Investigator's Brochures, and Module 2 summaries).
- Excellent oral, written, and presentation skills; advanced user of MS Office suite.
- Thorough knowledge of global regulatory requirements and ICH/GCP guidelines.
- Skilled in project management, with emphasis on time management, organization, and negotiation.
- Results- and compliance-driven; set the standard of excellence for self and others.
- The duties of this role are generally conducted in an office environment. As is typical of an office-based role, employees must be able, with or without accommodation, to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours.
We would prefer for you to have:
- Ph.D. or MS degree in life sciences or advanced degree in a relevant scientific/clinical/regulatory field.
- Experience with global clinical studies and regulatory submissions.
- Ability to establish excellent internal and external relationships, including alliance partners and vendors.
- Team player who thrives in a team-based environment.
- A well-developed sense of ethics, responsibility, and respect for others.
- An agile learner with the ability to work both collaboratively and independently, seeking advice as required.
- High level of flexibility and ability to innovate and adapt to changing conditions.