Senior Medical Writer
Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences. We are better together and together We Are Altasciences.
About The Role
The Senior Medical Writer is responsible for gathering and synthesizing information for the purpose of providing high-quality documents to support the execution and reporting of sponsors' research programs.
What You’ll Do Here
- Serve as the Medical Writing representative on assigned project teams.
- Develop clinical protocols for clinical studies of any complexity.
- Review and provide feedback on client-provided protocols, as required.
- Contribute to risk assessment and management plans (RAMPs) for assigned studies.
- Review case report forms (CRFs) and statistical analysis plans (SAPs), as required, to ensure completeness and accuracy of clinical data collection and presentation for final analyses.
- Create clinical study reports (CSRs), standalone safety narratives, and integrated safety summaries for studies of any complexity and incorporate results and feedback from other departments assuring compliance with regulations, standard operating procedures (SOPs), Good Clinical Practice (GCP), and client expectations.
- Analyze and interpret clinical and safety results for studies of any complexity including vital signs, clinical laboratory values, adverse events (AEs), electrocardiograms (ECGs), diagnostic procedures, etc.
- Confirm accurate classification of events and medications using standardized coding systems.
- Prepare and review CSR appendices in accordance with project/client specifications and International Conference on Harmonisation (ICH) E3 guidance.
- Review and provide assistance on answering deficiency letters from regulatory agencies.
- Perform literature searches/reviews as necessary to obtain background information for development of documents.
- Coordinate internal review and manage incorporation of external feedback for protocol and CSR documents assuring feedback is appropriately addressed.
- Perform quality control (QC) and editorial review of documents prepared by other team members for completeness, accuracy, consistency, structure, and grammar.
- Actively participate in internal and external project team meetings, as required.
- Coordinate with internal team to deliver high-quality documents in accordance with agreed upon timelines.
- Maintain thorough understanding of regulatory guidelines of related authorities (Therapeutic Products Directorate [TPD], Food and Drug Administration [FDA], European Medicines Agency [EMA], etc) as well as ICH and GCP procedures.
- Participate in departmental or interdepartmental quality improvement initiatives.
- Support training of Medical Writers and Medical Writing Associates.
What You’ll Need to Succeed
- Master’s Degree in health-related sciences or relevant field, advanced degree;
- Investigator Brochure (IB) experience is a must;
- Early-phase CRO experience is a must;
- Excellent verbal and written communication skills.
- Ability to acquire and apply knowledge quickly.
- Professional attitude and strong interpersonal skills.
- Ability to work well with a multi-disciplinary team of professionals.
- Client-focused approach to work.
- Superior attention to detail.
- Understanding of clinical research, drug development process, and applicable regulatory guidelines.
- Strong computer skills (Microsoft Word, Excel, and Power Point) and ability to understand and adapt to various information technology (IT) systems
What We Offer
Benefits (regular employees)
Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.
Altasciences' BenefitsPackage Includes:
- Health/Dental/Vision Insurance Plans
- 401(k)/RRSP with Employer Match
- Paid Vacation and Holidays
- Paid Sick and Bereavement Leave
- Employee Assistance & Telehealth Programs
- Telework when applicable
Altasciences' Incentive Programs Include:
- Training & Development Programs
- Employee Referral Bonus Program
- Pay Type Salary