Freelance Project Manager - Medical Communications
The Lockwood Group, LLCSalary not specified
Full Time
Mid-level (3 to 4 years), Senior (5 to 8 years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries
Requirements
- Bachelor’s degree in life sciences or related field; advanced degree (PhD, PharmD, or MS) preferred
- Prior managerial experience (including consultants) preferred
- 10+ years of medical writing experience in the biotech/pharma industry
Responsibilities
- Lead the medical writing function and establish best practices, processes, and standards to support clinical and regulatory documentation
- Author, review, and manage the development of clinical and regulatory documents, including protocols, investigator brochures, clinical study reports (CSRs), INDs, CTAs, briefing packages, and clinical sections of regulatory submissions
- Collaborate closely with Clinical Development, Clinical Operations, Biostatistics, Regulatory Affairs, and Nonclinical teams to ensure accuracy, consistency, and alignment across documents
- Serve as the medical writing lead on cross-functional project teams, ensuring deliverables meet timelines and quality standards
- Oversee external medical writing vendors and contractors, ensuring consistency with Septerna’s quality and style guidelines
- Contribute to regulatory submission planning and authoring strategy, including preparation for agency interactions
- Support publication planning and development, including abstracts, posters, and manuscripts as needed
- Mentor and provide strategic direction to team members as the company grows
Skills
Medical Writing
GPCR
Drug Discovery
Biotechnology
Preclinical Research
Therapeutics Development
Regulatory Writing
Superna
Data protection solutions for Dell EMC Isilon
About Superna
Superna Eyeglass provides data protection solutions specifically designed for Dell EMC Isilon storage systems. Their products include tools for data replication, disaster recovery, and compliance auditing, which help enterprise clients manage their data securely and efficiently. The software operates on a subscription model, allowing clients to receive regular updates and technical support. What sets Superna Eyeglass apart from competitors is its focus on the unique needs of Dell EMC Isilon users, enabling them to offer specialized services in the data protection market. The company's goal is to ensure that clients can maintain secure operations while meeting compliance requirements.
Ottawa, CanadaHeadquarters
2002Year Founded
BUYOUTCompany Stage
Data & Analytics, Enterprise SoftwareIndustries
51-200Employees
Risks
Emerging startups offer innovative solutions at lower costs, threatening market share.
Cloud-native solutions may outpace Superna's current offerings, reducing attractiveness.
Vulnerability in Dell EMC Isilon systems could impact client trust if not addressed.
Differentiation
Superna Eyeglass specializes in Dell EMC Isilon storage systems, carving a niche market.
The company offers a subscription model, ensuring ongoing software updates and support.
Superna provides tailored solutions for data replication, disaster recovery, and compliance auditing.
Upsides
Rising demand for hybrid cloud solutions boosts Superna's market potential.
New data privacy regulations increase demand for compliance auditing tools.
Ransomware threats drive demand for robust disaster recovery solutions.
Related Jobs
RemoteRemoteSenior Manager, Clinical Medical Writer
Bristol-Myers SquibbSalary not specified
- Full Time
- Senior (5 to 8 years), Expert & Leadership (9+ years)
RemoteDirector, Medical Affairs
AbbottSalary not specified
- Full Time
- Expert & Leadership (9+ years)
RemotePrincipal Medical Writer (Regulatory MW)
Thermo Fisher ScientificSalary not specified
- Full Time
- Senior (5 to 8 years), Expert & Leadership (9+ years)
RemoteSenior ICF Medical Writing Project Manager
Thermo Fisher ScientificSalary not specified
RemoteProject Manager - Medical Publications
The Lockwood Group, LLCSalary not specified
- Full Time
- Mid-level (3 to 4 years)