Regulatory Medical Writer
All Openings | Research Triangle Park, NC | Full Time
Humacyte, Inc., a biotechnology pioneer, discovers, develops and delivers innovative, award winning human biotherapies. We are currently developing multiple vascular tissue engineered therapies and expanding our business model. With a broad pipeline of potential new therapy applications, we continue to build our organization and scientific teams. We are looking for additional biomedical research and development colleagues to continue to build our expanding team.
Candidates will be expected to work both independently and collaboratively as part of the Humacyte organization. Applicants must be highly self-motivated, with solid communication skills, and demonstrates the ability to work in a team environment and lead other professionals and peers.
To author complex regulatory, clinical and safety documents ensuring the coordination and integration of the scientific, medical and regulatory input from development team members. To support the performance goals (including quality and timeliness) for filing worldwide regulatory dossiers as planned by the Development Teams.
Position reports to Chief Regulatory Officer
- Ensures that all assigned documents support the full development strategy to achieve target labeling objectives and timely approvals in key markets
- Partners with Clinical Development and Regulatory Affairs to provide medical writing for regulatory documents such as protocol amendments, Investigator brochures, clinical trial updates, requests for information, etc.
- Provides project management of all medical writing requirements for both the clinical and regulatory teams, to include timeline and resource management
- Partner with commercial team for medical writing components as related to materials for conferences, symposiums, package inserts and marketing materials
- Participates in relevant clinical team, regulatory team or commercial team discussions and ensures effective planning and management of timelines for all components of assigned documents
- Participates and/or leads document prototyping sessions including the design of data displays, document flow, logic and consistency for assigned project prototypes; critically reviews project specific model documents, maintains document prototypes/shell reports.
- Documents and implements consensus at meetings of determined data interpretation and key findings/messages.
- Authors complex clinical documents (e.g. protocols, clinical study reports, high level summary documents), and certain non-clinical documents (e.g. initial Investigator’s Brochure, updates for scientific journals, other publications) for timely submission to health authorities, editors or other required entities
- Reports on compliance related issues to senior leadership as required
- Other duties, as assigned
- Possess a positive attitude and optimistic outlook
- Strong ability to work in a fast-paced team environment with fluctuating priorities, and collaborate effectively with others
- Excellent organizational and time management skills with ability to set own priorities
- High degree of flexibility and adaptability
- Strong communication (verbal and written) and organizational skills
- Basic computer skills required, such as MS Word, Excel, PowerPoint, and Outlook
- Strong interpersonal, business and communication skills
- Excellent written and oral communication skills
- Demonstrate strong critical thinking skills with the ability to motivate others
- Ability to work effectively within a team to set goals, write technical and validation reports, resolve compliance issues in scientific and industry-standard terms, as required
- Routinely communicate findings and information to peers and other team members; transparency and knowledge sharing is expected and practiced
- Capable of writing management level reports and summaries
- Strong problem solving and analytical skills
- Detailed oriented, self-motivated and scientifically driven
- Demonstrated ability to work in a cross functional team
- Excellent communication and interpersonal skills
- Proactively investigate and resolve discrepancies
- Ability to resolve issues quality system issues, related to deviations, non-conformances change controls etc.
- Clearly communicates issues with co-workers and supervision and communicates in a timely manner
- Ability to work with mathematical concepts such as probability and statistical inference.
- Ability to read, analyze, and interpret common scientific and technical journals
- Ability to write presentations and articles for peer reviewed publications that conform to prescribed style and format
- MS/BS in sciences or engineering or healthcare field, with a minimum of 3 years (MS) to 5 years (BS) of experience in regulatory, safety or pharmacovigilance documentation.
- Excellent demonstrable understanding of ICMJE and GPP guidelines and regulations required
- Strong understanding of cGMP, ISO and ICH guidance’s in the biotech/life sciences environment
- Must demonstrate an outstanding command of the English language (read, write and speak). Experience with clinical and regulatory language a plus
- Proficient with Microsoft Word, Excel, PowerPoint and Visio, preferred
- Proficiency in image processing programs preferred
- Proficiency in bibliographic and e-publishing programs strongly preferred
- Stock Options
- 401k Plan with Matching
- Medical, Vision and Dental Plans
- Long Term/Short Term Disability
- Life Insurance
- 23 Days Paid Time Off (PTO)
- 11 Paid Holidays
- Paid Parental Leave Policies
- Career Development and Training
**Please note, Humacyte does not provide sponsorship at this time.**