Medical Writing Manager

PDC CRO · India

Pharmaceutical Development Company is a leading clinical research organization, providing a Full-Service End-to-End Solution for Phase I to IV clinical trials and NIS /RWE studies in the Middle East and Africa region. Our clients include pharmaceutical, biotechnology, medical device industries, other CROs, and academic organizations. Our team is experienced in managing clinical projects from beginning to completion, PDC has been recognized among the leaders as Clinical Research Organization in the region. Due to our successful development, we are looking for highly motivated and responsible candidates for the position below:

Name of position: Medical Writing Manager - Location: India

Essential Functions and Other Job Information

1. Coordination and control over the activities related to a specific medical writing (MW) project: development of all necessary documents for studies (Protocol, Investigator’s Brochure, ICF, Manual, Clinical Study Report, etc.) as well as other assignments (Advisory Board Meeting, Abstract & Manuscript, etc.)
2. Strict control over the compliance of deliverables’ milestones and timelines as per the contract obligations related to medical writing.
3. Be a first point of contact in case of issue, task, and time management of the MW project/s under their supervision.
4. Communication with sponsors, partnering CRO, external advisors, physicians, regulatory authorities, and follow-up on any requests, remarks and/ or issues regarding the MW activities.
5. Organization and performing of MW project team meetings.
6. Ensures the completeness and performs final check of MW project documents.
7. Conduct critical party evaluation and management through questionnaires and documents review.
8. Contribute to development and maintenance of databases related to MW activities and third-party management.
9. Collaboration with Data Science team regarding CRF or other documents development.
10. Collaboration with Data Science team and Statistics subject matter expert on development of possible questions from regulatory agencies upon MA applications.
11. Perform quality control checks as per procedures’ requirements or other demands.
12. Translates and validates translations of a variety of documents with focus on clinical research.
13. Execute any activities in compliance with applicable SOPs, instructions, and principles.
14. Participates in the organization and conducting of initial and ongoing training of company employees.
15. Timely coverage of all assigned trainings.

Qualifications

Education and Experience

• University degree with life science background or equivalent and relevant formal academic/

vocational qualification.

• At least 5 years of experience in the field of clinical research, with focus on medical writing

and regulatory

• Previous experience that provides the knowledge, skills, and abilities to perform the job

(comparable to at least 7 years).

Knowledge, Skills and Abilities

• Excellent knowledge of ICH-GCP, EMA and FDA Guidelines for CTs and MA applications as well

as applicable national regulations

• Proficiency in English language

• Ability to work with scientific literature, electronic libraries, and databases

• Ability to access and use a variety of computer software

• Appropriate MS Office Skills

• Good time management, multitasking, interpersonal skills, attention to details and excellent

communication skills

• Regular and consistent attendance

Working Conditions and Environment

• Work is performed in an office or home environment with exposure to electrical office

equipment

The Company Offer:

• Job-specific training
• Work for successful international company
• Excellent career development opportunity in a perspective professional field
• Competitive remuneration package and benefits
• Additional benefits related to work performance.

Website:

The Assigned Country: India

Only short-listed candidates will be contacted for interviews.

By submitting your application, you agree that your personal data will be processed by PDC in accordance with the applicable Data Protection Law and in strictly keeping your confidentiality.

We are committed to fostering a diverse and inclusive workplace where every individual is valued and respected. Employment decisions are based solely on qualifications, performance, and business needs.